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Clinical Trial Results:
Effect of MD1003 in spinal progressive multiple sclerosis: a pivotal randomized double blind placebo controlled study

Summary
EudraCT number	2013-002113-35
Trial protocol	FR
Global end of trial date	04 Jun 2020

Results information
Results version number	v1(current)
This version publication date	19 Nov 2020
First version publication date	19 Nov 2020
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

Top of page

Sponsor protocol code

MD1003CT2013-02MS-SPI

ISRCTN number

US NCT number

WHO universal trial number (UTN)

Sponsor organisation name

Medday Pharmaceuticals S.A.

Sponsor organisation address

24-26 rue de la Pépinière, Paris, France,

Public contact

Clinical Trials Information Desk, Medday Pharmaceuticals S.A., +33 0180401465,

Scientific contact

Clinical Trials Information Desk, Medday Pharmaceuticals S.A., +33 0180401465,

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

04 Jun 2020

Is this the analysis of the primary completion data?

Yes

Primary completion date

24 Feb 2015

Global end of trial reached?

Yes

Global end of trial date

04 Jun 2020

Was the trial ended prematurely?

Main objective of the trial

To demonstrate the superiority of MD1003 300 mg/day over placebo in clinical improvement of patients with spinal progressive multiple sclerosis.

Protection of trial subjects

This protocol complied with the principal laid down by the 18th World Medical Assembly (Helsinki, 1964 an following amendments) and all applicable amendments laid down by the World Medical Assemblies, as well as the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. The trial complied with the laws and regulations of the country in which the study was performed, and any applicable guidelines.

Background therapy

Evidence for comparator

Actual start date of recruitment

02 Sep 2013

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

France: 154

Worldwide total number of subjects

154

EEA total number of subjects

154

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

152

From 65 to 84 years

85 years and over

Subject disposition

Top of page

Recruitment details

Screening details

Number of subjects started

166 ^[1]

Number of subjects completed

154

Reason: Number of subjects

inclusion/exclusion criteria: 12

Notes
[1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
Justification: the difference is the number of screen failures.

Period 1 title

Double-blind phase

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Monitor, Data analyst, Carer, Assessor

Are arms mutually exclusive

Yes

MD1003

Arm description

Arm type

Experimental

Investigational medicinal product name

MD1003

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

100 mg 3 times/day (1 capsule in the morning, 1 at noon, 1 in the evening)

Placebo

Arm description

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

One placebo capsule 3 times/day

Number of subjects in period 1	MD1003	Placebo
Started	103	51
Completed	91	42
Not completed	12	9
Consent withdrawn by subject	5	4
Physician decision	3	2
Adverse event, non-fatal	3	3
Protocol deviation	1	-

Period 2 title

Open-label extension phase M12-M78

Is this the baseline period?

Allocation method

Not applicable

Blinding used

Not blinded

Are arms mutually exclusive

Yes

MD1003-MD1003

Arm description

MD1003 300 mg/day for 12 months in the double-blind phase and MD1003 300 mg/day for 66 additional months in the open-label extension phase.

Arm type

Experimental

Investigational medicinal product name

MD1003

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

100 mg 3 times/day (1 capsule in the morning, 1 at noon, 1 in the evening)

Placebo-MD1003

Arm description

Placebo for 12 months in the double-blind phase, then switch to MD1003 300 mg/day for 66 additional months in the open-label extension phase.

Arm type

Experimental

Investigational medicinal product name

MD1003

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

100 mg 3 times/day (1 capsule in the morning, 1 at noon, 1 in the evening)

Number of subjects in period 2	MD1003-MD1003	Placebo-MD1003
Started	91	42
Completed	36	19
Not completed	55	23
Consent withdrawn by subject	13	8
Adverse event, non-fatal	7	3
Other	9	3
Lack of efficacy	26	9

Baseline characteristics

Top of page

Reporting group title

MD1003

Reporting group description

Reporting group title

Placebo

Reporting group description

Reporting group values	MD1003	Placebo	Total
Number of subjects	103	51	154
Age categorical
Units: Subjects
In utero	0	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0	0
Newborns (0-27 days)	0	0	0
Infants and toddlers (28 days-23 months)	0	0	0
Children (2-11 years)	0	0	0
Adolescents (12-17 years)	0	0	0
Adults (18-64 years)	101	0	101
From 65-84 years	2	51	53
85 years and over	0	0	0
Age continuous
Units: years
arithmetic mean (standard deviation)	51.8 ± 9.1	50.7 ± 8.4	-
Gender categorical
Units: Subjects
Female	53	30	83
Male	50	21	71
Demographic characteristics at baseline by baseline EDSS
Units: Subjects
EDSS 4.5 to 5.5	28	7	35
EDSS 6 to 7	75	44	119

Subject analysis set title

ITT population

Subject analysis set type

Intention-to-treat

Subject analysis set description

All randomized patients who received at least one dose of study medication and with at least one baseline EDSS and one baseline TW25 assessment will be included. All analyses will be performed according to the intent-to-treat principle, i.e. patients will be analyzed according to the treatment arm they were assigned to.

Subject analysis set title

Safety set

Subject analysis set type

Safety analysis

Subject analysis set description

All patients who received at least one dose of study medication will be included in the Safety population. Patients were analyzed according to the treatment they actually received.

Subject analysis sets values	ITT population	Safety set
Number of subjects	154	154
Age categorical
Units: Subjects
In utero	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0
Newborns (0-27 days)	0	0
Infants and toddlers (28 days-23 months)	0	0
Children (2-11 years)	0	0
Adolescents (12-17 years)	0	0
Adults (18-64 years)	152	152
From 65-84 years	2	2
85 years and over	0	0
Age continuous
Units: years
arithmetic mean (standard deviation)	51.4 ± 8.9	51.4 ± 8.9
Gender categorical
Units: Subjects
Female	83	83
Male	71	71
Demographic characteristics at baseline by baseline EDSS
Units: Subjects
EDSS 4.5 to 5.5	35	35
EDSS 6 to 7	119	119

End points

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Reporting group title

MD1003

Reporting group description

Reporting group title

Placebo

Reporting group description

Reporting group title

MD1003-MD1003

Reporting group description

MD1003 300 mg/day for 12 months in the double-blind phase and MD1003 300 mg/day for 66 additional months in the open-label extension phase.

Reporting group title

Placebo-MD1003

Reporting group description

Placebo for 12 months in the double-blind phase, then switch to MD1003 300 mg/day for 66 additional months in the open-label extension phase.

Subject analysis set title

ITT population

Subject analysis set type

Intention-to-treat

Subject analysis set description

Subject analysis set title

Safety set

Subject analysis set type

Safety analysis

Subject analysis set description

All patients who received at least one dose of study medication will be included in the Safety population. Patients were analyzed according to the treatment they actually received.

Primary: Proportion of patients with improvement of either the EDSS or the TW25 at M9 confirmed at M12

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End point title

Proportion of patients with improvement of either the EDSS or the TW25 at M9 confirmed at M12

End point description

• Improvement of Expanded Disability Status Scale (EDSS) at M9 confirmed at M12 is defined as: - A decrease of at least ≥ 0.5 point if baseline EDSS within [6; 7] - A decrease of at least ≥ 1 point if baseline EDSS within [4.5; 5.5] • Improvement of Time to Walk 25 Feet (TW25) is defined as a decrease of at least ≥ 20% at M9 confirmed at M12 compared to baseline TW25.

End point type

Primary

End point timeframe

M0-M12

End point values	MD1003	Placebo
Number of subjects analysed	103	51
Units: Number of patients	13	0

Fisher's exact test

Comparison groups

MD1003 v Placebo

Number of subjects included in analysis

154

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.0051

Method

Fisher exact

Confidence interval

Secondary: CGI score at M12

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End point title

CGI score at M12

End point description

The Clinical Global Impression - Improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. The 7-point scale goes from: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.

End point type

Secondary

End point timeframe

M0-M12

End point values	MD1003	Placebo
Number of subjects analysed	94	45
Units: CGI score
arithmetic mean (standard deviation)	4.05 ± 0.81	4.62 ± 0.75

Mann-Whitney's U test

Comparison groups

MD1003 v Placebo

Number of subjects included in analysis

139

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.0001

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Secondary: Proportions of patients with improvement of both EDSS and TW25 at M9 and confirmed at M12

Top of page

End point title

Proportions of patients with improvement of both EDSS and TW25 at M9 and confirmed at M12

End point description

Improvement of both EDSS and TW25 is defined as follows: - decreased EDSS (at least 0.5 point if baseline EDSS from 6 to 7 and at least 1 point if baseline EDSS from 4.5 to 5.5) and - decreased TW25 (at least 20%) at M9 confimred at M12.

End point type

Secondary

End point timeframe

M0-M12

End point values	MD1003	Placebo
Number of subjects analysed	103	51
Units: Number of patients
number (not applicable)	2	0

Fisher's exact test

Comparison groups

MD1003 v Placebo

Number of subjects included in analysis

154

Analysis specification

Pre-specified

Analysis type

other

P-value

= 1

Method

Fisher exact

Confidence interval

Secondary: Proportion of patients with increased EDSS score at M9 and confirmed at M12

Top of page

End point title

Proportion of patients with increased EDSS score at M9 and confirmed at M12

End point description

Increased EDSS score is defined as: - An increase of at least ≥ 0.5 point if baseline EDSS within the [6; 7] range; - An increase of at least ≥ 1 point if baseline EDSS within the [4.5; 5.5] range.

End point type

Secondary

End point timeframe

M0-M12

End point values	MD1003	Placebo
Number of subjects analysed	95	44
Units: Number of patients
number (not applicable)	4	6

Fisher's exact test

Comparison groups

MD1003 v Placebo

Number of subjects included in analysis

139

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.0727

Method

Fisher exact

Confidence interval

Secondary: Proportion of patients with stable EDSS score at M9 and confirmed at M12

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End point title

Proportion of patients with stable EDSS score at M9 and confirmed at M12

End point description

The definition of stable EDSS is by default: it corresponds to all patients excluding those with decreased and those with increased EDSS score.

End point type

Secondary

End point timeframe

M0-M12

End point values	MD1003	Placebo
Number of subjects analysed	103	51
Units: Number of patients
number (not applicable)	81	38

Fisher's exact test

Comparison groups

MD1003 v Placebo

Number of subjects included in analysis

154

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.6832

Method

Fisher exact

Confidence interval

Secondary: Mean change in General Health Sub-score of the SF36 questionnaire between M0 and M12

Top of page

End point title

Mean change in General Health Sub-score of the SF36 questionnaire between M0 and M12

End point description

End point type

Secondary

End point timeframe

M0-M12

End point values	MD1003	Placebo
Number of subjects analysed	103	51
Units: SF36 score
arithmetic mean (standard deviation)	-4.43 ± 16.75	2.25 ± 16.23

Mann-Whitney's U test

Comparison groups

MD1003 v Placebo

Number of subjects included in analysis

154

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.0349

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Secondary: Mean change in the fatigue impact scale (M-FIS) between M0 and M12

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End point title

Mean change in the fatigue impact scale (M-FIS) between M0 and M12

End point description

End point type

Secondary

End point timeframe

M0-M12

End point values	MD1003	Placebo
Number of subjects analysed	96	47
Units: Fatigue impact scale
arithmetic mean (standard deviation)	1.38 ± 16.04	1.30 ± 15.69

Mann-Whitney's U test

Comparison groups

MD1003 v Placebo

Number of subjects included in analysis

143

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.8466

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Secondary: Mean change of the Nine Hole Peg Test (9HPT) between M0 and M12 (Best hand)

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End point title

Mean change of the Nine Hole Peg Test (9HPT) between M0 and M12 (Best hand)

End point description

End point type

Secondary

End point timeframe

M0-M12

End point values	MD1003	Placebo
Number of subjects analysed	95	47
Units: 9HPT score
arithmetic mean (standard deviation)	2.06 ± 5.21	1.40 ± 7.06

Mann-Whitney's U test

Comparison groups

MD1003 v Placebo

Number of subjects included in analysis

142

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.9757

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Secondary: Mean change in sub-score of the Kurtzke functional score between M0 and M12 (visual)

Top of page

End point title

Mean change in sub-score of the Kurtzke functional score between M0 and M12 (visual)

End point description

End point type

Secondary

End point timeframe

M0-M12

End point values	MD1003	Placebo
Number of subjects analysed	103	51
Units: Kurtzke fonctionnal score
arithmetic mean (standard deviation)	0.05 ± 0.81	-0.10 ± 0.5

Mann-Whitney's U test

Comparison groups

MD1003 v Placebo

Number of subjects included in analysis

154

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.183

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Secondary: Mean change in EDSS between M0 and M18

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End point title

Mean change in EDSS between M0 and M18

End point description

End point type

Secondary

End point timeframe

M0-M18

End point values	MD1003-MD1003	Placebo-MD1003
Number of subjects analysed	87	41
Units: EDSS score
arithmetic mean (standard deviation)	-0.02 ± 0.61	0.13 ± 0.45

Mann-Whitney's U test

Comparison groups

Placebo-MD1003 v MD1003-MD1003

Number of subjects included in analysis

128

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.0273

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Secondary: Mean change in EDSS between M0 and M24

Top of page

End point title

Mean change in EDSS between M0 and M24

End point description

End point type

Secondary

End point timeframe

M0-M24

End point values	MD1003-MD1003	Placebo-MD1003
Number of subjects analysed	82	41
Units: EDSS score
arithmetic mean (standard deviation)	0.04 ± 0.62	0.15 ± 0.37

Mann-Whitney's U test

Comparison groups

MD1003-MD1003 v Placebo-MD1003

Number of subjects included in analysis

123

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.1283

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Secondary: Mean change in EDSS between M0 and M30

Top of page

End point title

Mean change in EDSS between M0 and M30

End point description

End point type

Secondary

End point timeframe

M0-M30

End point values	MD1003-MD1003	Placebo-MD1003
Number of subjects analysed	70	37
Units: EDSS score
arithmetic mean (standard deviation)	0.1 ± 0.68	0.23 ± 0.3

Mann-Whitney's U test

Comparison groups

MD1003-MD1003 v Placebo-MD1003

Number of subjects included in analysis

107

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.041

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Secondary: Mean change in EDSS between M0 and M36

Top of page

End point title

Mean change in EDSS between M0 and M36

End point description

End point type

Secondary

End point timeframe

M0-M36

End point values	MD1003-MD1003	Placebo-MD1003
Number of subjects analysed	64	33
Units: EDSS score
arithmetic mean (standard deviation)	0.11 ± 0.69	0.18 ± 0.33

Mann-Whitney's U test

Comparison groups

MD1003-MD1003 v Placebo-MD1003

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.4285

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Secondary: Mean change in EDSS between M0 and M42

Top of page

End point title

Mean change in EDSS between M0 and M42

End point description

End point type

Secondary

End point timeframe

M0-M42

End point values	MD1003-MD1003	Placebo-MD1003
Number of subjects analysed	55	29
Units: EDSS score
arithmetic mean (standard deviation)	0.17 ± 0.73	0.28 ± 0.56

Mann-Whitney's U test

Comparison groups

MD1003-MD1003 v Placebo-MD1003

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.3653

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Secondary: Mean change in EDSS between M0 and M48

Top of page

End point title

Mean change in EDSS between M0 and M48

End point description

End point type

Secondary

End point timeframe

M0-M48

End point values	MD1003-MD1003	Placebo-MD1003
Number of subjects analysed	52	26
Units: EDSS score
arithmetic mean (standard deviation)	0.16 ± 0.77	0.4 ± 0.49

Mann-Whitney's U test

Comparison groups

Placebo-MD1003 v MD1003-MD1003

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.1742

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Secondary: Mean change in EDSS between M0 and M54

Top of page

End point title

Mean change in EDSS between M0 and M54

End point description

End point type

Secondary

End point timeframe

M0-M54

End point values	MD1003-MD1003	Placebo-MD1003
Number of subjects analysed	42	23
Units: EDSS score
arithmetic mean (standard deviation)	0.17 ± 0.75	0.43 ± 0.51

Mann-Whitney's U test

Comparison groups

MD1003-MD1003 v Placebo-MD1003

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.135

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Secondary: Mean change in EDSS between M0 and M60

Top of page

End point title

Mean change in EDSS between M0 and M60

End point description

End point type

Secondary

End point timeframe

M0-M60

End point values	MD1003-MD1003	Placebo-MD1003
Number of subjects analysed	40	22
Units: EDSS score
arithmetic mean (standard deviation)	0.21 ± 0.75	0.39 ± 0.43

Mann-Whitney's U test

Comparison groups

MD1003-MD1003 v Placebo-MD1003

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.25

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Secondary: Mean change in the MS walking scale (MSWS) between M0 and M24

Top of page

End point title

Mean change in the MS walking scale (MSWS) between M0 and M24

End point description

End point type

Secondary

End point timeframe

M0-M24

End point values	MD1003-MD1003	Placebo-MD1003
Number of subjects analysed	85	38
Units: MSWS
arithmetic mean (standard deviation)	2.06 ± 17.22	5.05 ± 27.07

Mann-Whitney's U test

Comparison groups

MD1003-MD1003 v Placebo-MD1003

Number of subjects included in analysis

123

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.6415

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Secondary: Mean change in the MS walking scale (MSWS) between M0 and M12

Top of page

End point title

Mean change in the MS walking scale (MSWS) between M0 and M12

End point description

End point type

Secondary

End point timeframe

M0-M12

End point values	MD1003	Placebo
Number of subjects analysed	95	46
Units: MSWS
arithmetic mean (standard deviation)	0.79 ± 17.12	5.26 ± 22.51

Mann-Whitney's U test

Comparison groups

MD1003 v Placebo

Number of subjects included in analysis

141

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.8118

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Secondary: CGI score at M24

Top of page

End point title

CGI score at M24

End point description

End point type

Secondary

End point timeframe

M24

End point values	MD1003-MD1003	Placebo-MD1003
Number of subjects analysed	90	42
Units: CGI score
arithmetic mean (standard deviation)	4.17 ± 0.97	4.24 ± 0.73

Mann-Whitney's U test

Comparison groups

Placebo-MD1003 v MD1003-MD1003

Number of subjects included in analysis

132

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.8173

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Secondary: CGI score at M36

Top of page

End point title

CGI score at M36

End point description

End point type

Secondary

End point timeframe

M36

End point values	MD1003-MD1003	Placebo-MD1003
Number of subjects analysed	90	42
Units: CGI score
arithmetic mean (standard deviation)	4.28 ± 0.97	4.29 ± 0.81

Mann-Whitney's U test

Comparison groups

MD1003-MD1003 v Placebo-MD1003

Number of subjects included in analysis

132

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.9648

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Secondary: Mean percent change in TW25 between M0 and M12

Top of page

End point title

Mean percent change in TW25 between M0 and M12

End point description

End point type

Secondary

End point timeframe

M0-M12

End point values	MD1003	Placebo
Number of subjects analysed	94	42
Units: TW25
arithmetic mean (standard deviation)	67.71 ± 203.27	98.18 ± 253.73

Mann-Whitney's U test

Comparison groups

Placebo v MD1003

Number of subjects included in analysis

136

Analysis specification

Post-hoc

Analysis type

other

P-value

= 0.6393

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Secondary: Mean percent change in TW25 between M0 and M24

Top of page

End point title

Mean percent change in TW25 between M0 and M24

End point description

End point type

Secondary

End point timeframe

M0-M24

End point values	MD1003-MD1003	Placebo-MD1003
Number of subjects analysed	80	39
Units: TW25
arithmetic mean (standard deviation)	95.77 ± 221.26	121.51 ± 256.29

Mann-Whitney's U test

Comparison groups

MD1003-MD1003 v Placebo-MD1003

Number of subjects included in analysis

119

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.823

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Secondary: Mean percent change in TW25 between M0 and M36

Top of page

End point title

Mean percent change in TW25 between M0 and M36

End point description

End point type

Secondary

End point timeframe

M0-M36

End point values	MD1003-MD1003	Placebo-MD1003
Number of subjects analysed	60	30
Units: TW25
arithmetic mean (standard deviation)	125.28 ± 387.7	165.11 ± 297.1

Mann-Whitney's U test

Comparison groups

MD1003-MD1003 v Placebo-MD1003

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.4669

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Secondary: Proportions of patients with improvement of both EDSS and TW25 at M18 and confirmed at M24

Top of page

End point title

Proportions of patients with improvement of both EDSS and TW25 at M18 and confirmed at M24

End point description

End point type

Secondary

End point timeframe

M18-M24

End point values	MD1003-MD1003	Placebo-MD1003
Number of subjects analysed	91	42
Units: Number of patients
number (not applicable)	2	0

Fisher's exact test

Comparison groups

MD1003-MD1003 v Placebo-MD1003

Number of subjects included in analysis

133

Analysis specification

Pre-specified

Analysis type

other

P-value

= 1

Method

Fisher exact

Confidence interval

Secondary: Proportions of patients with improvement of both EDSS and TW25 at M24 and confirmed at M30

Top of page

End point title

Proportions of patients with improvement of both EDSS and TW25 at M24 and confirmed at M30

End point description

End point type

Secondary

End point timeframe

M24-M30

End point values	MD1003-MD1003	Placebo-MD1003
Number of subjects analysed	91	42
Units: Number of patients
number (not applicable)	1	0

Fisher's exact test

Comparison groups

MD1003-MD1003 v Placebo-MD1003

Number of subjects included in analysis

133

Analysis specification

Pre-specified

Analysis type

other

P-value

= 1

Method

Fisher exact

Confidence interval

Secondary: Proportions of patients with improvement of both EDSS and TW25 at M36 and confirmed at M42

Top of page

End point title

Proportions of patients with improvement of both EDSS and TW25 at M36 and confirmed at M42

End point description

End point type

Secondary

End point timeframe

M36-M42

End point values	MD1003-MD1003	Placebo-MD1003
Number of subjects analysed	91	42
Units: Number of patients
number (not applicable)	0	0

Fisher's exact test

Comparison groups

MD1003-MD1003 v Placebo-MD1003

Number of subjects included in analysis

133

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0 ^[1]

Method

Fisher exact

Confidence interval

Notes
[1] - No p-value had been calculated

Secondary: Proportions of patients with improvement of both EDSS and TW25 at M30 and confirmed at M36

Top of page

End point title

Proportions of patients with improvement of both EDSS and TW25 at M30 and confirmed at M36

End point description

End point type

Secondary

End point timeframe

M30-M36

End point values	MD1003-MD1003	Placebo-MD1003
Number of subjects analysed	91	42
Units: Number of patients
number (not applicable)	0	0

Fisher's exact test

Comparison groups

MD1003-MD1003 v Placebo-MD1003

Number of subjects included in analysis

133

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0 ^[2]

Method

Fisher exact

Confidence interval

Notes
[2] - No p-value had been calculated

Secondary: Proportions of patients with improvement of both EDSS and TW25 at M42 and confirmed at M48

Top of page

End point title

Proportions of patients with improvement of both EDSS and TW25 at M42 and confirmed at M48

End point description

End point type

Secondary

End point timeframe

M42-M48

End point values	MD1003-MD1003	Placebo-MD1003
Number of subjects analysed	91	42
Units: Number of patients
number (not applicable)	0	0

Fisher's exact test

Comparison groups

Placebo-MD1003 v MD1003-MD1003

Number of subjects included in analysis

133

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0 ^[3]

Method

Fisher exact

Confidence interval

Notes
[3] - No p-value had been calculated

Secondary: Proportions of patients with improvement of both EDSS and TW25 at M48 and confirmed at M54

Top of page

End point title

Proportions of patients with improvement of both EDSS and TW25 at M48 and confirmed at M54

End point description

End point type

Secondary

End point timeframe

M48-M54

End point values	MD1003-MD1003	Placebo-MD1003
Number of subjects analysed	91	42
Units: Number of patients
number (not applicable)	0	0

Fisher's exact test

Comparison groups

MD1003-MD1003 v Placebo-MD1003

Number of subjects included in analysis

133

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0 ^[4]

Method

Fisher exact

Confidence interval

Notes
[4] - No p-value had been calculated

Secondary: Proportion of patients with increased EDSS score at M18 confirmed at M24

Top of page

End point title

Proportion of patients with increased EDSS score at M18 confirmed at M24

End point description

End point type

Secondary

End point timeframe

M18-M24

End point values	MD1003-MD1003	Placebo-MD1003
Number of subjects analysed	81	41
Units: Number of patients
number (not applicable)	8	13

Fisher's exact test

Comparison groups

MD1003-MD1003 v Placebo-MD1003

Number of subjects included in analysis

122

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.0045

Method

Fisher exact

Confidence interval

Secondary: Proportion of patients with increased EDSS score at M12 and confirmed at M18

Top of page

End point title

Proportion of patients with increased EDSS score at M12 and confirmed at M18

End point description

End point type

Secondary

End point timeframe

M12-M18

End point values	MD1003-MD1003	Placebo-MD1003
Number of subjects analysed	87	40
Units: Number of patients
number (not applicable)	7	7

Fisher's exact test

Comparison groups

MD1003-MD1003 v Placebo-MD1003

Number of subjects included in analysis

127

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.1332

Method

Fisher exact

Confidence interval

Secondary: Proportion of patients with increased EDSS score at M24 and confirmed at M30

Top of page

End point title

Proportion of patients with increased EDSS score at M24 and confirmed at M30

End point description

End point type

Secondary

End point timeframe

M24-M30

End point values	MD1003-MD1003	Placebo-MD1003
Number of subjects analysed	69	36
Units: Number of patients
number (not applicable)	10	10

Fisher's exact test

Comparison groups

MD1003-MD1003 v Placebo-MD1003

Number of subjects included in analysis

105

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.1199

Method

Fisher exact

Confidence interval

Secondary: Proportion of patients with increased EDSS score at M30 and confirmed at M36

Top of page

End point title

Proportion of patients with increased EDSS score at M30 and confirmed at M36

End point description

End point type

Secondary

End point timeframe

M30-M36

End point values	MD1003-MD1003	Placebo-MD1003
Number of subjects analysed	64	33
Units: Number of patients
number (not applicable)	12	9

Fisher's exact test

Comparison groups

MD1003-MD1003 v Placebo-MD1003

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.4357

Method

Fisher exact

Confidence interval

Secondary: Proportion of patients with increased EDSS score at M36 and confirmed at M42

Top of page

End point title

Proportion of patients with increased EDSS score at M36 and confirmed at M42

End point description

End point type

Secondary

End point timeframe

M36-M42

End point values	MD1003-MD1003	Placebo-MD1003
Number of subjects analysed	55	29
Units: Number of patients
number (not applicable)	14	8

Fisher's exact test

Comparison groups

MD1003-MD1003 v Placebo-MD1003

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

P-value

= 1

Method

Fisher exact

Confidence interval

Secondary: Proportion of patients with increased EDSS score at M42 and confirmed at M48

Top of page

End point title

Proportion of patients with increased EDSS score at M42 and confirmed at M48

End point description

End point type

Secondary

End point timeframe

M42-M48

End point values	MD1003-MD1003	Placebo-MD1003
Number of subjects analysed	51	26
Units: Number of patients
number (not applicable)	12	8

Fisher's exact test

Comparison groups

MD1003-MD1003 v Placebo-MD1003

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.5851

Method

Fisher exact

Confidence interval

Secondary: Proportion of patients with increased EDSS score at M48 and confirmed at M54

Top of page

End point title

Proportion of patients with increased EDSS score at M48 and confirmed at M54

End point description

End point type

Secondary

End point timeframe

M48-M54

End point values	MD1003-MD1003	Placebo-MD1003
Number of subjects analysed	42	23
Units: Number of patients
number (not applicable)	12	8

Fisher's exact test

Comparison groups

MD1003-MD1003 v Placebo-MD1003

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.7792

Method

Fisher exact

Confidence interval

Secondary: Proportion of patients with increased EDSS score at M54 and confirmed at M60

Top of page

End point title

Proportion of patients with increased EDSS score at M54 and confirmed at M60

End point description

End point type

Secondary

End point timeframe

M54-M60

End point values	MD1003-MD1003	Placebo-MD1003
Number of subjects analysed	40	22
Units: Number of patients
number (not applicable)	14	8

Fisher's exact test

Comparison groups

MD1003-MD1003 v Placebo-MD1003

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

P-value

= 1

Method

Fisher exact

Confidence interval

Secondary: Proportion of patients with stable EDSS score at M12 and confirmed at M18

Top of page

End point title

Proportion of patients with stable EDSS score at M12 and confirmed at M18

End point description

The definition of stable EDSS is by default: it corresponds to all patients excluding those with decreased and those with increased EDSS score.

End point type

Secondary

End point timeframe

M12-M18

End point values	MD1003-MD1003	Placebo-MD1003
Number of subjects analysed	91	42
Units: Number of patients
number (not applicable)	72	32

Fisher's exact test

Comparison groups

MD1003-MD1003 v Placebo-MD1003

Number of subjects included in analysis

133

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.8216

Method

Fisher exact

Confidence interval

Secondary: Proportion of patients with stable EDSS score at M24 and confirmed at M30

Top of page

End point title

Proportion of patients with stable EDSS score at M24 and confirmed at M30

End point description

The definition of stable EDSS is by default: it corresponds to all patients excluding those with decreased and those with increased EDSS score.

End point type

Secondary

End point timeframe

M24-M30

End point values	MD1003-MD1003	Placebo-MD1003
Number of subjects analysed	91	42
Units: Number of patients
number (not applicable)	53	26

Fisher's exact test

Comparison groups

MD1003-MD1003 v Placebo-MD1003

Number of subjects included in analysis

133

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.7089

Method

Fisher exact

Confidence interval

Secondary: Proportion of patients with stable EDSS score at M36 and confirmed at M42

Top of page

End point title

Proportion of patients with stable EDSS score at M36 and confirmed at M42

End point description

The definition of stable EDSS is by default: it corresponds to all patients excluding those with decreased and those with increased EDSS score.

End point type

Secondary

End point timeframe

M36-M42

End point values	MD1003-MD1003	Placebo-MD1003
Number of subjects analysed	91	42
Units: Number of patients
number (not applicable)	33	21

Fisher's exact test

Comparison groups

MD1003-MD1003 v Placebo-MD1003

Number of subjects included in analysis

133

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.1833

Method

Fisher exact

Confidence interval

Secondary: Proportion of patients with stable EDSS score at M48 and confirmed at M54

Top of page

End point title

Proportion of patients with stable EDSS score at M48 and confirmed at M54

End point description

The definition of stable EDSS is by default: it corresponds to all patients excluding those with decreased and those with increased EDSS score.

End point type

Secondary

End point timeframe

M48-M54

End point values	MD1003-MD1003	Placebo-MD1003
Number of subjects analysed	91	42
Units: Number of patients
number (not applicable)	24	15

Fisher's exact test

Comparison groups

MD1003-MD1003 v Placebo-MD1003

Number of subjects included in analysis

133

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.3083

Method

Fisher exact

Confidence interval

Secondary: Mean change of the General Health Sub-score of the SF36 questionnaire between M0 and M24

Top of page

End point title

Mean change of the General Health Sub-score of the SF36 questionnaire between M0 and M24

End point description

End point type

Secondary

End point timeframe

M0-M24

End point values	MD1003-MD1003	Placebo-MD1003
Number of subjects analysed	91	42
Units: SF36 score
arithmetic mean (standard deviation)	-3.95 ± 15.68	1.37 ± 19.26

Mann-Whitney's U test

Comparison groups

MD1003-MD1003 v Placebo-MD1003

Number of subjects included in analysis

133

Analysis specification

Pre-specified

Analysis type

other ^[5]

P-value

= 0.1722

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[5] - The LOCF method was used.

Secondary: Mean change in the fatigue impact scale (M-FIS) between M0 and M24

Top of page

End point title

Mean change in the fatigue impact scale (M-FIS) between M0 and M24

End point description

End point type

Secondary

End point timeframe

M0-M24

End point values	MD1003-MD1003	Placebo-MD1003
Number of subjects analysed	85	38
Units: FIS
arithmetic mean (standard deviation)	-0.40 ± 13.49	0.79 ± 13.88

Mann-Whitney's U test

Comparison groups

MD1003-MD1003 v Placebo-MD1003

Number of subjects included in analysis

123

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.9716

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Secondary: Mean change of the Nine Hole Peg Test (9HPT) between M0 and M24 (best hand)

Top of page

End point title

Mean change of the Nine Hole Peg Test (9HPT) between M0 and M24 (best hand)

End point description

End point type

Secondary

End point timeframe

M0-M24

End point values	MD1003-MD1003	Placebo-MD1003
Number of subjects analysed	88	38
Units: 9HPT score
arithmetic mean (standard deviation)	3.43 ± 8.44	2.76 ± 9.20

Mann-Whitney's U test

Comparison groups

MD1003-MD1003 v Placebo-MD1003

Number of subjects included in analysis

126

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.7713

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Secondary: Mean change of the Nine Hole Peg Test (9HPT) between M0 and M24 (worst hand)

Top of page

End point title

Mean change of the Nine Hole Peg Test (9HPT) between M0 and M24 (worst hand)

End point description

End point type

Secondary

End point timeframe

M0-M24

End point values	MD1003-MD1003	Placebo-MD1003
Number of subjects analysed	90	40
Units: 9HPT score
arithmetic mean (standard deviation)	8.87 ± 33.86	7.70 ± 32.17

Mann-Whitney's U test

Comparison groups

MD1003-MD1003 v Placebo-MD1003

Number of subjects included in analysis

130

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.7694

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Secondary: Mean change in sub-score of the Kurtzke functional score between M0 and M12 (brain stem)

Top of page

End point title

Mean change in sub-score of the Kurtzke functional score between M0 and M12 (brain stem)

End point description

End point type

Secondary

End point timeframe

M0-M12

End point values	MD1003	Placebo
Number of subjects analysed	103	51
Units: Kurtzke fonctionnal score
arithmetic mean (standard deviation)	0.10 ± 0.69	-0.08 ± 0.82

Mann-Whitney's U test

Comparison groups

MD1003 v Placebo

Number of subjects included in analysis

154

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.1912

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Secondary: Mean change in sub-score of the Kurtzke functional score between M0 and M12 (pyramidal)

Top of page

End point title

Mean change in sub-score of the Kurtzke functional score between M0 and M12 (pyramidal)

End point description

End point type

Secondary

End point timeframe

M0-M12

End point values	MD1003	Placebo
Number of subjects analysed	103	51
Units: Kurztke fonctionnal score
arithmetic mean (standard deviation)	-0.03 ± 0.55	0.04 ± 0.53

Mann-Whitney's U test

Comparison groups

MD1003 v Placebo

Number of subjects included in analysis

154

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.5404

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Secondary: Mean change in sub-score of the Kurtzke functional score between M0 and M12 (cerebellar)

Top of page

End point title

Mean change in sub-score of the Kurtzke functional score between M0 and M12 (cerebellar)

End point description

End point type

Secondary

End point timeframe

M0-M12

End point values	MD1003	Placebo
Number of subjects analysed	101	49
Units: Kurtzke fonctionnal score
arithmetic mean (standard deviation)	0.19 ± 0.86	0.14 ± 1.12

Mann-Whitney's U test

Comparison groups

MD1003 v Placebo

Number of subjects included in analysis

150

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.5376

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Secondary: Mean change in sub-score of the Kurtzke functional score between M0 and M12 (sensory)

Top of page

End point title

Mean change in sub-score of the Kurtzke functional score between M0 and M12 (sensory)

End point description

End point type

Secondary

End point timeframe

M0-M12

End point values	MD1003	Placebo
Number of subjects analysed	103	51
Units: Kurtzke fonctionnal score
arithmetic mean (standard deviation)	-0.25 ± 0.93	0.06 ± 0.88

Mann-Whitney's U test

Comparison groups

MD1003 v Placebo

Number of subjects included in analysis

154

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.0896

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Secondary: Mean change in sub-score of the Kurtzke functional score between M0 and M12 (bowel and bladder)

Top of page

End point title

Mean change in sub-score of the Kurtzke functional score between M0 and M12 (bowel and bladder)

End point description

End point type

Secondary

End point timeframe

M0-M12

End point values	MD1003	Placebo
Number of subjects analysed	103	51
Units: Kurtzke fonctionnal score
arithmetic mean (standard deviation)	0.14 ± 0.83	0.20 ± 0.98

Mann-Whitney's U test

Comparison groups

Placebo v MD1003

Number of subjects included in analysis

154

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.6801

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Secondary: Mean change in sub-score of the Kurtzke functional score between M0 and M12 (cerebral)

Top of page

End point title

Mean change in sub-score of the Kurtzke functional score between M0 and M12 (cerebral)

End point description

End point type

Secondary

End point timeframe

M0-M12

End point values	MD1003	Placebo
Number of subjects analysed	103	51
Units: Kurtzke fonctionnal score
arithmetic mean (standard deviation)	-0.08 ± 0.76	0.08 ± 0.91

Mann-Whitney's U test

Comparison groups

MD1003 v Placebo

Number of subjects included in analysis

154

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.2619

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Secondary: Mean change in sub-score of the Kurtzke functional score between M0 and M24 (visual)

Top of page

End point title

Mean change in sub-score of the Kurtzke functional score between M0 and M24 (visual)

End point description

End point type

Secondary

End point timeframe

M0-M24

End point values	MD1003-MD1003	Placebo-MD1003
Number of subjects analysed	91	42
Units: Kurtzke fonctionnal score
arithmetic mean (standard deviation)	0.04 ± 1	0.17 ± 1.19

Mann-Whitney's U test

Comparison groups

MD1003-MD1003 v Placebo-MD1003

Number of subjects included in analysis

133

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.7312

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Secondary: Mean change in sub-score of the Kurtzke functional score between M0 and M24 (brain stem)

Top of page

End point title

Mean change in sub-score of the Kurtzke functional score between M0 and M24 (brain stem)

End point description

End point type

Secondary

End point timeframe

M0-M24

End point values	MD1003-MD1003	Placebo-MD1003
Number of subjects analysed	91	42
Units: Kurtzke fonctionnal score
arithmetic mean (standard deviation)	0.09 ± 0.89	0.14 ± 0.84

Mann-Whitney's U test

Comparison groups

MD1003-MD1003 v Placebo-MD1003

Number of subjects included in analysis

133

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.5761

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Secondary: Mean change in sub-score of the Kurtzke functional score between M0 and M24 (pyramidal)

Top of page

End point title

Mean change in sub-score of the Kurtzke functional score between M0 and M24 (pyramidal)

End point description

End point type

Secondary

End point timeframe

M0-M24

End point values	MD1003-MD1003	Placebo-MD1003
Number of subjects analysed	91	42
Units: Kurtzke fonctionnal score
arithmetic mean (standard deviation)	0.12 ± 0.61	0.12 ± 0.59

Mann-Whitney’s U test

Comparison groups

MD1003-MD1003 v Placebo-MD1003

Number of subjects included in analysis

133

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.878

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Secondary: Mean change in sub-score of the Kurtzke functional score between M0 and M24 (cerebellar)

Top of page

End point title

Mean change in sub-score of the Kurtzke functional score between M0 and M24 (cerebellar)

End point description

End point type

Secondary

End point timeframe

M0-M24

End point values	MD1003-MD1003	Placebo-MD1003
Number of subjects analysed	89	41
Units: Kurtzke fonctionnal score
arithmetic mean (standard deviation)	0.09 ± 0.91	0.05 ± 1.53

Mann-Whitney's U test

Comparison groups

MD1003-MD1003 v Placebo-MD1003

Number of subjects included in analysis

130

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.8181

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Secondary: Mean change in sub-score of the Kurtzke functional score between M0 and M24 (sensory)

Top of page

End point title

Mean change in sub-score of the Kurtzke functional score between M0 and M24 (sensory)

End point description

End point type

Secondary

End point timeframe

M0-M24

End point values	MD1003-MD1003	Placebo-MD1003
Number of subjects analysed	91	42
Units: Kurtzke fonctionnal score
arithmetic mean (standard deviation)	-0.08 ± 0.96	-0.17 ± 0.99

Mann-Whitney's U test

Comparison groups

MD1003-MD1003 v Placebo-MD1003

Number of subjects included in analysis

133

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.6394

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Secondary: Mean change in sub-score of the Kurtzke functional score between M0 and M24 (bowel and bladder)

Top of page

End point title

Mean change in sub-score of the Kurtzke functional score between M0 and M24 (bowel and bladder)

End point description

End point type

Secondary

End point timeframe

M0-M24

End point values	MD1003-MD1003	Placebo-MD1003
Number of subjects analysed	91	42
Units: Kurtzke fonctionnal score
arithmetic mean (standard deviation)	0.12 ± 0.89	0.02 ± 0.92

Mann-Whitney's U test

Comparison groups

MD1003-MD1003 v Placebo-MD1003

Number of subjects included in analysis

133

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.8062

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Secondary: Mean change in sub-score of the Kurtzke functional score between M0 and M24 (cerebral)

Top of page

End point title

Mean change in sub-score of the Kurtzke functional score between M0 and M24 (cerebral)

End point description

End point type

Secondary

End point timeframe

M0-M24

End point values	MD1003-MD1003	Placebo-MD1003
Number of subjects analysed	91	42
Units: Kurtzke fonctionnal score
arithmetic mean (standard deviation)	-0.01 ± 0.89	0 ± 0.96

Mann-Whitney's U test

Comparison groups

MD1003-MD1003 v Placebo-MD1003

Number of subjects included in analysis

133

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.7453

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Secondary: Mean change in sub-score of the Kurtzke functional score between M0 and M36 (visual)

Top of page

End point title

Mean change in sub-score of the Kurtzke functional score between M0 and M36 (visual)

End point description

End point type

Secondary

End point timeframe

M0-M36

End point values	MD1003-MD1003	Placebo-MD1003
Number of subjects analysed	91	42
Units: Kurtzke fonctionnal score
arithmetic mean (standard deviation)	0.03 ± 1.08	0.12 ± 1.15

Mann-Whitney's U test

Comparison groups

Placebo-MD1003 v MD1003-MD1003

Number of subjects included in analysis

133

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.921

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Secondary: Mean change in sub-score of the Kurtzke functional score between M0 and M36 (brain stem)

Top of page

End point title

Mean change in sub-score of the Kurtzke functional score between M0 and M36 (brain stem)

End point description

End point type

Secondary

End point timeframe

M0-M36

End point values	MD1003-MD1003	Placebo-MD1003
Number of subjects analysed	91	42
Units: Kurtzke fonctionnal score
arithmetic mean (standard deviation)	0.08 ± 0.91	0 ± 0.83

Mann-Whitney's U test

Comparison groups

MD1003-MD1003 v Placebo-MD1003

Number of subjects included in analysis

133

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.8211

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Secondary: Mean change in sub-score of the Kurtzke functional score between M0 and M36 (pyramidal)

Top of page

End point title

Mean change in sub-score of the Kurtzke functional score between M0 and M36 (pyramidal)

End point description

End point type

Secondary

End point timeframe

M0-M36

End point values	MD1003-MD1003	Placebo-MD1003
Number of subjects analysed	91	42
Units: Kurtzke fonctionnal score
arithmetic mean (standard deviation)	0.16 ± 0.75	0.19 ± 0.74

Mann-Whitney's U test

Comparison groups

MD1003-MD1003 v Placebo-MD1003

Number of subjects included in analysis

133

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.7737

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Secondary: Mean change in sub-score of the Kurtzke functional score between M0 and M36 (cerebellar)

Top of page

End point title

Mean change in sub-score of the Kurtzke functional score between M0 and M36 (cerebellar)

End point description

End point type

Secondary

End point timeframe

M0-M36

End point values	MD1003-MD1003	Placebo-MD1003
Number of subjects analysed	89	41
Units: Kurtzke fonctionnal score
arithmetic mean (standard deviation)	0.13 ± 1.04	0.22 ± 1.37

Mann-Whitney's U test

Comparison groups

MD1003-MD1003 v Placebo-MD1003

Number of subjects included in analysis

130

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.8437

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Secondary: Mean change in sub-score of the Kurtzke functional score between M0 and M36 (sensory)

Top of page

End point title

Mean change in sub-score of the Kurtzke functional score between M0 and M36 (sensory)

End point description

End point type

Secondary

End point timeframe

M0-M36

End point values	MD1003-MD1003	Placebo-MD1003
Number of subjects analysed	91	42
Units: Kurtzke fonctionnal score
arithmetic mean (standard deviation)	-0.16 ± 0.93	-0.02 ± 1

Mann-Whitney's U test

Comparison groups

Placebo-MD1003 v MD1003-MD1003

Number of subjects included in analysis

133

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.4809

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Secondary: Mean change in sub-score of the Kurtzke functional score between M0 and M36 (bowel and bladder)

Top of page

End point title

Mean change in sub-score of the Kurtzke functional score between M0 and M36 (bowel and bladder)

End point description

End point type

Secondary

End point timeframe

M0-M36

End point values	MD1003-MD1003	Placebo-MD1003
Number of subjects analysed	91	42
Units: Kurtzke fonctionnal score
arithmetic mean (standard deviation)	0.13 ± 0.96	0.19 ± 0.97

Mann-Whitney's U test

Comparison groups

MD1003-MD1003 v Placebo-MD1003

Number of subjects included in analysis

133

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.5514

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Secondary: Mean change in sub-score of the Kurtzke functional score between M0 and M36 (cerebral)

Top of page

End point title

Mean change in sub-score of the Kurtzke functional score between M0 and M36 (cerebral)

End point description

End point type

Secondary

End point timeframe

M0-M36

End point values	MD1003-MD1003	Placebo-MD1003
Number of subjects analysed	91	42
Units: Kurtzke fonctionnal score
arithmetic mean (standard deviation)	-0.03 ± 0.87	0.07 ± 0.92

Mann-Whitney's U test

Comparison groups

MD1003-MD1003 v Placebo-MD1003

Number of subjects included in analysis

133

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.5806

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Secondary: Mean change in sub-score of the Kurtzke functional score between M0 and M48 (visual)

Top of page

End point title

Mean change in sub-score of the Kurtzke functional score between M0 and M48 (visual)

End point description

End point type

Secondary

End point timeframe

M0-M48

End point values	MD1003-MD1003	Placebo-MD1003
Number of subjects analysed	91	42
Units: Kurtzke fonctionnal score
arithmetic mean (standard deviation)	0.03 ± 1.06	-0.1 ± 0.73

Mann-Whitney's U test

Comparison groups

MD1003-MD1003 v Placebo-MD1003

Number of subjects included in analysis

133

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.4782

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Secondary: Mean change in sub-score of the Kurtzke functional score between M0 and M48 (brain stem)

Top of page

End point title

Mean change in sub-score of the Kurtzke functional score between M0 and M48 (brain stem)

End point description

End point type

Secondary

End point timeframe

M0-M48

End point values	MD1003-MD1003	Placebo-MD1003
Number of subjects analysed	91	42
Units: kurtzke fonctionnal score
arithmetic mean (standard deviation)	0.14 ± 0.88	0.05 ± 0.85

Mann-Whitney's U test

Comparison groups

MD1003-MD1003 v Placebo-MD1003

Number of subjects included in analysis

133

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.8818

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Secondary: Mean change in sub-score of the Kurtzke functional score between M0 and M48 (pyramidal)

Top of page

End point title

Mean change in sub-score of the Kurtzke functional score between M0 and M48 (pyramidal)

End point description

End point type

Secondary

End point timeframe

M0-M48

End point values	MD1003-MD1003	Placebo-MD1003
Number of subjects analysed	91	42
Units: Kurtzke fonctionnal score
arithmetic mean (standard deviation)	0.21 ± 0.77	0.26 ± 0.83

Mann-Whitney's U test

Comparison groups

MD1003-MD1003 v Placebo-MD1003

Number of subjects included in analysis

133

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.7643

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Secondary: Mean change in sub-score of the Kurtzke functional score between M0 and M48 (cerebellar)

Top of page

End point title

Mean change in sub-score of the Kurtzke functional score between M0 and M48 (cerebellar)

End point description

End point type

Secondary

End point timeframe

M0-M48

End point values	MD1003-MD1003	Placebo-MD1003
Number of subjects analysed	89	41
Units: Kurtzke fonctionnal score
arithmetic mean (standard deviation)	0.18 ± 1.05	0.12 ± 1.5

Mann-Whitney's U test

Comparison groups

MD1003-MD1003 v Placebo-MD1003

Number of subjects included in analysis

130

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.8652

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Secondary: Mean change in sub-score of the Kurtzke functional score between M0 and M48 (sensory)

Top of page

End point title

Mean change in sub-score of the Kurtzke functional score between M0 and M48 (sensory)

End point description

End point type

Secondary

End point timeframe

M0-M48

End point values	MD1003-MD1003	Placebo-MD1003
Number of subjects analysed	91	42
Units: Kurtzke fonctionnal score
arithmetic mean (standard deviation)	-0.11 ± 1	0.12 ± 0.97

Mann-Whitney's U test

Comparison groups

MD1003-MD1003 v Placebo-MD1003

Number of subjects included in analysis

133

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.2847

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Secondary: Mean change in sub-score of the Kurtzke functional score between M0 and M48 (bowel and bladder)

Top of page

End point title

Mean change in sub-score of the Kurtzke functional score between M0 and M48 (bowel and bladder)

End point description

End point type

Secondary

End point timeframe

M0-M48

End point values	MD1003-MD1003	Placebo-MD1003
Number of subjects analysed	91	42
Units: Kurtzke fonctionnal score
arithmetic mean (standard deviation)	0.1 ± 0.98	0.26 ± 0.94

Mann-Whitney's U test

Comparison groups

MD1003-MD1003 v Placebo-MD1003

Number of subjects included in analysis

133

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.2531

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Secondary: Mean change in sub-score of the Kurtzke functional score between M0 and M48 (cerebral)

Top of page

End point title

Mean change in sub-score of the Kurtzke functional score between M0 and M48 (cerebral)

End point description

End point type

Secondary

End point timeframe

M0-M48

End point values	MD1003-MD1003	Placebo-MD1003
Number of subjects analysed	91	42
Units: Kurtzke fonctionnal score
arithmetic mean (standard deviation)	0.02 ± 1.05	0.1 ± 0.93

Mann-Whitney's U test

Comparison groups

MD1003-MD1003 v Placebo-MD1003

Number of subjects included in analysis

133

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.4569

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Secondary: Mean change in sub-score of the Kurtzke functional score between M0 and M60 (visual)

Top of page

End point title

Mean change in sub-score of the Kurtzke functional score between M0 and M60 (visual)

End point description

End point type

Secondary

End point timeframe

M0-M60

End point values	MD1003-MD1003	Placebo-MD1003
Number of subjects analysed	91	42
Units: Kurtzke fonctionnal score
arithmetic mean (standard deviation)	0.05 ± 1.07	-0.07 ± 0.81

Mann-Whitney's U test

Comparison groups

MD1003-MD1003 v Placebo-MD1003

Number of subjects included in analysis

133

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.4438

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Secondary: Mean change in sub-score of the Kurtzke functional score between M0 and M60 (brain stem)

Top of page

End point title

Mean change in sub-score of the Kurtzke functional score between M0 and M60 (brain stem)

End point description

End point type

Secondary

End point timeframe

M0-M60

End point values	MD1003-MD1003	Placebo-MD1003
Number of subjects analysed	91	42
Units: Kurtzke fonctionnal score
arithmetic mean (standard deviation)	0.12 ± 0.88	0.05 ± 0.88

Mann-Whitney's U test

Comparison groups

MD1003-MD1003 v Placebo-MD1003

Number of subjects included in analysis

133

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.8021

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Secondary: Mean change in sub-score of the Kurtzke functional score between M0 and M60 (pyramidal)

Top of page

End point title

Mean change in sub-score of the Kurtzke functional score between M0 and M60 (pyramidal)

End point description

End point type

Secondary

End point timeframe

M0-M60

End point values	MD1003-MD1003	Placebo-MD1003
Number of subjects analysed	91	42
Units: Kurtzke fonctionnal score
arithmetic mean (standard deviation)	0.22 ± 0.73	0.26 ± 0.8

Mann-Whitney's U test

Comparison groups

MD1003-MD1003 v Placebo-MD1003

Number of subjects included in analysis

133

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.664

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Secondary: Mean change in sub-score of the Kurtzke functional score between M0 and M60 (cerebellar)

Top of page

End point title

Mean change in sub-score of the Kurtzke functional score between M0 and M60 (cerebellar)

End point description

End point type

Secondary

End point timeframe

M0-M60

End point values	MD1003-MD1003	Placebo-MD1003
Number of subjects analysed	89	41
Units: Kurtzke fonctionnal score
arithmetic mean (standard deviation)	0.16 ± 1.09	0.12 ± 1.5

Mann-Whitney's U test

Comparison groups

Placebo-MD1003 v MD1003-MD1003

Number of subjects included in analysis

130

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.7363

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Secondary: Mean change in sub-score of the Kurtzke functional score between M0 and M60 (sensory)

Top of page

End point title

Mean change in sub-score of the Kurtzke functional score between M0 and M60 (sensory)

End point description

End point type

Secondary

End point timeframe

M0-M60

End point values	MD1003-MD1003	Placebo-MD1003
Number of subjects analysed	91	42
Units: Kurtzke fonctionnal score
arithmetic mean (standard deviation)	-0.09 ± 1.03	0.12 ± 0.99

Mann-Whitney's U test

Comparison groups

MD1003-MD1003 v Placebo-MD1003

Number of subjects included in analysis

133

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.2937

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Secondary: Mean change in sub-score of the Kurtzke functional score between M0 and M60 (bowel and bladder)

Top of page

End point title

Mean change in sub-score of the Kurtzke functional score between M0 and M60 (bowel and bladder)

End point description

End point type

Secondary

End point timeframe

M0-M60

End point values	MD1003-MD1003	Placebo-MD1003
Number of subjects analysed	91	42
Units: Kurtzke fonctionnal score
arithmetic mean (standard deviation)	0.25 ± 1.08	0.24 ± 0.93

Mann-Whitney's U test

Comparison groups

MD1003-MD1003 v Placebo-MD1003

Number of subjects included in analysis

133

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.8206

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Secondary: Mean change in sub-score of the Kurtzke functional score between M0 and M60 (cerebral)

Top of page

End point title

Mean change in sub-score of the Kurtzke functional score between M0 and M60 (cerebral)

End point description

End point type

Secondary

End point timeframe

M0-M60

End point values	MD1003-MD1003	Placebo-MD1003
Number of subjects analysed	91	42
Units: Kurtzke fonctionnal score
arithmetic mean (standard deviation)	-0.01 ± 0.9	-0.02 ± 0.95

Mann-Whitney's U test

Comparison groups

Placebo-MD1003 v MD1003-MD1003

Number of subjects included in analysis

133

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.9151

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Adverse events

Top of page

Timeframe for reporting adverse events

From ICF signature to M84

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

Reporting group title

MD1003

Reporting group description

Reporting group title

Placebo

Reporting group description

Reporting group title

MD1003-MD1003 extension phase

Reporting group description

Reporting group title

Placebo-MD1003 extension phase

Reporting group description

Serious adverse events	MD1003	Placebo	MD1003-MD1003 extension phase	Placebo-MD1003 extension phase
Total subjects affected by serious adverse events
subjects affected / exposed	21 / 103 (20.39%)	12 / 51 (23.53%)	32 / 91 (35.16%)	16 / 42 (38.10%)
number of deaths (all causes)	1	0	1	0
number of deaths resulting from adverse events	0	0	0	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
subjects affected / exposed	0 / 103 (0.00%)	0 / 51 (0.00%)	1 / 91 (1.10%)	1 / 42 (2.38%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Rectal cancer
subjects affected / exposed	0 / 103 (0.00%)	0 / 51 (0.00%)	1 / 91 (1.10%)	0 / 42 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Vascular disorders
Deep vein thrombosis
subjects affected / exposed	0 / 103 (0.00%)	0 / 51 (0.00%)	1 / 91 (1.10%)	0 / 42 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Phlebitis
subjects affected / exposed	0 / 103 (0.00%)	0 / 51 (0.00%)	0 / 91 (0.00%)	1 / 42 (2.38%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Surgical and medical procedures
Cholecystectomy
subjects affected / exposed	0 / 103 (0.00%)	1 / 51 (1.96%)	0 / 91 (0.00%)	0 / 42 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Gamma radiation therapy to brain
subjects affected / exposed	1 / 103 (0.97%)	0 / 51 (0.00%)	0 / 91 (0.00%)	0 / 42 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Hospitalisation
subjects affected / exposed	1 / 103 (0.97%)	0 / 51 (0.00%)	0 / 91 (0.00%)	0 / 42 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac ablation
subjects affected / exposed	0 / 103 (0.00%)	0 / 51 (0.00%)	1 / 91 (1.10%)	0 / 42 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Hip arthroplasty
subjects affected / exposed	0 / 103 (0.00%)	0 / 51 (0.00%)	0 / 91 (0.00%)	1 / 42 (2.38%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Intrathecal pump insertion
subjects affected / exposed	0 / 103 (0.00%)	0 / 51 (0.00%)	0 / 91 (0.00%)	1 / 42 (2.38%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Rehabilitation therapy
subjects affected / exposed	0 / 103 (0.00%)	0 / 51 (0.00%)	1 / 91 (1.10%)	0 / 42 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Urinary cystectomy
subjects affected / exposed	0 / 103 (0.00%)	0 / 51 (0.00%)	1 / 91 (1.10%)	0 / 42 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Urostomy
subjects affected / exposed	0 / 103 (0.00%)	0 / 51 (0.00%)	1 / 91 (1.10%)	0 / 42 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
General disorders and administration site conditions
Condition aggravated
subjects affected / exposed	0 / 103 (0.00%)	0 / 51 (0.00%)	1 / 91 (1.10%)	1 / 42 (2.38%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
General physical health deterioration
subjects affected / exposed	0 / 103 (0.00%)	0 / 51 (0.00%)	1 / 91 (1.10%)	2 / 42 (4.76%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Reproductive system and breast disorders
Breast mass
subjects affected / exposed	0 / 103 (0.00%)	0 / 51 (0.00%)	1 / 91 (1.10%)	0 / 42 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Prostatitis
subjects affected / exposed	0 / 103 (0.00%)	0 / 51 (0.00%)	0 / 91 (0.00%)	1 / 42 (2.38%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Asthmatic crisis
subjects affected / exposed	0 / 103 (0.00%)	0 / 51 (0.00%)	1 / 91 (1.10%)	0 / 42 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Lung disorder
subjects affected / exposed	0 / 103 (0.00%)	0 / 51 (0.00%)	1 / 91 (1.10%)	0 / 42 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pulmonary embolism
subjects affected / exposed	0 / 103 (0.00%)	0 / 51 (0.00%)	1 / 91 (1.10%)	1 / 42 (2.38%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Psychiatric disorders
Completed suicide
subjects affected / exposed	1 / 103 (0.97%)	0 / 51 (0.00%)	0 / 91 (0.00%)	0 / 42 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
Mental disorder
subjects affected / exposed	0 / 103 (0.00%)	1 / 51 (1.96%)	0 / 91 (0.00%)	0 / 42 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Suicide attempt
subjects affected / exposed	0 / 103 (0.00%)	0 / 51 (0.00%)	1 / 91 (1.10%)	0 / 42 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Investigations
Inflammatory marker increased
subjects affected / exposed	0 / 103 (0.00%)	0 / 51 (0.00%)	1 / 91 (1.10%)	0 / 42 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Laboratory test interference
subjects affected / exposed	0 / 103 (0.00%)	0 / 51 (0.00%)	0 / 91 (0.00%)	1 / 42 (2.38%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Weight decreased
subjects affected / exposed	0 / 103 (0.00%)	0 / 51 (0.00%)	1 / 91 (1.10%)	0 / 42 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Injury, poisoning and procedural complications
Fibula fracture
subjects affected / exposed	0 / 103 (0.00%)	1 / 51 (1.96%)	0 / 91 (0.00%)	0 / 42 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Humerus fracture
subjects affected / exposed	1 / 103 (0.97%)	0 / 51 (0.00%)	1 / 91 (1.10%)	0 / 42 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Overdose
subjects affected / exposed	0 / 103 (0.00%)	1 / 51 (1.96%)	0 / 91 (0.00%)	0 / 42 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Tibia fracture
subjects affected / exposed	0 / 103 (0.00%)	1 / 51 (1.96%)	0 / 91 (0.00%)	0 / 42 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Wrist fracture
subjects affected / exposed	1 / 103 (0.97%)	0 / 51 (0.00%)	1 / 91 (1.10%)	0 / 42 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Clavicle fracture
subjects affected / exposed	0 / 103 (0.00%)	0 / 51 (0.00%)	1 / 91 (1.10%)	0 / 42 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Femoral neck fracture
subjects affected / exposed	0 / 103 (0.00%)	0 / 51 (0.00%)	0 / 91 (0.00%)	1 / 42 (2.38%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Fractured sacrum
subjects affected / exposed	0 / 103 (0.00%)	0 / 51 (0.00%)	0 / 91 (0.00%)	1 / 42 (2.38%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Hip fracture
subjects affected / exposed	0 / 103 (0.00%)	0 / 51 (0.00%)	0 / 91 (0.00%)	1 / 42 (2.38%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Lower limb fracture
subjects affected / exposed	0 / 103 (0.00%)	0 / 51 (0.00%)	1 / 91 (1.10%)	0 / 42 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pelvic fracture
subjects affected / exposed	0 / 103 (0.00%)	0 / 51 (0.00%)	0 / 91 (0.00%)	1 / 42 (2.38%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Radiation necrosis
subjects affected / exposed	0 / 103 (0.00%)	0 / 51 (0.00%)	1 / 91 (1.10%)	0 / 42 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Spinal fracture
subjects affected / exposed	0 / 103 (0.00%)	0 / 51 (0.00%)	0 / 91 (0.00%)	1 / 42 (2.38%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac disorders
Supraventricular tachycardia
subjects affected / exposed	1 / 103 (0.97%)	0 / 51 (0.00%)	1 / 91 (1.10%)	0 / 42 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Myocardial infarction
subjects affected / exposed	0 / 103 (0.00%)	0 / 51 (0.00%)	0 / 91 (0.00%)	1 / 42 (2.38%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Nervous system disorders
Haemorrhage intracranial
subjects affected / exposed	0 / 103 (0.00%)	1 / 51 (1.96%)	0 / 91 (0.00%)	0 / 42 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Multiple sclerosis
subjects affected / exposed	1 / 103 (0.97%)	1 / 51 (1.96%)	4 / 91 (4.40%)	3 / 42 (7.14%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 5	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Multiple sclerosis relapse
subjects affected / exposed	6 / 103 (5.83%)	4 / 51 (7.84%)	11 / 91 (12.09%)	5 / 42 (11.90%)
occurrences causally related to treatment / all	0 / 8	0 / 4	5 / 16	1 / 7
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Muscle spasticity
subjects affected / exposed	1 / 103 (0.97%)	0 / 51 (0.00%)	0 / 91 (0.00%)	0 / 42 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Cerebrovascular accident
subjects affected / exposed	0 / 103 (0.00%)	0 / 51 (0.00%)	1 / 91 (1.10%)	0 / 42 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
Epilepsy
subjects affected / exposed	0 / 103 (0.00%)	0 / 51 (0.00%)	1 / 91 (1.10%)	0 / 42 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Nervous system disorder
subjects affected / exposed	0 / 103 (0.00%)	0 / 51 (0.00%)	1 / 91 (1.10%)	0 / 42 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Trigeminal neuralgia
subjects affected / exposed	0 / 103 (0.00%)	0 / 51 (0.00%)	1 / 91 (1.10%)	0 / 42 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Uhthoff's phenomenon
subjects affected / exposed	0 / 103 (0.00%)	0 / 51 (0.00%)	1 / 91 (1.10%)	0 / 42 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Blood and lymphatic system disorders
Anaemia
subjects affected / exposed	0 / 103 (0.00%)	0 / 51 (0.00%)	1 / 91 (1.10%)	0 / 42 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Immune thrombocytopenia
subjects affected / exposed	0 / 103 (0.00%)	0 / 51 (0.00%)	0 / 91 (0.00%)	1 / 42 (2.38%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
Abdominal pain
subjects affected / exposed	0 / 103 (0.00%)	1 / 51 (1.96%)	1 / 91 (1.10%)	0 / 42 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Diarrhoea
subjects affected / exposed	1 / 103 (0.97%)	0 / 51 (0.00%)	0 / 91 (0.00%)	0 / 42 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Duodenitis
subjects affected / exposed	1 / 103 (0.97%)	0 / 51 (0.00%)	0 / 91 (0.00%)	0 / 42 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Inguinal hernia
subjects affected / exposed	0 / 103 (0.00%)	0 / 51 (0.00%)	1 / 91 (1.10%)	0 / 42 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Intestinal obstruction
subjects affected / exposed	0 / 103 (0.00%)	0 / 51 (0.00%)	1 / 91 (1.10%)	0 / 42 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Hepatobiliary disorders
Cholecystitis acute
subjects affected / exposed	1 / 103 (0.97%)	0 / 51 (0.00%)	0 / 91 (0.00%)	0 / 42 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
Mucocutaneous rash
subjects affected / exposed	1 / 103 (0.97%)	0 / 51 (0.00%)	0 / 91 (0.00%)	0 / 42 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Renal and urinary disorders
Urinary retention
subjects affected / exposed	0 / 103 (0.00%)	1 / 51 (1.96%)	0 / 91 (0.00%)	0 / 42 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Urinary tract disorder
subjects affected / exposed	0 / 103 (0.00%)	0 / 51 (0.00%)	1 / 91 (1.10%)	0 / 42 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Endocrine disorders
Goitre
subjects affected / exposed	1 / 103 (0.97%)	0 / 51 (0.00%)	0 / 91 (0.00%)	0 / 42 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Myopathy
subjects affected / exposed	0 / 103 (0.00%)	0 / 51 (0.00%)	0 / 91 (0.00%)	1 / 42 (2.38%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Infections and infestations
Enterocolitis infectious
subjects affected / exposed	1 / 103 (0.97%)	0 / 51 (0.00%)	0 / 91 (0.00%)	0 / 42 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Erysipelas
subjects affected / exposed	1 / 103 (0.97%)	0 / 51 (0.00%)	0 / 91 (0.00%)	1 / 42 (2.38%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Urinary tract infection
subjects affected / exposed	1 / 103 (0.97%)	0 / 51 (0.00%)	1 / 91 (1.10%)	2 / 42 (4.76%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Bursitis infective staphylococcal
subjects affected / exposed	0 / 103 (0.00%)	0 / 51 (0.00%)	1 / 91 (1.10%)	0 / 42 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Gastroenteritis
subjects affected / exposed	0 / 103 (0.00%)	0 / 51 (0.00%)	1 / 91 (1.10%)	0 / 42 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Viral infection
subjects affected / exposed	0 / 103 (0.00%)	0 / 51 (0.00%)	1 / 91 (1.10%)	0 / 42 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Metabolism and nutrition disorders
Hypercalcaemia
subjects affected / exposed	0 / 103 (0.00%)	0 / 51 (0.00%)	0 / 91 (0.00%)	1 / 42 (2.38%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Hypoglycaemia
subjects affected / exposed	0 / 103 (0.00%)	0 / 51 (0.00%)	1 / 91 (1.10%)	0 / 42 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	MD1003	Placebo	MD1003-MD1003 extension phase	Placebo-MD1003 extension phase
Total subjects affected by non serious adverse events
subjects affected / exposed	21 / 103 (20.39%)	13 / 51 (25.49%)	78 / 91 (85.71%)	38 / 42 (90.48%)
Injury, poisoning and procedural complications
Fall
subjects affected / exposed	0 / 103 (0.00%)	0 / 51 (0.00%)	5 / 91 (5.49%)	2 / 42 (4.76%)
occurrences all number	0	0	5	2
Vascular disorders
Hypertension
subjects affected / exposed	0 / 103 (0.00%)	0 / 51 (0.00%)	2 / 91 (2.20%)	3 / 42 (7.14%)
occurrences all number	0	0	2	3
Cardiac disorders
Oedema peripheral
subjects affected / exposed	0 / 103 (0.00%)	0 / 51 (0.00%)	8 / 91 (8.79%)	0 / 42 (0.00%)
occurrences all number	0	0	9	0
Nervous system disorders
Multiple sclerosis relapse
subjects affected / exposed	6 / 103 (5.83%)	4 / 51 (7.84%)	14 / 91 (15.38%)	6 / 42 (14.29%)
occurrences all number	8	4	21	9
Headache
subjects affected / exposed	4 / 103 (3.88%)	3 / 51 (5.88%)	0 / 91 (0.00%)	0 / 42 (0.00%)
occurrences all number	5	7	0	0
General disorders and administration site conditions
Back pain
subjects affected / exposed	4 / 103 (3.88%)	3 / 51 (5.88%)	6 / 91 (6.59%)	3 / 42 (7.14%)
occurrences all number	4	3	6	3
Fatigue
subjects affected / exposed	1 / 103 (0.97%)	4 / 51 (7.84%)	0 / 91 (0.00%)	0 / 42 (0.00%)
occurrences all number	1	5	0	0
Asthenia
subjects affected / exposed	0 / 103 (0.00%)	0 / 51 (0.00%)	5 / 91 (5.49%)	2 / 42 (4.76%)
occurrences all number	0	0	6	2
Immune system disorders
Multiple sclerosis
subjects affected / exposed	12 / 103 (11.65%)	7 / 51 (13.73%)	9 / 91 (9.89%)	5 / 42 (11.90%)
occurrences all number	13	9	10	7
Gastrointestinal disorders
Diarrhoea
subjects affected / exposed	0 / 103 (0.00%)	0 / 51 (0.00%)	1 / 91 (1.10%)	3 / 42 (7.14%)
occurrences all number	0	0	1	4
Musculoskeletal and connective tissue disorders
Muscle spasticity
subjects affected / exposed	4 / 103 (3.88%)	6 / 51 (11.76%)	3 / 91 (3.30%)	3 / 42 (7.14%)
occurrences all number	4	7	3	3
Arthralgia
subjects affected / exposed	0 / 103 (0.00%)	0 / 51 (0.00%)	7 / 91 (7.69%)	2 / 42 (4.76%)
occurrences all number	0	0	7	2
Ligament sprain
subjects affected / exposed	0 / 103 (0.00%)	0 / 51 (0.00%)	5 / 91 (5.49%)	0 / 42 (0.00%)
occurrences all number	0	0	5	0
Osteoporosis
subjects affected / exposed	0 / 103 (0.00%)	0 / 51 (0.00%)	4 / 91 (4.40%)	3 / 42 (7.14%)
occurrences all number	0	0	4	3
Infections and infestations
Urinary tract infection
subjects affected / exposed	11 / 103 (10.68%)	6 / 51 (11.76%)	18 / 91 (19.78%)	11 / 42 (26.19%)
occurrences all number	13	9	33	24
Bronchitis
subjects affected / exposed	5 / 103 (4.85%)	6 / 51 (11.76%)	6 / 91 (6.59%)	4 / 42 (9.52%)
occurrences all number	5	6	7	4
Nasopharyngitis
subjects affected / exposed	5 / 103 (4.85%)	3 / 51 (5.88%)	5 / 91 (5.49%)	1 / 42 (2.38%)
occurrences all number	5	4	8	1
Influenza
subjects affected / exposed	0 / 103 (0.00%)	0 / 51 (0.00%)	5 / 91 (5.49%)	1 / 42 (2.38%)
occurrences all number	0	0	5	1
Influenza like illness
subjects affected / exposed	0 / 103 (0.00%)	0 / 51 (0.00%)	3 / 91 (3.30%)	3 / 42 (7.14%)
occurrences all number	0	0	4	3

More information

Top of page

Were there any global substantial amendments to the protocol? Yes

24 Sep 2013

I) Modification of the study design II) Addition of the ancillary study III) Modification of one of the non-inclusion criteria IV) Addition of a non inclusion criteria

22 Jan 2014

I) Modification of the primary endpoint II) Modification of the secondary endpoints III) Modification of the age inclusion crietria IV) Modification of a non inclusion criteria V) Deletion of the exclusion criteria VI) Creation of a Data and Safety Monitoring Board (DSMB) VII) Modification of the number of patients included in the study

02 May 2014

I) Clarification of the primary endpoint II) Addition of a secondary endpoint III) Addition of a homostasis assessment during and at the end of the study

06 Jun 2014

Clarification on the primary endpoint without any change on patients' safety

22 Jul 2014

Addition of a secondary endpoint

22 Jan 2015

I) Update of the investigator's brochure with new non clinical data having an impact on patients' safety and the trial protocol II) Update of the number of included patients III) Modification of the protocol according to new clinical and non clinical events IV) Modification of the protocol with addition of a brain MRI at M24 V) Clarification on the MRI follow up protocol and addition of new MRI analyses VI) Clarification on protocol for the interim analysis of the results related to the double blind 12-month period. VII) Modification of the patient information sheet following new clinical and non clinical events and clarification on the MRI follow up protocol with addition of new analyses of MRI data

07 Sep 2015

Extension of the follow-up period for the patients' cohort up to 3 year follow-up

15 Jun 2016

To increase the follow-up period of the patients' cohort, it is proposed to continue the study up to 4 year follow-up (until M48) + update of sponsor's contact details + update of investigators' list.

08 Jun 2017

In order to increase the duration of cohorts follow-up, it is proposed to continue the study until Marketing Authorisation is obtained, with visits every 6 months.

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

Clinical Trial Results: Effect of MD1003 in spinal progressive multiple sclerosis: a pivotal randomized double blind placebo controlled study

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Proportion of patients with improvement of either the EDSS or the TW25 at M9 confirmed at M12

Primary: Proportion of patients with improvement of either the EDSS or the TW25 at M9 confirmed at M12

Secondary: CGI score at M12

Secondary: CGI score at M12

Secondary: Proportions of patients with improvement of both EDSS and TW25 at M9 and confirmed at M12

Secondary: Proportions of patients with improvement of both EDSS and TW25 at M9 and confirmed at M12

Secondary: Proportion of patients with increased EDSS score at M9 and confirmed at M12

Secondary: Proportion of patients with increased EDSS score at M9 and confirmed at M12

Secondary: Proportion of patients with stable EDSS score at M9 and confirmed at M12

Secondary: Proportion of patients with stable EDSS score at M9 and confirmed at M12

Secondary: Mean change in General Health Sub-score of the SF36 questionnaire between M0 and M12

Secondary: Mean change in General Health Sub-score of the SF36 questionnaire between M0 and M12

Secondary: Mean change in the fatigue impact scale (M-FIS) between M0 and M12

Secondary: Mean change in the fatigue impact scale (M-FIS) between M0 and M12

Secondary: Mean change of the Nine Hole Peg Test (9HPT) between M0 and M12 (Best hand)

Secondary: Mean change of the Nine Hole Peg Test (9HPT) between M0 and M12 (Best hand)

Secondary: Mean change in sub-score of the Kurtzke functional score between M0 and M12 (visual)

Secondary: Mean change in sub-score of the Kurtzke functional score between M0 and M12 (visual)

Secondary: Mean change in EDSS between M0 and M18

Secondary: Mean change in EDSS between M0 and M18

Secondary: Mean change in EDSS between M0 and M24

Secondary: Mean change in EDSS between M0 and M24

Secondary: Mean change in EDSS between M0 and M30

Secondary: Mean change in EDSS between M0 and M30

Secondary: Mean change in EDSS between M0 and M36

Secondary: Mean change in EDSS between M0 and M36

Secondary: Mean change in EDSS between M0 and M42

Secondary: Mean change in EDSS between M0 and M42

Secondary: Mean change in EDSS between M0 and M48

Secondary: Mean change in EDSS between M0 and M48

Secondary: Mean change in EDSS between M0 and M54

Secondary: Mean change in EDSS between M0 and M54

Secondary: Mean change in EDSS between M0 and M60

Secondary: Mean change in EDSS between M0 and M60

Secondary: Mean change in the MS walking scale (MSWS) between M0 and M24

Secondary: Mean change in the MS walking scale (MSWS) between M0 and M24

Secondary: Mean change in the MS walking scale (MSWS) between M0 and M12

Secondary: Mean change in the MS walking scale (MSWS) between M0 and M12

Secondary: CGI score at M24

Secondary: CGI score at M24

Secondary: CGI score at M36

Secondary: CGI score at M36

Secondary: Mean percent change in TW25 between M0 and M12

Secondary: Mean percent change in TW25 between M0 and M12

Secondary: Mean percent change in TW25 between M0 and M24

Secondary: Mean percent change in TW25 between M0 and M24

Secondary: Mean percent change in TW25 between M0 and M36

Secondary: Mean percent change in TW25 between M0 and M36

Secondary: Proportions of patients with improvement of both EDSS and TW25 at M18 and confirmed at M24

Secondary: Proportions of patients with improvement of both EDSS and TW25 at M18 and confirmed at M24

Secondary: Proportions of patients with improvement of both EDSS and TW25 at M24 and confirmed at M30

Secondary: Proportions of patients with improvement of both EDSS and TW25 at M24 and confirmed at M30

Secondary: Proportions of patients with improvement of both EDSS and TW25 at M36 and confirmed at M42

Secondary: Proportions of patients with improvement of both EDSS and TW25 at M36 and confirmed at M42

Secondary: Proportions of patients with improvement of both EDSS and TW25 at M30 and confirmed at M36

Secondary: Proportions of patients with improvement of both EDSS and TW25 at M30 and confirmed at M36

Secondary: Proportions of patients with improvement of both EDSS and TW25 at M42 and confirmed at M48

Secondary: Proportions of patients with improvement of both EDSS and TW25 at M42 and confirmed at M48

Secondary: Proportions of patients with improvement of both EDSS and TW25 at M48 and confirmed at M54

Secondary: Proportions of patients with improvement of both EDSS and TW25 at M48 and confirmed at M54

Secondary: Proportion of patients with increased EDSS score at M18 confirmed at M24

Secondary: Proportion of patients with increased EDSS score at M18 confirmed at M24

Secondary: Proportion of patients with increased EDSS score at M12 and confirmed at M18

Secondary: Proportion of patients with increased EDSS score at M12 and confirmed at M18

Secondary: Proportion of patients with increased EDSS score at M24 and confirmed at M30

Secondary: Proportion of patients with increased EDSS score at M24 and confirmed at M30

Secondary: Proportion of patients with increased EDSS score at M30 and confirmed at M36

Secondary: Proportion of patients with increased EDSS score at M30 and confirmed at M36

Secondary: Proportion of patients with increased EDSS score at M36 and confirmed at M42

Secondary: Proportion of patients with increased EDSS score at M36 and confirmed at M42

Clinical Trial Results:
Effect of MD1003 in spinal progressive multiple sclerosis: a pivotal randomized double blind placebo controlled study