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Clinical Trial Results:
A phase III, multicentre, prospective, double blind, randomised, placebo controlled study, assessing the efficacy and safety of Dysport intramuscular injections used for the treatment of upper limb spasticity in adult subjects with spastic hemiparesis due to stroke or traumatic brain injury.

Summary
EudraCT number	2010-019069-28
Trial protocol	BE CZ SK PL IT HU
Global end of trial date	04 Sep 2013

Results information
Results version number	v1(current)
This version publication date	25 Mar 2016
First version publication date	25 Mar 2016
Other versions

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

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Trial information

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Sponsor protocol code

Y-52-52120-145

ISRCTN number

-

US NCT number

-

WHO universal trial number (UTN)

-

Sponsor organisation name

Ipsen Innovation

Sponsor organisation address

5 Avenue du Canada, Les Ulis, France, 91940

Public contact

Medical Director, Neurology, Ipsen Innovation, clinical.trials@ipsen.com

Scientific contact

Medical Director, Neurology., Ipsen Innovation, clinical.trials@ipsen.com

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

No

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

No

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

No

Analysis stage

Final

Date of interim/final analysis

17 Apr 2014

Is this the analysis of the primary completion data?

Yes

Primary completion date

04 Sep 2013

Global end of trial reached?

Yes

Global end of trial date

04 Sep 2013

Was the trial ended prematurely?

No

Main objective of the trial

The primary study objective is to assess the efficacy of Dysport compared to placebo in reducing upper limb muscle tone in hemiparetic subjects with upper limb spasticity due to stroke or traumatic brain injury. The primary study objective will be assessed by comparing between treatment groups at Week 4 the change from baseline in muscle tone (using the Modified Ashworth Scale (MAS)) in the primary targeted muscle group

Protection of trial subjects

This clinical study was designed and implemented and reported in accordance with the International Conference on Harmonization (ICH) Harmonized Tripartite Guidelines for Good Clinical Practice (GCP), with applicable local regulations (including European Directive 2001/20/EC, US Code of Federal Regulations Title 21, and Japanese Ministry of Health, Labor, and Welfare), and with the ethical principles laid down in the Declaration of Helsinki.

Background therapy

-

Evidence for comparator

-

Actual start date of recruitment

04 Aug 2011

Long term follow-up planned

No

Independent data monitoring committee (IDMC) involvement?

No

Number of subjects enrolled per country

Country: Number of subjects enrolled

Russian Federation: 22

Country: Number of subjects enrolled

United States: 95

Country: Number of subjects enrolled

Poland: 29

Country: Number of subjects enrolled

Slovakia: 11

Country: Number of subjects enrolled

Belgium: 15

Country: Number of subjects enrolled

Czech Republic: 22

Country: Number of subjects enrolled

France: 34

Country: Number of subjects enrolled

Hungary: 8

Country: Number of subjects enrolled

Italy: 7

Worldwide total number of subjects

243

EEA total number of subjects

126

Number of subjects enrolled per age group

In utero

0

Preterm newborn - gestational age < 37 wk

0

Newborns (0-27 days)

0

Infants and toddlers (28 days-23 months)

0

Children (2-11 years)

0

Adolescents (12-17 years)

0

Adults (18-64 years)

193

From 65 to 84 years

50

85 years and over

0

Subject disposition

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Recruitment details

This multi-center study was conducted in 34 investigation sites. Subjects screened were 281 and randomized and treated were 243.

Screening details

A total of 281 subjects were screened and 243 were randomised and treated into study.

Period 1 title

Randomized population (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Investigator, Subject, Assessor

Are arms mutually exclusive

Yes

Placebo

Arm description

Placebo intramuscular injection single treatment cycle on day 1

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Placebo intramuscular injection single treatment cycle on day 1

Dysport 500 U

Arm description

Botulinum type A toxin (Dysport) 500 U intramuscular injection single treatment cycle on day 1

Arm type

Active comparator

Investigational medicinal product name

Dysport 500 U

Investigational medicinal product code

Other name

Botulinum type A toxin

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Botulinum type A toxin (Dysport) 500 U intramuscular injection single treatment cycle on day 1

Dysport 1000 U

Arm description

Botulinum type A toxin (Dysport) 1000 U intramuscular injection single treatment cycle on day 1

Arm type

Active comparator

Investigational medicinal product name

Dysport 1000 U

Investigational medicinal product code

Other name

Botulinum type A toxin

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Botulinum type A toxin (Dysport) 1000 U intramuscular injection single treatment cycle on day 1

Number of subjects in period 1	Placebo	Dysport 500 U	Dysport 1000 U
Started	81	81	81
Completed	74	78	77
Not completed	7	3	4
lack of subject compliance	-	-	1
Protocol violation	2	-	-
Family reason and moved out of state	-	2	-
Adverse event	3	1	1
Withdrawal by Subject	1	-	2
Lost to follow-up	1	-	-

Baseline characteristics

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Reporting group title

Placebo

Reporting group description

Placebo intramuscular injection single treatment cycle on day 1

Reporting group title

Dysport 500 U

Reporting group description

Botulinum type A toxin (Dysport) 500 U intramuscular injection single treatment cycle on day 1

Reporting group title

Dysport 1000 U

Reporting group description

Botulinum type A toxin (Dysport) 1000 U intramuscular injection single treatment cycle on day 1

Reporting group values	Placebo	Dysport 500 U	Dysport 1000 U	Total
Number of subjects	81	81	81	243
Age categorical
Units: Subjects
<65 years	66	66	61	193
>=65 years	15	15	20	50
Age continuous
Units: years
arithmetic mean (standard deviation)	52.9 ( 13.8 )	52.8 ( 12.8 )	53.2 ( 13.8 )	-
Gender categorical
Units: Subjects
Female	31	28	28	87
Male	50	53	53	156
Race/Ethnicity, Customized
Units: Subjects
Asian	1	3	2	6
Black/African American	9	7	11	27
Caucasian/White	71	70	67	208
Multiple	0	1	1	2
Ethnicity
Units: Subjects
Hispanic/Latino	5	3	10	18
Not Hispanic/Latino	76	78	71	225
BMI
Aggregate analysis for BMI is 27.33(5.17) for participants Placebo: N=78, Dysport 500 U: N=80, and Dysport 1000 U: N=80.
Units: kg/m2
arithmetic mean (standard deviation)	26.78 ( 5.38 )	27.63 ( 4.61 )	27.58 ( 5.51 )	-
Modified Ashworth Scale Score
Aggregate analysis for MAS at baseline is 3.9(0.4) for participants Placebo:N=79, Dysport500U:N=80 & Dysport1000U:N=79. MAS scale is used to assess MT using a 6-point scale where:0=No increase in MT, 1=Slight increase in MT,1±=Slight increase in MT manifested by a catch followed by minimal resistance throughout remainder of ROM,2=Marked increase in MT through most of ROM but affected part easily moved,3=Considerable increase in MT passive movement difficult or 4=Affected part(s) rigid in flexion or extension. The MAS has been derived for analyses as follows:0=0 ; 1=1; 1+=2; 2=3; 3=4; 4=5.
Units: units on a scale
arithmetic mean (standard deviation)	3.9 ( 0.4 )	3.9 ( 0.5 )	3.9 ( 0.4 )	-
Disability Assessment Scale Score
Aggregate analysis for DAS at baseline is 2.6(0.5) for participants Placebo:N=79 Dysport500U:N=80 Dysport1000U:N=78 DAS is a 4-point scale used to determine the extent of functional impairment in 4 functional domains(dressing, hygiene, limb position and pain). DAS scale rating: 0=No disability,1=Mild disability (noticeable but does not interfere significantly with normal activities),2=Moderate disability (normal activities require increased effort and/or assistance),3=Severe disability (normal activities limited). If the subject chose Hygiene as PTT the score collected will be between 0 & 3
Units: units on a scale
arithmetic mean (standard deviation)	2.6 ( 0.5 )	2.6 ( 0.5 )	2.5 ( 0.5 )	-

End points

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Reporting group title

Placebo

Reporting group description

Placebo intramuscular injection single treatment cycle on day 1

Reporting group title

Dysport 500 U

Reporting group description

Botulinum type A toxin (Dysport) 500 U intramuscular injection single treatment cycle on day 1

Reporting group title

Dysport 1000 U

Reporting group description

Botulinum type A toxin (Dysport) 1000 U intramuscular injection single treatment cycle on day 1

Primary: Change From Baseline in MAS Score in the Primary Targeted Muscle Group (PTMG)

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End point title

Change From Baseline in MAS Score in the Primary Targeted Muscle Group (PTMG) ^[1]

End point description

MAS scale is used to assess muscle tone (MT) using a 6-point scale where: 0=No increase in muscle tone, 1=Slight increase in muscle tone manifested by a catch and release or by minimal resistance at the end of the range of motion (ROM) when the part is flexed or extended, 1±Slight increase in muscle tone manifested by a catch followed by minimal resistance throughout the remainder of the ROM, 2=Marked increase in muscle tone through most of the ROM but affected part easily moved, 3=Considerable increase in muscle tone passive movement difficult or 4=Affected part(s) rigid in flexion or extension. The MAS has been derived for analyses as follows: 0=0 ; 1=1; 1+=2; 2=3; 3=4 and 4=5. Intention to treat (ITT) population included all randomized subjects who received at least one injection of study drug and had a MAS score at baseline (pretreatment) and at week 4. Total 5 subjects were excluded from ITT population as they did not have MAS score at baseline or/and at week 4.

End point type

Primary

End point timeframe

From Baseline (Day 1) to Week 4.

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analyses for this endpoint.

End point values	Placebo	Dysport 500 U	Dysport 1000 U
Number of subjects analysed	79	80	79
Units: units on a scale
arithmetic mean (standard deviation)
Change From Baseline in MAS Score in the PTMG	-0.3 ( 0.6 )	-1.2 ( 1 )	-1.4 ( 1.1 )

No statistical analyses for this end point

Secondary: Physician's Global Assessment (PGA) of Treatment Response

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End point title

Physician's Global Assessment (PGA) of Treatment Response

End point description

PGA is a 9-point scale used to assess global overall treatment response by the investigator (-4: markedly worse, -3: much worse, -2: worse, -1: slightly worse, 0: no change, +1: slightly improved, +2: improved, +3: much improved and +4: markedly improved). ITT population. Two subjects each from Placebo and Dysport 1000 U had missed PGA assessment at week 4

End point type

Secondary

End point timeframe

At week 4

End point values	Placebo	Dysport 500 U	Dysport 1000 U
Number of subjects analysed	78	80	78
Units: units on a scale
arithmetic mean (standard deviation)
PGA of Treatment Response	0.6 ( 1 )	1.4 ( 1.1 )	1.8 ( 1.1 )

No statistical analyses for this end point

Secondary: Change From Baseline in DAS Score for the Principal Target of Treatment (PTT)

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End point title

Change From Baseline in DAS Score for the Principal Target of Treatment (PTT)

End point description

DAS is a 4-point scale used to determine the extent of functional impairment in 4 functional domains (dressing, hygiene, limb position and pain). DAS scale rating: 0=No disability, 1=Mild disability (noticeable but does not interfere significantly with normal activities), 2=Moderate disability (normal activities require increased effort and/or assistance) and 3=Severe disability (normal activities limited). If subject chose 'Hygiene' as PTT the score collected will be between 0 and 3. ITT population. Two subjects from Placebo and one subject from Dysport 1000 U had missed DAS assessment at baseline and week 4.

End point type

Secondary

End point timeframe

From Baseline (Day 1) to Week 4

End point values	Placebo	Dysport 500 U	Dysport 1000 U
Number of subjects analysed	79	80	78
Units: units on a scale
arithmetic mean (standard deviation)	-0.5 ( 0.7 )	-0.7 ( 0.8 )	-0.7 ( 0.7 )

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Up to 24±2 weeks

Adverse event reporting additional description

Non-serious adverse event affecting >2% of total subjects are reported.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

16.0

Reporting group title

Placebo

Reporting group description

Placebo intramuscular injection single treatment cycle on day 1

Reporting group title

Dysport 500 U

Reporting group description

Botulinum type A toxin (Dysport) 500 U intramuscular injection single treatment cycle on day 1

Reporting group title

Dysport 1000 U

Reporting group description

Botulinum type A toxin (Dysport) 1000 U intramuscular injection single treatment cycle on day 1

Serious adverse events	Placebo	Dysport 500 U	Dysport 1000 U
Total subjects affected by serious adverse events
subjects affected / exposed	3 / 81 (3.70%)	3 / 81 (3.70%)	3 / 81 (3.70%)
number of deaths (all causes)	1	1	0
number of deaths resulting from adverse events	1	1	0
Injury, poisoning and procedural complications
Craniocerebral injury
subjects affected / exposed	1 / 81 (1.23%)	0 / 81 (0.00%)	0 / 81 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Ligament sprain
subjects affected / exposed	0 / 81 (0.00%)	0 / 81 (0.00%)	1 / 81 (1.23%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Vascular disorders
Behcet's syndrome
subjects affected / exposed	0 / 81 (0.00%)	1 / 81 (1.23%)	0 / 81 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Deep vein thrombosis
subjects affected / exposed	1 / 81 (1.23%)	0 / 81 (0.00%)	0 / 81 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cardiac disorders
Cardiovascular disorder
subjects affected / exposed	0 / 81 (0.00%)	1 / 81 (1.23%)	0 / 81 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	1 / 1	0 / 0
Nervous system disorders
Cerebrovascular accident
subjects affected / exposed	0 / 81 (0.00%)	0 / 81 (0.00%)	1 / 81 (1.23%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Partial seizures
subjects affected / exposed	0 / 81 (0.00%)	0 / 81 (0.00%)	1 / 81 (1.23%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Syncope
subjects affected / exposed	0 / 81 (0.00%)	0 / 81 (0.00%)	1 / 81 (1.23%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
General disorders and administration site conditions
Death
subjects affected / exposed	1 / 81 (1.23%)	0 / 81 (0.00%)	0 / 81 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	1 / 1	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
subjects affected / exposed	1 / 81 (1.23%)	0 / 81 (0.00%)	0 / 81 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Muscle spasms
subjects affected / exposed	0 / 81 (0.00%)	1 / 81 (1.23%)	0 / 81 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Muscular weakness
subjects affected / exposed	1 / 81 (1.23%)	0 / 81 (0.00%)	0 / 81 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Infections and infestations
Sepsis
subjects affected / exposed	0 / 81 (0.00%)	1 / 81 (1.23%)	0 / 81 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 2%

Non-serious adverse events	Placebo	Dysport 500 U	Dysport 1000 U
Total subjects affected by non serious adverse events
subjects affected / exposed	10 / 81 (12.35%)	25 / 81 (30.86%)	18 / 81 (22.22%)
Investigations
Blood glucose increased
subjects affected / exposed	0 / 81 (0.00%)	2 / 81 (2.47%)	0 / 81 (0.00%)
occurrences all number	0	2	0
Blood pressure increased
subjects affected / exposed	0 / 81 (0.00%)	1 / 81 (1.23%)	2 / 81 (2.47%)
occurrences all number	0	1	2
Blood triglycerides increased
subjects affected / exposed	0 / 81 (0.00%)	3 / 81 (3.70%)	1 / 81 (1.23%)
occurrences all number	0	3	1
Gamma glutamyl transferase increased
subjects affected / exposed	0 / 81 (0.00%)	2 / 81 (2.47%)	2 / 81 (2.47%)
occurrences all number	0	2	2
Injury, poisoning and procedural complications
Fall
subjects affected / exposed	0 / 81 (0.00%)	1 / 81 (1.23%)	2 / 81 (2.47%)
occurrences all number	0	1	2
Nervous system disorders
Headache
subjects affected / exposed	0 / 81 (0.00%)	1 / 81 (1.23%)	2 / 81 (2.47%)
occurrences all number	0	1	2
General disorders and administration site conditions
Asthenia
subjects affected / exposed	1 / 81 (1.23%)	2 / 81 (2.47%)	0 / 81 (0.00%)
occurrences all number	1	2	0
Injection site bruising
subjects affected / exposed	2 / 81 (2.47%)	1 / 81 (1.23%)	1 / 81 (1.23%)
occurrences all number	2	1	1
Injection site erythema
subjects affected / exposed	0 / 81 (0.00%)	0 / 81 (0.00%)	2 / 81 (2.47%)
occurrences all number	0	0	2
Injection site pain
subjects affected / exposed	3 / 81 (3.70%)	1 / 81 (1.23%)	0 / 81 (0.00%)
occurrences all number	3	1	0
Gastrointestinal disorders
Diarrhoea
subjects affected / exposed	0 / 81 (0.00%)	2 / 81 (2.47%)	1 / 81 (1.23%)
occurrences all number	0	2	1
Nausea
subjects affected / exposed	0 / 81 (0.00%)	3 / 81 (3.70%)	0 / 81 (0.00%)
occurrences all number	0	3	0
Respiratory, thoracic and mediastinal disorders
Cough
subjects affected / exposed	0 / 81 (0.00%)	2 / 81 (2.47%)	1 / 81 (1.23%)
occurrences all number	0	3	1
Epistaxis
subjects affected / exposed	0 / 81 (0.00%)	2 / 81 (2.47%)	0 / 81 (0.00%)
occurrences all number	0	3	0
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	1 / 81 (1.23%)	2 / 81 (2.47%)	1 / 81 (1.23%)
occurrences all number	1	4	1
Back pain
subjects affected / exposed	1 / 81 (1.23%)	0 / 81 (0.00%)	2 / 81 (2.47%)
occurrences all number	1	0	2
Muscular Weakness
subjects affected / exposed	1 / 81 (1.23%)	2 / 81 (2.47%)	4 / 81 (4.94%)
occurrences all number	1	2	4
Musculoskeletal pain
subjects affected / exposed	1 / 81 (1.23%)	2 / 81 (2.47%)	1 / 81 (1.23%)
occurrences all number	1	2	1
Infections and infestations
Nasopharyngitis
subjects affected / exposed	1 / 81 (1.23%)	7 / 81 (8.64%)	1 / 81 (1.23%)
occurrences all number	1	7	1
Sinusitis
subjects affected / exposed	0 / 81 (0.00%)	2 / 81 (2.47%)	1 / 81 (1.23%)
occurrences all number	0	2	1
Urinary tract infections
subjects affected / exposed	0 / 81 (0.00%)	2 / 81 (2.47%)	1 / 81 (1.23%)
occurrences all number	0	2	1

More information

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Were there any global substantial amendments to the protocol? Yes

14 Apr 2011

Protocol amendment 1: Made the following changes: • The primary efficacy analysis was changed from a Hochberg procedure to a hierarchical testing procedure following feedback from the Food and Drug Administration. • The procedure for breaking the blind was clarified. • The definition of treatment naïve was harmonised to that used in similar protocols. • Minor formatting and typographical issues were corrected.

17 Feb 2012

Protocol amendment 2: Made the following changes: •In inclusion criterion 2, it was clarified that subjects had to have a diagnosis of hemiparesis. • In inclusion criterion 5, the definition of naïve/non-naïve subjects was clarified. Naive subjects were defined as those who had never previously received BTX in the injected upper limb. • In exclusion criterion 6, the text for exclusion due to surgery was clarified and made more specific. • Exclusion criterion 20 was added to exclude the use of intrathecal baclofen during or for the 4 weeks prior to the study. • For the PTMG for elbow flexors, a clarification was added regarding the choice of ‘brachialis’ or ‘brachialis and brachioradialis’. • For the assessments of upper limb muscle groups, assessments for elbow pronators were removed owing to the number of evaluations to be performed. • Minor formatting and typographical issues were corrected. • The time for which subjects were required to be supine before ECG was recorded was corrected. • Text was added to item 9 in the Modified Frenchay Scale to clarify that the affected hand holds the fork during the assessment. In light of the amendment, the CRF, database and RAP required updating.

12 Jul 2012

Protocol amendment 3, dated 12 July 2012, made the following changes: • The pharmacovigilance/emergency contact details for the USA were updated. • Inclusion criterion 3 was altered to allow entry into the study of subjects with a non-evolutive lesion diagnosed before the stroke and in the same cerebral hemisphere. • Inclusion criterion 7 was altered to include subjects with a spasticity angle of 10°. • The wording of Section 9.5 was amended to clarify the meaning and take into account all possibilities regarding used and unused treatments and empty boxes for destruction. • References to Sponsor’s CDDS Department were amended to Statistics Department. • Instructions for disposal of used vials were clarified.

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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