Clinical Trial Results:
A 12-weeks, multicentre, randomized, double-blind, placebo-controlled, exploratory, pilot study to evaluate the safety and efficacy of safinamide 200 mg once daily, as add-on therapy, in patients with possible or probable parkinsonian variant of multiple system atrophy.
Summary
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EudraCT number |
2018-004145-16 |
Trial protocol |
ES IT |
Global end of trial date |
05 Jan 2021
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Results information
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Results version number |
v1(current) |
This version publication date |
29 Jul 2021
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First version publication date |
29 Jul 2021
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
Z7219K01
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT03753763 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Zambon S.p.A.
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Sponsor organisation address |
Via Lillo del Duca 10, Bresso (MI), Italy, 20091
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Public contact |
Clinical Development Manager, Zambon S.p.A., +39 02665241, clinicaltrials@zambongroup.com
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Scientific contact |
Clinical Development Manager, Zambon S.p.A., +39 02665241, clinicaltrials@zambongroup.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
05 Jan 2021
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
05 Jan 2021
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Global end of trial reached? |
Yes
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Global end of trial date |
05 Jan 2021
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
Safety: To evaluate the safety and tolerability of safinamide 200 mg once daily compared with placebo.
Efficacy: To evaluate the potential efficacy of safinamide 200 mg once daily, as add-on therapy, on motor function and/or quality of life.
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Protection of trial subjects |
The study was conducted in accordance with the Declaration of Helsinki and its subsequent revisions, Regulation (European Union) No 536/2014, Commission Directive 2005/28/EC, and with all applicable laws and regulations of the locale and country where the study was conducted, and in compliance with International Council for Harmonisation (ICH) E6 Good Clinical Practice Guidelines.
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Background therapy |
Oral daily Levodopa alone or in combination with other anti-parkinsonian drugs (such as dopamine agonist, anticholinergic, and/or amantadine) allowed for MSA treatment. | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
29 Oct 2019
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Italy: 36
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Country: Number of subjects enrolled |
Spain: 13
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Worldwide total number of subjects |
49
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EEA total number of subjects |
49
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
28
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From 65 to 84 years |
21
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85 years and over |
0
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Recruitment
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Recruitment details |
Approximately 56 participants were planned to be screened in order to achieve 49 participants randomly assigned (2:1) to study drug and 42 evaluable participants, resulting in a planned estimated total of 32 evaluable participants receiving safinamide and 17 evaluable participants receiving matching placebo. | |||||||||||||||||||||
Pre-assignment
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Screening details |
After providing written informed consent to participate in the study, participants entered a Screening period of up to 2 weeks. During the Screening period, participants underwent all of the evaluations necessary to establish their eligibility for the study and were assigned a unique screening number. | |||||||||||||||||||||
Period 1
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Period 1 title |
Overall study (overall period)
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Is this the baseline period? |
Yes | |||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||||||||||||||
Roles blinded |
Subject, Investigator | |||||||||||||||||||||
Blinding implementation details |
This was a double-blind study; therefore, the Sponsor, Investigator, and participant did not know the study drugs being administered.
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Safinamide | |||||||||||||||||||||
Arm description |
Safinamide methanesulfonate film-coated tablets once daily. During the titration period of 2 weeks (Week 1 to Week 2) participants received 1 tablet (100 mg) safinamide, while during the treatment period (Week 3 to Week 12) they received 2 tablets (200 mg) safinamide once-a-day, taken in the morning, in addition to their daily levodopa dose. | |||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||
Investigational medicinal product name |
Safinamide
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Investigational medicinal product code |
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Other name |
safinamide methanesulfonate
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Pharmaceutical forms |
Film-coated tablet
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Routes of administration |
Oral use
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Dosage and administration details |
During the titration period of 2 weeks (Week 1 to Week 2) participants received 1 tablet (100 mg) safinamide once-daily.
During the treatment period (Week 3 to Week 12) they received 2 tablets (200 mg) safinamide once-a-day.
Tablets were taken in the morning, along with patients' first levodopa dose of the day.
Safinamide was supplied as 100 mg round, orange to copper, biconcave, film-coated tablets.
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Arm title
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Placebo | |||||||||||||||||||||
Arm description |
Safinamide methanesulfonate matching placebo film-coated tablets once daily. Safinamide matching placebo was administered both during the titration period of 2 weeks (Week 1 to Week 2) and during the following period (Week 3 to Week 12), once daily, taken in the morning, in addition to their daily levodopa dose. | |||||||||||||||||||||
Arm type |
Placebo | |||||||||||||||||||||
Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Film-coated tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Placebo was administered both during the titration period of 2 weeks (Week 1 to Week 2) and during the following period (Week 3 to Week 12), once daily, taken in the morning, in addition to their daily levodopa dose.
Safinamide matching placebo was supplied as 100 mg round, orange to copper, biconcave, film-coated tablets.
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Baseline characteristics reporting groups
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Reporting group title |
Safinamide
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Reporting group description |
Safinamide methanesulfonate film-coated tablets once daily. During the titration period of 2 weeks (Week 1 to Week 2) participants received 1 tablet (100 mg) safinamide, while during the treatment period (Week 3 to Week 12) they received 2 tablets (200 mg) safinamide once-a-day, taken in the morning, in addition to their daily levodopa dose. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo
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Reporting group description |
Safinamide methanesulfonate matching placebo film-coated tablets once daily. Safinamide matching placebo was administered both during the titration period of 2 weeks (Week 1 to Week 2) and during the following period (Week 3 to Week 12), once daily, taken in the morning, in addition to their daily levodopa dose. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
Safinamide - ITT
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Subject analysis set type |
Intention-to-treat | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
The ITT Population included all randomized participants. This population was used for describing all the demographic characteristics and all efficacy variables.
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Subject analysis set title |
Safinamide - PP
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Subject analysis set type |
Per protocol | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
The Per Protocol Population will include all randomized participants who do not have any entry criteria violations or protocol deviations that could significantly impact the assessment or interpretation of efficacy data.
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Subject analysis set title |
Safinamide - Safety
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Subject analysis set type |
Safety analysis | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
The Safety Population included all randomized participants who took at least 1 dose of study drug. This population was used to summarize all safety data; participants were analyzed according to the drug they actually received.
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Subject analysis set title |
Placebo - ITT
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Subject analysis set type |
Intention-to-treat | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
The ITT Population included all randomized participants. This population was used for all efficacy variables.
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Subject analysis set title |
Placebo - PP
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Subject analysis set type |
Per protocol | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
The Per-Protocol (PP) Population included all randomized participants who did not have any entry criteria violations or protocol deviations that significantly impacted the assessment or interpretation of efficacy data.
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Subject analysis set title |
Placebo - Safety
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Subject analysis set type |
Safety analysis | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
The Safety Population included all randomized participants who took at least 1 dose of study drug. This population was used to summarize all safety data; participants were analyzed according to the drug they actually received.
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End points reporting groups
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Reporting group title |
Safinamide
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Reporting group description |
Safinamide methanesulfonate film-coated tablets once daily. During the titration period of 2 weeks (Week 1 to Week 2) participants received 1 tablet (100 mg) safinamide, while during the treatment period (Week 3 to Week 12) they received 2 tablets (200 mg) safinamide once-a-day, taken in the morning, in addition to their daily levodopa dose. | ||
Reporting group title |
Placebo
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Reporting group description |
Safinamide methanesulfonate matching placebo film-coated tablets once daily. Safinamide matching placebo was administered both during the titration period of 2 weeks (Week 1 to Week 2) and during the following period (Week 3 to Week 12), once daily, taken in the morning, in addition to their daily levodopa dose. | ||
Subject analysis set title |
Safinamide - ITT
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Subject analysis set type |
Intention-to-treat | ||
Subject analysis set description |
The ITT Population included all randomized participants. This population was used for describing all the demographic characteristics and all efficacy variables.
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Subject analysis set title |
Safinamide - PP
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
The Per Protocol Population will include all randomized participants who do not have any entry criteria violations or protocol deviations that could significantly impact the assessment or interpretation of efficacy data.
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Subject analysis set title |
Safinamide - Safety
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Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
The Safety Population included all randomized participants who took at least 1 dose of study drug. This population was used to summarize all safety data; participants were analyzed according to the drug they actually received.
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Subject analysis set title |
Placebo - ITT
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Subject analysis set type |
Intention-to-treat | ||
Subject analysis set description |
The ITT Population included all randomized participants. This population was used for all efficacy variables.
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Subject analysis set title |
Placebo - PP
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
The Per-Protocol (PP) Population included all randomized participants who did not have any entry criteria violations or protocol deviations that significantly impacted the assessment or interpretation of efficacy data.
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Subject analysis set title |
Placebo - Safety
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Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
The Safety Population included all randomized participants who took at least 1 dose of study drug. This population was used to summarize all safety data; participants were analyzed according to the drug they actually received.
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End point title |
TEAEs (treatment emergent adverse events) and SAEs (serious adverse events) [1] | |||||||||||||||||||||||||||||||||
End point description |
While evaluating safety and tolerability of safinamide, 200 mg od, compared with placebo, severity of TEAEs, their relationship to study drug, their seriousness and their consequences were assessed. TEAEs were defined as adverse events (AEs) that started after the first dose of study drug.
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End point type |
Primary
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End point timeframe |
Throughout the study, from baseline (and at each interim visit) to telephone follow-up visit at 14 week.
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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: Measure type "Number" related to adverse events can't have a statistical analysis |
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No statistical analyses for this end point |
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End point title |
Change from baseline to week 12 in the goniometric measurement for anterior displacement | ||||||||||||
End point description |
To evaluate the potential efficacy of safinamide 200 mg od, as add-on therapy, on quality of life (change in anterior displacement). The goniometric measurement consists in the posture evaluation of the patient, measuring through a goniometer the angle of the flexion of the trunk. Goniometric measurement of “anterior” displacement was determined using a wall goniometer and expressing the value in degrees in the range of 0 to 90.
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End point type |
Secondary
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End point timeframe |
From baseline to week 12
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Statistical analysis title |
Safinamide vs placebo | ||||||||||||
Comparison groups |
Safinamide - ITT v Placebo - ITT
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Number of subjects included in analysis |
49
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Analysis specification |
Pre-specified
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Analysis type |
superiority [2] | ||||||||||||
P-value |
= 0.9697 [3] | ||||||||||||
Method |
Mixed models analysis | ||||||||||||
Parameter type |
least square mean difference | ||||||||||||
Point estimate |
0.1
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-6.3 | ||||||||||||
upper limit |
6.5 | ||||||||||||
Notes [2] - The model included treatment, week of visit, and treatment-by-visit interaction as fixed effects and baseline score as a covariate. [3] - A mixed-model repeated measures (MMRM) was used to analyze the change in anterior displacement from baseline. |
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End point title |
Change From Baseline to Week 12 in the Goniometric Measurement for lateral Displacement | ||||||||||||
End point description |
To evaluate the potential efficacy of safinamide 200 mg od, as add-on therapy, on quality of life (change in anterior displacement). The goniometric measurement consists in the posture evaluation of the patient, measuring through a goniometer the angle of the flexion of the trunk. Goniometric measurement of “lateral” displacement was determined using a wall goniometer and expressing the value in degrees in the range of 0 to 90.
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End point type |
Secondary
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End point timeframe |
From baseline to week 12
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Statistical analysis title |
Safinamide vs placebo | ||||||||||||
Comparison groups |
Safinamide - ITT v Placebo - ITT
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Number of subjects included in analysis |
49
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Analysis specification |
Pre-specified
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Analysis type |
superiority [4] | ||||||||||||
P-value |
= 0.7751 [5] | ||||||||||||
Method |
Mixed models analysis | ||||||||||||
Parameter type |
least square mean difference | ||||||||||||
Point estimate |
0.5
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-3.1 | ||||||||||||
upper limit |
4.1 | ||||||||||||
Notes [4] - The model included treatment, week of visit, and treatment-by-visit interaction as fixed effects and baseline score as a covariate. [5] - A mixed-model repeated measures (MMRM) was used to analyze the change in lateral displacement from baseline. |
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End point title |
Change From Baseline to Week 12 in Unified Multiple System Atrophy Rating Scale (UMSARS), Part II (ITT Population) | ||||||||||||
End point description |
UMSARS is a validated, disease-specific scale representing the diverse signs and symptoms in MSA. Higher scores on the UMSARS scales mean poorer health.
UMSARS has the following domains:
Part I - Activities of Daily Living score (12 questions ranged in 0-4 [total score 0-48]) that evaluates motor including autonomic activities
Part II - Motor Examination score (14 questions, [total score 0-56])
Part III - Autonomic Examination
Part IV - Global disability scale ((1=completely independent; 2=not completely independent; 3=more dependent; 4=very dependent; 5=total
dependent and helpless).
Only UMSARS Part II total score is reported, which was obtained as the sum of the 14 items in the scale. If any of the items were missing, then the total score was considered missing. Higher scores indicate worse functional situation.
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End point type |
Secondary
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End point timeframe |
From baseline to week 12
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Statistical analysis title |
Safinamide vs placebo | ||||||||||||
Comparison groups |
Safinamide - ITT v Placebo - ITT
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Number of subjects included in analysis |
49
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Analysis specification |
Pre-specified
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Analysis type |
superiority [6] | ||||||||||||
P-value |
= 0.9076 [7] | ||||||||||||
Method |
Mixed models analysis | ||||||||||||
Parameter type |
least square mean difference | ||||||||||||
Point estimate |
0.2
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-3.3 | ||||||||||||
upper limit |
3.7 | ||||||||||||
Notes [6] - The model included treatment, week of visit, and treatment-by-visit interaction as fixed effects and baseline score as a covariate. [7] - The MMRM analysis, specified in Section Goniometric measurement, was used to analyze the change in Part II total scores from baseline. |
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End point title |
Change From Baseline to Week 12 in Unified Multiple System Atrophy Rating Scale (UMSARS), Part II (PP Population) | ||||||||||||
End point description |
UMSARS is a validated, disease-specific scale representing the diverse signs and symptoms in MSA. Higher scores on the UMSARS scales mean poorer health.
UMSARS has the following domains:
Part I - Activities of Daily Living score (12 questions ranged in 0-4 [total score 0-48]) that evaluates motor including autonomic activities
Part II - Motor Examination score (14 questions, [total score 0-56])
Part III - Autonomic Examination
Part IV - Global disability scale ((1=completely independent; 2=not completely independent; 3=more dependent; 4=very dependent; 5=total
dependent and helpless).
Only UMSARS Part II total score is reported, which was obtained as the sum of the 14 items in the scale. If any of the items were missing, then the total score was considered missing. Higher scores indicate worse functional situation.
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End point type |
Secondary
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End point timeframe |
From baseline to week 12
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Statistical analysis title |
Safinamide vs placebo | ||||||||||||
Comparison groups |
Placebo - PP v Safinamide - PP
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Number of subjects included in analysis |
34
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Analysis specification |
Pre-specified
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Analysis type |
superiority [8] | ||||||||||||
P-value |
= 0.5386 [9] | ||||||||||||
Method |
Mixed models analysis | ||||||||||||
Parameter type |
least square mean difference | ||||||||||||
Point estimate |
-1.1
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-4.8 | ||||||||||||
upper limit |
2.6 | ||||||||||||
Notes [8] - The model included treatment, week of visit, and treatment-by-visit interaction as fixed effects and baseline score as a covariate. [9] - A mixed-model repeated measures (MMRM) was used to analyze the change in from baseline in UMSARS Part II. |
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End point title |
Change From Baseline to Week 12 in Multiple System Atrophy Health-Related Quality of Life (MSA-QoL) Scale | ||||||||||||
End point description |
The MSA-QoL is a self-reported questionnaire focusing on MSA-specific symptoms and has a scale ranging from 0 to 160, with 0= 'no problem' and 160= "extreme problem".
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End point type |
Secondary
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End point timeframe |
From baseline to week 12
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
Safinamide vs placebo | ||||||||||||
Comparison groups |
Safinamide - ITT v Placebo - ITT
|
||||||||||||
Number of subjects included in analysis |
49
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority [10] | ||||||||||||
P-value |
= 0.3364 [11] | ||||||||||||
Method |
Mixed models analysis | ||||||||||||
Parameter type |
least square mean difference | ||||||||||||
Point estimate |
6
|
||||||||||||
Confidence interval |
|||||||||||||
level |
95% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
-6.5 | ||||||||||||
upper limit |
18.6 | ||||||||||||
Notes [10] - The model included treatment, week of visit, and treatment-by-visit interaction as fixed effects and baseline score as a covariate. [11] - A mixed-model repeated measures (MMRM) was used to analyze the change in from baseline in MSA-QoL scale. |
|
|||||||||||||
End point title |
Change From Baseline to Week 12 in Montreal Cognitive Assessment (MoCA) Scale | ||||||||||||
End point description |
The Montreal Cognitive Assessment (MoCA) was designed as a tool for rapid screening for mild cognitive impairment. It evaluates different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructive skills, abstraction, calculation and orientation. The administration time of the MoCa is 10 minutes. The MoCA scale ranges from 0 to 30, with higher scores indicating better cognitive functioning.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
From baseline to week 12
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
Safinamide vs placebo | ||||||||||||
Comparison groups |
Safinamide - ITT v Placebo - ITT
|
||||||||||||
Number of subjects included in analysis |
49
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority [12] | ||||||||||||
P-value |
= 0.7574 | ||||||||||||
Method |
ANCOVA | ||||||||||||
Parameter type |
least square mean difference | ||||||||||||
Point estimate |
0.2
|
||||||||||||
Confidence interval |
|||||||||||||
level |
95% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
-1.1 | ||||||||||||
upper limit |
1.5 | ||||||||||||
Notes [12] - Change from Screening at Week 12 was analyzed by an analysis of covariance (ANCOVA). The ANCOVA included change from baseline as the response variable, treatment group as a factor, and baseline score as a covariate. |
|
|||||||||||||
End point title |
Change From Baseline to Week 12 in Unified Dystonia Rating Scale (UDRS) | ||||||||||||
End point description |
UDRS consists of a Historical Section, divided into questionnaires about 1) on-dyskinesia and 2) off -dystonia, and an Objective Section, divided into 3) impairment and 4) disability scales. The Historical Section is scored from 0-60, and the Objective section is scored 0-44, where higher scores reflect greater difficulty or impairment.
The Unified Dystonia Rating Scale (UDRS) assesses the motor severity and duration of dystonia in 14 body areas. The total score, obtained as the sum of the severity and duration factors, ranges from 0 to 112. Higher scores indicate worse dystonia.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
From baseline to week 12
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
Safinamide vs placebo | ||||||||||||
Comparison groups |
Safinamide - ITT v Placebo - ITT
|
||||||||||||
Number of subjects included in analysis |
49
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority [13] | ||||||||||||
P-value |
= 0.6393 [14] | ||||||||||||
Method |
Mixed models analysis | ||||||||||||
Parameter type |
least square mean difference | ||||||||||||
Point estimate |
0.8
|
||||||||||||
Confidence interval |
|||||||||||||
level |
95% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
-2.5 | ||||||||||||
upper limit |
4 | ||||||||||||
Notes [13] - The model included treatment, week of visit, and treatment-by-visit interaction as fixed effects and baseline score as a covariate. [14] - A mixed-model repeated measures (MMRM) was used to analyze the change from baseline in UDRS. |
|
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Adverse events information
|
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Timeframe for reporting adverse events |
At baseline, at interim visits (Weeks 2 - 8, and more precisely at days 14 ± 3, 28 ± 3, 56 ± 3), at End of Treatment visit (EOT) at Week 12 (84 ± 3 days), and at follow-up call at week 14 ( 98 ± 3).
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
23.0
|
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Reporting groups
|
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Reporting group title |
Safinamide - safety
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Safinamide methanesulfonate film-coated tablets once daily. During the titration period of 2 weeks (Week 1 to Week 2) participants received 1 tablet (100 mg) safinamide, while during the treatment period (Week 3 to Week 12) they received 2 tablets (200 mg) safinamide once-a-day, taken in the morning, in addition to their daily levodopa dose. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo - safety
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Safinamide methanesulfonate matching placebo film-coated tablets once daily. Safinamide matching placebo was administered both during the titration period of 2 weeks (Week 1 to Week 2) and during the following period (Week 3 to Week 12), once daily, taken in the morning, in addition to their daily levodopa dose. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
|||
Substantial protocol amendments (globally) |
|||
Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
||
13 Jul 2020 |
This amendment was developed to formally incorporate the administrative letter, to add details of measures taken during the COVID-19 pandemic, to clarify and correct inconsistencies in the original Protocol raised from the Italian Health Authority and/or Italian Coordinating Site, to address an inconsistency within the Protocol in regard to the number of evaluable participants, to provide additional clarifications on the sample size determination background, and to provide information on the benefit/risk assessment as outlined in the 09 August 2019 administrative letter. |
||
Interruptions (globally) |
|||
Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
No limitations or caveats were applicable to this summary of the results |