Clinical Trial Results:
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Exploratory Study to Assess the Effect of Treatment With Prolonged-Release Fampridine (BIIB041) 10 mg Twice Daily on Walking Ability and Balance in Subjects with Multiple Sclerosis (MOBILE)
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Summary
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EudraCT number |
2012-000368-90 |
Trial protocol |
BE GB NL IT |
Global end of trial date |
08 Aug 2013
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Results information
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Results version number |
v1(current) |
This version publication date |
04 Feb 2016
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First version publication date |
06 Aug 2015
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Other versions |
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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 |
218MS205
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Biogen
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Sponsor organisation address |
225 Binney Street, Cambridge, United States, 02142
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Public contact |
Biogen Study Medical Director, Biogen, clinicaltrials@biogen.com
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Scientific contact |
Biogen Study Medical Director, Biogen, clinicaltrials@biogen.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 |
08 Aug 2013
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
08 Aug 2013
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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 |
The objectives of this study were as follows:
-to assess the effect of prolonged-release fampridine over 24 weeks on the following parameters to explore endpoints for the Phase 3 study: self-assessed walking disability, dynamic and static balance, subjective impression of well-being, and subjects’ global impression of change in walking
-to evaluate the safety and tolerability of prolonged-release fampridine
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Protection of trial subjects |
Written informed consent was obtained from each subject prior to evaluations being performed for eligibility. Subjects were given adequate time to review the information in the informed consent and were allowed to ask, and have answered, questions concerning all portions of the conduct of the study. Through the informed consent process each subject was made aware of the purpose of the study, the procedures, the benefits and risks of the study, the discomforts and the precautions taken. Any side effects or other health issues occurring during the study were followed up by the study doctor. Subjects were able to stop taking part in the study at any time without giving any reason.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
30 Aug 2012
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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 |
Netherlands: 17
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Country: Number of subjects enrolled |
Sweden: 19
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Country: Number of subjects enrolled |
United Kingdom: 18
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Country: Number of subjects enrolled |
Belgium: 20
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Country: Number of subjects enrolled |
Italy: 31
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Country: Number of subjects enrolled |
Canada: 27
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Worldwide total number of subjects |
132
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EEA total number of subjects |
105
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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) |
126
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From 65 to 84 years |
6
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85 years and over |
0
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Recruitment
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Recruitment details |
Recruitment/enrollment was at a single investigational site in The Netherlands. | ||||||||||||||||||||||||
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Pre-assignment
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Screening details |
This study included a 14-day screening period. | ||||||||||||||||||||||||
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Period 1
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Period 1 title |
Double-blind period + 2-week Follow-up (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, Carer, Assessor | ||||||||||||||||||||||||
Blinding implementation details |
All subjects and study staff, including the Neurologist, were blinded to the subject treatment assignments.
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Placebo | ||||||||||||||||||||||||
Arm description |
Placebo tablet twice daily (BID) | ||||||||||||||||||||||||
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 |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Study treatment was to be dispensed by a pharmacist or appropriately qualified staff, and only to subjects enrolled in this study. Staff were to refer to the Directions for Handling and Administration for specific instructions about handling, preparation, administration, and disposal of study treatment.
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Arm title
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Fampridine 10 mg BID | ||||||||||||||||||||||||
Arm description |
Prolonged-release fampridine 10 mg tablet BID | ||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||
Investigational medicinal product name |
fampridine
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Investigational medicinal product code |
BIIB041
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Other name |
Fampyra, fampridine-PR
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Pharmaceutical forms |
Prolonged-release tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Study treatment was to be dispensed by a pharmacist or appropriately qualified staff, and only to subjects enrolled in this study. Staff were to refer to the Directions for Handling and Administration for specific instructions about handling, preparation, administration, and disposal of study treatment.
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Baseline characteristics reporting groups
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Reporting group title |
Placebo
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Reporting group description |
Placebo tablet twice daily (BID) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Fampridine 10 mg BID
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Reporting group description |
Prolonged-release fampridine 10 mg tablet BID | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Placebo
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Reporting group description |
Placebo tablet twice daily (BID) | ||
Reporting group title |
Fampridine 10 mg BID
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Reporting group description |
Prolonged-release fampridine 10 mg tablet BID | ||
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End point title |
Change From Baseline to Mean On-treatment (Weeks 2 to 24) on the Multiple Sclerosis Walking Scale-12 (MSWS-12) | ||||||||||||
End point description |
The MSWS-12 is a 12-item questionnaire that asks subjects to rate limitations of their mobility due to multiple sclerosis (MS) during the preceding 2 weeks on a 5-point scale (from 1= not at all to 5= extremely). The higher the score, the greater the degree of limitation in walking caused by MS. A negative change indicates an improvement in walking. For each subject, the mean change from baseline to on-treatment was calculated. As the distribution of between-subject changes from baseline were not normally distributed, the median change from baseline and corresponding 95% confidence interval (CI) were calculated for each treatment group. Treatment groups were compared using median differences and corresponding 95% CI, which were calculated using non-parametric methods. Missing data were imputed by last observation carried forward (LOCF) method. Intention to treat (ITT) population: all treated subjects.
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End point type |
Primary
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End point timeframe |
Baseline (mean of Screening and Day 1 visits) up to Week 24 (mean of Weeks 2, 4, 8, 12, 16, 20 and 24 [or early termination] visits)
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Statistical analysis title |
Estimate of median difference | ||||||||||||
Statistical analysis description |
Estimate of median difference: fampridine minus placebo. Median difference and corresponding non-parametric 95% CI determined from all possible differences between the two treatment groups.
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Comparison groups |
Placebo v Fampridine 10 mg BID
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Number of subjects included in analysis |
132
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
Method |
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Parameter type |
Median difference (net) | ||||||||||||
Point estimate |
-3.27
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-7.59 | ||||||||||||
upper limit |
1.19 | ||||||||||||
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End point title |
Percentage Change From Baseline to Mean On-treatment (Weeks 2 to 24) on the Timed Up and Go (TUG) | ||||||||||||
End point description |
TUG was presented using speed in meters per second (m/s), derived by dividing 6 meters by the time (in seconds) required to complete the walk. At each study visit, there were 2 trials of the TUG; the speed for any particular study visit was calculated as the average of the speeds for trial 1 and trial 2. If either trial was missing, then the speed for that visit was the speed from the completed trial. For each subject, the mean change from baseline to on-treatment was calculated. As the distribution of between-subject changes from baseline were not normally distributed, the median change from baseline and corresponding 95% confidence interval were calculated for each treatment group. Treatment groups were compared using median differences and corresponding 95% CI, which were calculated using non-parametric methods. Missing data were imputed by LOCF method. ITT population: all treated subjects.
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End point type |
Primary
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End point timeframe |
Baseline (mean of Screening and Day 1 visits) up to Week 24 (mean of Weeks 2, 4, 8, 12, 16, 20 and 24 [or early termination] visits)
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| Notes [1] - subjects in the ITT population with data available at baseline and on-treatment |
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Statistical analysis title |
Estimate of median difference | ||||||||||||
Statistical analysis description |
Estimate of median difference: fampridine minus placebo. Median difference and corresponding non-parametric 95% CI determined from all possible differences between the two treatment groups.
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Comparison groups |
Placebo v Fampridine 10 mg BID
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Number of subjects included in analysis |
131
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
Method |
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Parameter type |
Median difference (net) | ||||||||||||
Point estimate |
9.64
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
2.05 | ||||||||||||
upper limit |
16.48 | ||||||||||||
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End point title |
Change From Baseline to Mean On-treatment (Weeks 2 to 24) on the Berg Balance Scale (BBS) | ||||||||||||
End point description |
The BBS test comprises 14 balance-related tasks scored from 0 (unable to perform) to 4 (able to perform independently). The BBS is the sum of scores across these tasks and ranges from 0 (poor balance) to 56 (good balance). A positive change on the BBS indicates an improvement in balance. For each subject, the mean change from baseline to on-treatment was calculated. As the distribution of between-subject changes from baseline were not normally distributed, the median change from baseline and corresponding 95% CI were calculated for each treatment group. Treatment groups were compared using median differences and corresponding 95% CI, which were calculated using non-parametric methods. Missing data were imputed by LOCF method. ITT population: all treated subjects.
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End point type |
Primary
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End point timeframe |
Baseline (mean of Screening and Day 1 visits) up to Week 24 (Weeks 2, 4, 8, 12, 16, 20 and 24 [or early termination] visits)
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| Notes [2] - subjects in the ITT population with data available at baseline and on-treatment |
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Statistical analysis title |
Estimate of median difference | ||||||||||||
Statistical analysis description |
Estimate of median difference: fampridine minus placebo. Median difference and corresponding non-parametric 95% CI determined from all possible differences between the two treatment groups.
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Comparison groups |
Placebo v Fampridine 10 mg BID
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Number of subjects included in analysis |
131
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
Method |
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Parameter type |
Median difference (net) | ||||||||||||
Point estimate |
1.5
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
0 | ||||||||||||
upper limit |
2.93 | ||||||||||||
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End point title |
Change From Baseline to Mean On-treatment (Weeks 2 to 24) on the Multiple Sclerosis Impact Scale-29 (MSIS-29) Physical Impact Score | ||||||||||||
End point description |
MSIS-29 is a subject-completed questionnaire comprising 29 questions measuring the physical (questions 1 to 20) and psychological (questions 21 to 29) impact of MS. For a particular visit, the MSIS-29 physical subscale score was calculated by summing the 20 items and transforming to a scale with a range of 0 (no impact of MS) to 100 (extreme impact of MS). A negative change indicates an improvement in function. For each subject, the mean change from baseline to on-treatment was calculated. As the distribution of between-subject changes from baseline were not normally distributed, the median change from baseline and corresponding 95% CI were calculated for each treatment group. Treatment groups were compared using median differences and corresponding 95% CI, which were calculated using non-parametric methods. Missing data were imputed by LOCF method. ITT population: all treated subjects.
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End point type |
Primary
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End point timeframe |
Baseline (mean of Screening and Day 1 visits) up to Week 24 (mean of Weeks 2, 4, 8, 12, 16, 20 and 24 [or early termination] visits)
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Statistical analysis title |
Estimate of median difference | ||||||||||||
Statistical analysis description |
Estimate of median difference: fampridine minus placebo. Median difference and non-parametric CI determined from all possible differences between the two treatment groups.
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Comparison groups |
Placebo v Fampridine 10 mg BID
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Number of subjects included in analysis |
132
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
Method |
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Parameter type |
Median difference (net) | ||||||||||||
Point estimate |
-3.3
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-7.68 | ||||||||||||
upper limit |
0.98 | ||||||||||||
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End point title |
Change from Baseline to Mean On-treatment (Weeks 4 to 24) in EuroQoL Descriptive System of Health-related Quality of Life States Consisting of 5 Dimensions (EQ-5D) Visual Analogue Scale (VAS) | ||||||||||||
End point description |
The EQ-5D is a generic quality of life instrument that comprises 5 questions and a VAS. The VAS ranges from 0 (worst imagined health state) to 100 (best imagined health state). A positive change indicates an improvement in health state. An analysis of covariance (ANCOVA) with adjustment for baseline values was used to calculate least squares means and corresponding 95% CI for each treatment group, as well as the least squares mean differences and corresponding 95% CI. No imputation for missing data was performed. ITT population: all treated subjects.
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End point type |
Primary
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End point timeframe |
Baseline (Day 1), up to Week 24 (mean of Weeks 4, 8, 12, 16, 20 and 24 [or early termination] visits)
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Statistical analysis title |
Least squares mean difference | ||||||||||||
Statistical analysis description |
Least squares mean difference: calculated from an ANCOVA model with adjustment for baseline value.
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Comparison groups |
Placebo v Fampridine 10 mg BID
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Number of subjects included in analysis |
131
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
Method |
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Parameter type |
least squares mean difference | ||||||||||||
Point estimate |
0.55
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-4.07 | ||||||||||||
upper limit |
5.18 | ||||||||||||
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End point title |
Change from Baseline to Mean On-treatment (Weeks 4 to 24) in EQ-5D Utility Score | ||||||||||||
End point description |
The EQ-5D is a generic quality of life instrument that comprises 5 questions and a VAS. Questions address mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. A score of 1 (no problem) to 5 (severe problem) are possible responses. A summary utility index value was calculated for subjects with non-missing data for each of the 5 questions at a visit. EQ-5D utility score ranges from -0.594 (worst health state) to 1.000 (best health state). A positive change indicates an improvement in utility score. An ANCOVA with adjustment for baseline values was used to calculate least squares means and corresponding 95% CI for each treatment group, as well as the least squares mean differences and corresponding 95% CI. No imputation for missing data was performed. ITT population: all treated subjects.
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End point type |
Primary
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End point timeframe |
Baseline (Day 1) up to Week 24 (Mean of Weeks 4, 8, 12, 16, 20, and 24 [or early termination] visits)
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Statistical analysis title |
Least squares mean difference | ||||||||||||
Statistical analysis description |
Least squares mean difference: calculated from an ANCOVA model with adjustment for baseline value.
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Comparison groups |
Placebo v Fampridine 10 mg BID
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Number of subjects included in analysis |
132
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
Method |
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Parameter type |
least squares mean of difference | ||||||||||||
Point estimate |
0.0225
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-0.031 | ||||||||||||
upper limit |
0.076 | ||||||||||||
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End point title |
Percentage of Subjects With an Improvement on the Patient Global Impression of Change (PGIC) at Week 2 [3] | ||||||||||||
End point description |
The PGIC is a global assessment of the subject’s impression of how the study drug affected their overall walking during the preceding 7 days. The assessment is scored on a 7-point scale (1=very much worse, 2=much worse, 3=slightly worse, 4=unchanged, 5=slightly improved, 6=much improved, 7=very much improved). The number and proportion of subjects with an improvement (i.e., a score of 5, 6, or 7) at Week 2 were calculated. ITT population: all treated subjects with PGIC data available at Week 2.
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End point type |
Primary
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End point timeframe |
Week 2
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| Notes [3] - 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: Descriptive data were collected for this endpoint. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Number of Subjects With Treatment-emergent Adverse Events (TEAEs) [4] | |||||||||||||||||||||||||||||||||
End point description |
A TEAE was defined as any AE with an onset date that was on or after the first dose of study drug or any pre-existing condition that worsened in severity after the first dose of study drug. Safety population: all subjects who were randomized and received at least 1 dose of study treatment.
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End point type |
Primary
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End point timeframe |
Screening Visit (14 ± 3 days before Day 1) through Week 26; 2-Week (14 ± 3 days) Post-Dosing/End of Study Visit; serious adverse events (AEs) collected from signing of informed consent form, AEs collected from first dose of study treatment.
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| Notes [4] - 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: Descriptive data were collected for this endpoint. |
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| No statistical analyses for this end point | ||||||||||||||||||||||||||||||||||
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End point title |
Number of Subjects With Notable Changes in Hematology, Blood Chemistry, and Urinalysis [5] | ||||||||||||||||||
End point description |
The following laboratory tests were performed: hematology: hemoglobin, hematocrit, red blood cell count, white blood cell count (with differential), and platelet count; blood chemistry: sodium, potassium, chloride, total bilirubin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, lactate dehydrogenase, gamma-glutamyl transferase, blood urea nitrogen, creatinine, and bicarbonate; urinalysis: color, appearance, leukocyte esterase, specific gravity, pH, protein, glucose, blood, ketones, microscopy, and urine culture (if necessary to rule out infection); estimated creatinine clearance (using the Cockcroft-Gault formula); pregnancy testing for all female subjects of childbearing potential. Safety population: all subjects who were randomized and received at least 1 dose of study treatment.
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End point type |
Primary
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End point timeframe |
Screening Visit (14±3 days before Day 1) through Week 26; 2-Week (14±3 days) Post-Dosing/End of Study Visit
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| Notes [5] - 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: Descriptive data were collected for this endpoint. |
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Number of Subjects With Abnormalities in Vital Signs [6] | |||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Vital signs included supine systolic and diastolic blood pressure, pulse, and body temperature. The subject was to rest quietly for 5 minutes prior to blood pressure measurements. Safety population: all subjects who were randomized and received at least 1 dose of study treatment.
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End point type |
Primary
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End point timeframe |
Screening Visit (14 ± 3 days before Day 1) through Week 26; 2-Week (14 ± 3 days) Post-Dosing/End of Study Visit
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| Notes [6] - 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: Descriptive data were collected for this endpoint. |
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| No statistical analyses for this end point | ||||||||||||||||||||||||||||||||||||||||||||||||||||
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End point title |
Number of Subjects with Abnormal Electrocardiogram (ECG) Findings When Normal at Baseline [7] | |||||||||||||||
End point description |
ECG (12-lead reads) were performed after the subject had been resting quietly for at least 5 minutes. Safety population: all subjects who were randomized and received at least 1 dose of study treatment with a normal baseline ECG reading.
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End point type |
Primary
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End point timeframe |
Screening Visit (14±3 days before Day 1) through Week 26; 2-Week (14±3 days) Post-Dosing/End of Study Visit
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| Notes [7] - 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: Descriptive data were collected for this endpoint. |
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| No statistical analyses for this end point | ||||||||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
Screening Visit (14 ± 3 days before Day 1) through Week 26; 2-Week (14 ± 3 days) Post-Dosing/End of Study Visit; serious AEs collected from signing of informed consent form, AEs collected from first dose of study treatment.
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Assessment type |
Systematic | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
16.0
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Reporting groups
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Reporting group title |
Placebo
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Reporting group description |
Placebo tablet BID | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Fampridine 10 mg BID
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Reporting group description |
Prolonged-release fampridine 10 mg BID | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
