Phase 3
N=636
Efficacy and Safety Study of Prolonged-Release Fampridine in Participants With Multiple Sclerosis
Multiple Sclerosis
Bottom Line
View on ClinicalTrials.gov: NCT02219932 ↗Enrolled (actual)
636
Serious AEs
7.2%
Results posted
Mar 2017
Primary outcome: Primary: Proportion of Participants Achieving a Mean Improvement of ≥ 8 Points From Baseline on the Multiple Sclerosis Walking Scale (MSWS-12) Over 24 Weeks — 0.336; 0.432 proportion of participants — p=0.006
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- fampridine (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Biogen
- Primary completion
- Feb 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Participants Achieving a Mean Improvement of ≥ 8 Points From Baseline on the Multiple Sclerosis Walking Scale (MSWS-12) Over 24 Weeks |
0.336; 0.432 | 0.006 sig |
| SECONDARY Proportion of Participants Achieving a Mean Improvement From Baseline of ≥ 15% in Timed Up and Go (TUG) Speed Over 24 Weeks |
0.347; 0.434 | 0.030 sig |
| SECONDARY Change From Baseline in Multiple Sclerosis Impact Scale-29 (MSIS-29) Physical Score Over 24 Weeks |
-4.68; -8.00 | < 0.001 sig |
| SECONDARY Change From Baseline in Berg Balance Scale (BBS) Over 24 Weeks |
1.34; 1.75 | 0.141 |
| SECONDARY Change From Baseline in ABILHAND Score Over 24 Weeks |
0.75; 1.49 | 0.197 |
Summary
The primary objective is to determine whether prolonged-release fampridine (10 mg twice daily) has a clinically meaningful effect on participant-reported walking ability over a 24-week study period.
The secondary objectives are: to determine whether prolonged-release fampridine 10 mg taken twice daily (BID) has a clinically meaningful effect on dynamic and static balance, physical impact of multiple sclerosis (MS), and upper extremity function over a 24-week study period; to evaluate criteria for early assessment of response to fampridine that can predict clinically meaningful benefits in walking ability and balance; to assess the safety and tolerability of prolonged-release fampridine 10 mg twice daily over a 24-week treatment period.
Eligibility Criteria
Key Inclusion Criteria
- Must have a diagnosis of primary-progressive, secondary-progressive, progressive-relapsing, or relapsing-remitting MS per revised McDonald Committee criteria [McDonald 2001; Polman 2005] as defined by Lublin and Reingold [Lublin and Reingold 1996] of at least 3 months duration
- Must have an Expanded Disability Status Scale (EDSS) score of 4 to 7, inclusive
- Must have walking impairment, as deemed by the Investigator
Key Exclusion Criteria
- History of human immunodeficiency virus (HIV)
- Presence of acute or chronic hepatitis. Subjects who have evidence of prior hepatitis infection that has been serologically confirmed as resolved are not excluded from study participation
- Known allergy to fampridine, pyridine-containing substances, or any of the inactive ingredients in the prolonged-release fampridine tablet
- Creatinine clearance (CrCl) of <80 mL/min
- History of malignant disease
- Presence of pulmonary disease
- A body mass index (BMI) ≥40 (BMI formula: BMI = mass [kg]/[height(m)]2)
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02219932). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.