An Open-Label, Multicenter, Multinational Study to Assess the Effect of Long Term Prolonged Release Fampridine (BIIB041) 10 mg Twice Daily on Quality of Life as Reported by Subjects with Multiple Sclerosis
- Conditions
- Plaques in central nervous system10007951
- Registration Number
- NL-OMON37416
- Lead Sponsor
- Biogen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 90
1. Male or female subjects, 18 to 75 years old, inclusive, at the time of informed consent.
2. Must have a diagnosis of primary progressive, secondary progressive, progressive remitting, or relapsing remitting MS per revised McDonald Committee criteria as defined by Lublin and Reingold of at least 3 months duration.
3. Have a walking impairment as determined by the Investigator.
4. Able to perform the T25FW test with or without a walking aid.
5. Female subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 30 days after their last dose of study treatment.
1. Known allergy to pyridine-containing substances or to any of the inactive ingredients in the prolonged release fampridine tablet.
2. Any history of seizure, epilepsy, or other convulsive disorder, with the exception of febrile seizures in childhood.
3. An estimated CrCl of <80 mL/minute.
4.Subject needs to take medicinal products that are inhibitors of organic cation transporter 2 (OCT2 [e.g., cimetidine]).
5.Previous exposure to fampridine.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>• Change from baseline in the PCS of the SF 36 measured over Months 3, 6, 9,<br /><br>and 12 among subjects who respond to treatment with prolonged release<br /><br>fampridine. </p><br>
- Secondary Outcome Measures
Name Time Method