Study of Oral Fampridine-SR in Multiple Sclerosis

Study Overview
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Brief Summary
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To assess the safety and efficacy of 10 milligram (mg) twice a day (b.i.d.) Fampridine-SR in patients diagnosed with multiple sclerosis (MS), in a double-blind, placebo-controlled, parallel group study.

Detailed Description
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Multiple sclerosis (MS) is a disorder of the body's immune system that affects the central nervous system (CNS). Normally, nerve fibers carry electrical impulses through the spinal cord, providing communication between the brain and the arms and legs. In people with MS, the fatty sheath that surrounds and insulates the nerve fibers (called myelin) deteriorates, causing nerve impulses to be slowed or stopped. As a result, patients with MS may experience periods of muscle weakness and other symptoms such as numbness, loss of vision, loss of coordination, paralysis, spasticity, mental and physical fatigue and a decrease in the ability to think and/or remember. These periods of illness may come (exacerbations) and go (remissions). Fampridine-SR is an experimental drug that has been reported to possibly improve muscle strength and walking ability for some people with MS. This study will evaluate the effects and possible risks of taking Fampridine-SR in subjects with MS.

Official Title
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Double-Blind, Placebo-Controlled, 21-Week, Parallel Group Study to Evaluate Safety and Efficacy of Oral Fampridine-SR in Subjects With Multiple Sclerosis

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Drug: Fampridine-SR
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have a confirmed diagnosis of multiple sclerosis Are able to walk with or without an assistive device Exclusion Criteria: Pregnancy, breastfeeding or females of childbearing potential not using adequate birth control Participating in other investigational drug trials A medical history or clinical findings that preclude entry into the study A medication history that precludes entry into the study Previously treated with 4-aminopyridine (4-AP)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo- sugar pill<br>Placebo control | Drug: Placebo<br>* sugar pill, twice a day (b.i.d.)<br>|
| Experimental: Fampridine-SR<br>10 milligram (mg) tablet b.i.d. | Drug: Fampridine-SR<br>* Tablets, 10 mg, twice daily, 14 weeks<br>* Other names: Sustained release 4-aminopyridine, 4-AP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Timed Walk Responders (Patients Who Showed Consistent Improvement on the Timed-25 Foot Walk) | Patients who showed a faster walking speed for at least three of the four on-drug visits during the double-blind treatment period as compared to the maximum speed for any of the five off-drug visits. | Days 14, 42, 70 and 98 of treatment, corresponding to the four on-drug visits during double-blind treatment period. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lower Extremity Manual Muscle Test; Ashworth Score for Spasticity |  | Days 14, 42, 70, 98 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Walking Ability