Conditions: Multiple Sclerosis
Keywords: Walking Ability Muscle strength Spasticity
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 206
Healthy volunteers: no

Brief summary:
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 (Sustained Release, SR) is an experimental drug that increases the ability of the nerve to conduct electrical impulses. This study will evaluate the effects of Fampridine-SR on the walking ability of subjects with MS, as well as to examine the effects on muscle strength and spasticity. The study will also examine the possible risks of taking Fampridine-SR.

Detailed description:

Arms:
arm 1: Placebo control, twice a day (b.i.d.) arm 2: 10 milligram (mg) fampridine b.i.d. arm 3: 15 mg fampridine b.i.d. arm 4: 20 mg fampridine b.i.d.

Interventions: intervention 1: Placebo intervention 2: 10 milligram (mg) fampridine-SR (4-aminopyridine, 4-AP) intervention 3: 15 mg fampridine-SR (4-aminopyridine, 4-AP) intervention 4: 20 mg fampridine-SR (4-aminopyridine, 4-AP)
Intervention descriptions: intervention 1: Placebo for 15 weeks intervention 2: 2 week up titration (10 mg)

12 weeks stable dose (10 mg)

1 week down titration (10 mg) intervention 3: 10 mg twice daily for 1 week

15 mg twice daily for 14 weeks

2 week up titration (10 mg x 1 week, 15 mg x 1 week)

12 weeks stable dose (15 mg)

1 week down titration (10 mg) intervention 4: 2 week up titration (10 mg x 1 week, 15 mg x 1 week)

12 weeks stable dose (20 mg)

1 week down titration (15 mg x 3 days, 10 mg x 4 days)

Protocol document: