Safety and Efficacy Study of Oral Fampridine-SR in Patients With Multiple Sclerosis

Acorda Therapeutics

Status and phase: Completed; Phase 2

Conditions: Multiple Sclerosis

Treatments: Drug: 15 mg fampridine-SR (4-aminopyridine, 4-AP); Drug: 10 milligram (mg) fampridine-SR (4-aminopyridine, 4-AP); Drug: 20 mg fampridine-SR (4-aminopyridine, 4-AP); Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00053417

MS-F202

Details and patient eligibility

About

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.

Enrollment: 206 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have a confirmed diagnosis of Multiple Sclerosis
• Are able to walk with or without an assisted 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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206 participants in 4 patient groups, including a placebo group

1

Placebo Comparator group

Description:

Placebo control, twice a day (b.i.d.)

Treatment:

Drug: Placebo

2

Experimental group

Description:

10 milligram (mg) fampridine b.i.d.

Treatment:

Drug: 10 milligram (mg) fampridine-SR (4-aminopyridine, 4-AP)

3

Experimental group

Description:

15 mg fampridine b.i.d.

Treatment:

Drug: 15 mg fampridine-SR (4-aminopyridine, 4-AP)

4

Experimental group

Description:

20 mg fampridine b.i.d.

Treatment:

Drug: 20 mg fampridine-SR (4-aminopyridine, 4-AP)