Fampridine-SR in multiple sclerosis: a randomized, double-blind, placebo-controlled, dose-ranging study

Area of Science:

• Neurology
• Pharmacology

Background:

• Multiple Sclerosis (MS) is a chronic neurological disease affecting the central nervous system.
• Current treatments for MS focus on managing symptoms and slowing disease progression.

Purpose of the Study:

• To evaluate the safety and dose-related efficacy of sustained-release 4-aminopyridine (Fampridine-SR) in multiple sclerosis (MS) patients.
• To determine optimal dosage for potential therapeutic benefits.

Main Methods:

• A multicenter, randomized, double-blind, placebo-controlled study was conducted.
• Participants received Fampridine-SR (10-40 mg twice daily) or placebo.
• Assessments included the MS Functional Composite (MSFC), fatigue questionnaires, and muscle strength testing.

Main Results:

• Fampridine-SR showed improvements in lower extremity muscle strength and walking speed compared to placebo.
• Common adverse events included dizziness, insomnia, and headache.
• Higher doses (above 25 mg twice daily) were associated with increased adverse events, including convulsions in two subjects.

Conclusions:

• Doses up to 20 mg twice daily may be suitable for future studies.
• Lower extremity strength and walking speed are promising outcome measures for Fampridine-SR in MS.
• Careful dose titration is recommended to balance efficacy and safety.