Conditions: Multiple Sclerosis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 430
Healthy volunteers: no

Brief summary:
The purpose of this study is to investigate the safety and efficacy of a lower dose of dalfampridine extended release tablets compared to the currently approved dose in improving walking in Multiple Sclerosis (MS) patients.

Detailed description:
The current study is designed as a prospective placebo-controlled trial to investigate the safety and efficacy of a lower dose of dalfampridine extended release tablets (5 mg twice daily) compared to the approved commercial dose of 10 mg twice daily in improving walking in MS patients during a four-week period of treatment.

Arms:
arm 1: 5mg, twice daily arm 2: 10mg, twice daily arm 3: placebo, twice daily

Interventions: intervention 1: Dalfampridine-ER 5mg intervention 2: Dalfampridine-ER 10mg intervention 3: Placebo
Intervention descriptions: intervention 1: 5mg, twice daily intervention 2: 10mg, twice daily intervention 3: placebo, twice daily

Protocol document: