Sustained-Release Fampridine Improves Walking and Leg Strength in Patients With Multiple Sclerosis: Presented at WCTRMS

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Title: Sustained-Release Fampridine Improves Walking and Leg Strength in Patients With Multiple Sclerosis: Presented at WCTRMS
URL: http://www.pslgroup.com/dg/22D3AE.htm
Doctor's Guide
September 22, 2008

By Louise Gagnon

MONTREAL -- September 22, 2008 -- Sustained-release fampridine improves walking and leg strength in patients with multiple sclerosis, according to data from a phase 3 study presented here at the World Congress on Treatment and Research in Multiple Sclerosis (WCTRMS).

The study found that therapy with fampridine resulted in consistently improved walking speed during the treatment period. Subjects had various subtypes of multiple sclerosis, including relapsing-remitting, primary-progressive, secondary-progressive, and progressive-relapsing.

"These patients have a lot of problems with walking and significant problems with leg strength," explained co-investigator Andrew Goodman, MD, University of Rochester, Rochester, New York, speaking at a late-breaking poster session here on September 20. "I suspect that it will help patients the most who say they walk for about 5 minutes and then … need to sit down," said Dr. Goodman.

Dr. Goodman noted that in a previous phase 3 study with fampridine, beneficial impact was observed in patients' ambulation and leg strength.

The current study initially randomised 239 adult patients (aged 18 to 70 years) to 10 mg fampridine twice daily (n = 120) or placebo (n = 119). Patients had a 2-week placebo run-in period, followed by 9 weeks of treatment and 2 weeks of follow-up. Individuals were eligible to participate if they had completed the Timed 25-Foot Walk (T25FW) within 8 to 45 seconds at baseline.

A total of 227 patients (113 on fampridine and 114 on placebo) completed the trial.

Patients treated with fampridine had a significantly higher proportion of Timed Walk Responders compared to those on placebo (42.9% vs 9.3%, P < .001). Walking speed in Timed Walk Responders increased by about 25% from baseline over 8 weeks for treated subjects. In addition, leg strength, which was measured by the Lower Extremity Manual Muscle Test, showed more progress in Timed Walk Responders than in placebo patients (P = .028).

"Some people see a response in a couple of days, and with some patients the response takes longer," said Dr. Goodman, discussing the sustainability of response. "You can't assume there isn't a response if you don't see it in a couple of days."

There were a total of 3 serious adverse events that led to study withdrawal, one of which, a patellar fracture, occurred in the treatment arm.

Additionally, there was an imbalance in the incidence of urinary tract infections (UTIs), with 10 infections (8.4%) occurring in patients on placebo and 21 (17.5%) occurring in patients on the active therapy. "More women were randomised to fampridine, and that [difference] might be expected, since women are clearly more prone to UTIs," Dr. Goodman commented.

Women in the study made up 62.2% of patients on placebo (74 of 119) and 73.3% of patients on fampridine (88 of 120).

Funding for this study was provided by Acorda Therapeutics, Inc..

[Presentation title: Sustained-Release Fampridine Consistently Improves Walking Speed and Leg Strength in Multiple Sclerosis: A Phase III Trial. Abstract P909]

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