MS Forum Site of information

nani

A Phase 3, Multi-Center Trial of Oral, Sustained-Release Fampridine (4-Aminopyridine) in Multiple Sclerosis

Andrew Goodman, Steven Schwid, Rochester, NY, Theodore Brown, Seattle, WA, Lauren Krupp, Stony Brook, NY, Randall Schapiro, Golden Valley, MN, Lawrence Marinucci, Ron Cohen, Andrew Blight, Hawthorne, NY.

OBJECTIVE: To assess efficacy and safety of oral sustained release fampridine (Fampridine-SR) in patients with multiple sclerosis (MS).

BACKGROUND: Prior studies of fampridine in MS have reported beneficial effects on motor function, including ambulation. This study was designed to confirm such effects and to validate their clinical meaningfulness.

DESIGN/METHODS: Randomized, double-blind, placebo-controlled, parallel-group study comparing 10 mg fampridine bid and placebo (3:1 ratio). A 2-week placebo run-in was followed by a 14 week treatment period, and a 4 week follow-up period. Eligibility criteria included: definite MS diagnosis, with any type of MS clinical course; age 18-70; completion of the Timed 25-Foot Walk (T25FW) within 8-45 seconds at screening; concomitant medications permitted on a stable regimen throughout trial.

The primary outcome measure was the proportion of responders with consistent improvement in walking speed on the T25FW during the treatment period. The Multiple Sclerosis Walking Scale 12 (MSWS-12) was used to assess clinical meaningfulness.

RESULTS: 301 patients were randomized; 229 received fampridine and 72 placebo. 283 patients completed the trial (n = 212, 71). The fampridine-treated group had a higher proportion of responders, compared to the placebo group (34.8 % v. 8.3 %; p < 0.001). Response rates were higher across all clinical course types. Improvement in walking speed was consistent through the 14 week treatment period among patients who responded to fampridine and remained significantly different from placebo after 14 weeks (p < 0.001).

Responders v. non-responders showed significant improvement in the MSWS-12 (p < 0.001). Adverse events were similar to those observed in previous studies of fampridine in MS. Two serious adverse events attributed to fampridine that led to discontinuation were anxiety in one participant and a seizure during a period of urosepsis in another.

CONCLUSIONS/RELEVANCE: A significant proportion of MS patients treated with fampridine experienced consistently improved walking speed during 14 weeks of treatment. Improvement in the MSWS-12 score among responders appears to validate the clinical meaningfulness of this improvement.

Supported by: Acorda Therapeutics Inc., Hawthorne, NY.

_________________
Welcome to my info site, as I call it. I have Multiple Sclerosis in secondary progression stage. I post what I find useful and hope you can help out with a donation of $1 if you can. If not it's ok... thanks Nani