Two phase 3, multicenter, randomized, placebo-controlled clinical trials of fampridine-SR for treatment of spasticity in chronic spinal cord injury.

Abstract

STUDY DESIGN:

Two randomized, double-blind, placebo-controlled trials.

OBJECTIVE:

To evaluate the efficacy and safety of fampridine sustained-release tablets (fampridine-SR) 25 mg twice daily for moderate-to-severe spasticity in patients with chronic spinal cord injury (SCI).

SETTING:

United States and Canada.

METHODS:

Patients with incomplete chronic SCI were randomized to twice daily fampridine-SR 25 mg or placebo, with a 2-week single-blind placebo run-in, a 2-week titration, 12 weeks of stable dosing, 2 weeks of downward titration and 2 weeks of untreated follow-up. Co-primary end points were the change from baseline, averaged over the double-blind treatment period, for Ashworth score (bilateral knee flexors and extensors) and a 7-point Subject Global Impression of treatment (SGI; 1, terrible; 7, delighted). Secondary end points were: Penn Spasm Frequency Scale; the motor/sensory score from the International Standards for Neurological Classification of SCI; Clinician's Global Impression of Change of neurological status; and the International Index of Erectile Function (men) or the Female Sexual Function Index (women).

RESULTS:

The populations were 212 and 203 patients in the two studies, respectively. Changes from baseline in Ashworth score were -0.15 (placebo) and -0.19 (fampridine-SR) in the first study, and -0.16 (placebo) and -0.28 (fampridine-SR) in the second study. The between-treatment difference was not significant for either the Ashworth score or the SGI and, with few exceptions, neither were the secondary end points. Fampridine-SR was generally well tolerated; treatment-emergent adverse events (TEAEs) and serious TEAEs were reported with similar frequency between treatments.

CONCLUSION:

Fampridine-SR was well tolerated. No significant differences were observed between treatment groups for the primary end points of Ashworth score and SGI.

• Authors: D D Cardenas, J F Ditunno, V Graziani, A B McLain, D P Lammertse, P J Potter, M S Alexander, R Cohen, A R Blight
• Journal: Spinal cord (Spinal Cord) Vol. 52 Issue 1 Pg. 70-6 (Jan 2014) ISSN: 1476-5624 [Electronic] England
• PMID: 24216616 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Potassium Channel Blockers
• 4-Aminopyridine

Topics

• 4-Aminopyridine (therapeutic use)
• Adult
• Canada
• Double-Blind Method
• Female
• Humans
• Male
• Muscle Spasticity (drug therapy, etiology)
• Potassium Channel Blockers (therapeutic use)
• Spinal Cord Injuries (complications, drug therapy)
• Treatment Outcome
• United States