Phase 2 trial of sustained-release fampridine in chronic spinal cord injury.
METHODS
Double-blind, randomized, placebo-controlled, parallel-group clinical trial.


OBJECTIVE
Assess safety and efficacy of sustained-release fampridine in subjects with chronic spinal cord injury.


METHODS
A total of 11 academic rehabilitation research centers in the United States.


METHODS
A total of 91 subjects with motor-incomplete spinal cord injury (SCI), randomized to three arms: fampridine, sustained release, 25 mg b.i.d. (Group I), 40 mg b.i.d. (Group II), and placebo (Group III) for 8 weeks.


METHODS
Patient diary questionnaire, Ashworth score, American Spinal Cord Injury Association International Standards, International Index of Erectile Function, bladder and bowel management questionnaires, and Clinician and Subject Global Impressions (Clinician Global Impression of change, Subject Global Impression (SGI)). Safety was evaluated from adverse events, physical examinations, vital signs, electrocardiograms, and laboratory tests.


RESULTS
In total, 78% of the subjects completed the study. More (13/30) discontinued from Group II than Group I (4/30) and Group III (3/31). The most frequent adverse events across groups were hypertonia, generalized spasm, insomnia, dizziness, asthenia, pain, constipation, and headache. One subject in Group II experienced a seizure. SGI changed significantly in favor of Group I (P=0.02). Subgroup analysis of subjects with baseline Ashworth scores >1 showed significant improvement in spasticity in Group I versus III (P=0.02).


CONCLUSIONS
Group I showed significant improvement in SGI, and potential benefit on spasticity. The drug was well tolerated. Group II showed more adverse events and discontinuations.
Cardenas
D D
DD
Department of Rehabilitation Medicine, University of Washington, Seattle, WA, USA.
Ditunno
J
J
Graziani
V
V
Jackson
A B
AB
Lammertse
D
D
Potter
P
P
Sipski
M
M
Cohen
R
R
Blight
A R
AR
D015761:4-Aminopyridine / Q000627:therapeutic use*; D000328:Adult; D000368:Aged; D002908:Chronic Disease; D003692:Delayed-Action Preparations; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D026902:Potassium Channel Blockers / Q000627:therapeutic use*; D013119:Spinal Cord Injuries / Q000188:drug therapy*; D016896:Treatment Outcome
D003692:Delayed-Action Preparations; D026902:Potassium Channel Blockers; D015761:4-Aminopyridine