Botulinum toxin type A and divalproex sodium for prophylactic treatment of episodic or chronic migraine.
OBJECTIVE
To compare the efficacy and safety of botulinum toxin type A (BoNTA; BOTOX: Allergan, Inc.) and divalproex sodium (DVPX; DEPAKOTE: Abbott Laboratories) as prophylaxis in reducing disability and impact associated with migraine.


BACKGROUND
There is a need for effective, well-tolerated prophylactic treatment of migraine.


METHODS
This was a randomized, double-blind, single-center prospective study. Fifty-nine patients received either BoNTA 100 U/placebo-DVPX bid or placebo-BoNTA/DVPX 250 mg bid. BoNTA/placebo injections were given at Day 0 and at Month 3. Patients were evaluated at Months 1, 3, 6, and 9.


RESULTS
Both treatments showed significant improvements in migraine disability scores and reductions in headache days and headache index. A trend to decreased headache severity was observed with BoNTA. A greater percentage of DVPX patients reported adverse events possibly related to treatment (DVPX 75.8% vs BoNTA 50%, P = .04) and discontinued because of adverse events (DVPX 27.6% vs BoNTA 3.3%, P = .012).


CONCLUSIONS
Both BoNTA and DVPX significantly reduced disability associated with migraine; BoNTA had a favorable tolerability profile compared with DVPX.
Blumenfeld
Andrew M
AM
The Neurology Center, Encinitas, CA 92024, USA.
Schim
Jack D
JD
Chippendale
Thomas J
TJ
D000293:Adolescent; D000328:Adult; D000368:Aged; D019274:Botulinum Toxins, Type A / Q000627:therapeutic use*; D002908:Chronic Disease; D004185:Disability Evaluation; D004311:Double-Blind Method; D004341:Drug Evaluation; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D018682:GABA Agents / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D008881:Migraine Disorders / Q000188:drug therapy*; D009465:Neuromuscular Agents / Q000627:therapeutic use*; D012189:Retrospective Studies; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome; D014635:Valproic Acid / Q000627:therapeutic use*
D018682:GABA Agents; D009465:Neuromuscular Agents; D014635:Valproic Acid; D019274:Botulinum Toxins, Type A