Topiramate intervention to prevent transformation of episodic migraine: the topiramate INTREPID study.
OBJECTIVE
The study sought to evaluate whether topiramate prevents development of chronic daily headache (CDH, ≥15 headache days per month) in adult subjects with high-frequency episodic migraine (HFEM, 9-14 migraine headache days/month). A secondary objective was to assess the efficacy of topiramate as preventive migraine treatment in this population.


METHODS
This was a multicenter, randomized, double-blind, placebo-controlled study comparing topiramate 100 mg/day and placebo for 26 weeks. The primary efficacy variable was new-onset CDH at month 6. Secondary efficacy measures included migraine and headache days. Adverse events (AEs) were evaluated.


RESULTS
A total of 159 topiramate subjects and 171 placebo subjects were efficacy-evaluable. At month 6, 1.4% of topiramate subjects versus 2.3% of placebo subjects had CDH (p = .589). Compared with placebo, topiramate treatment was associated with statistically significant reductions in mean number of migraine days (6.6 vs. 5.3/28 days; p = .001) and headache days (6.6 vs 5.3/28 days; p = .001). Most commonly reported AEs in the topiramate versus placebo group included paresthesia (32.4% vs. 7.0%), fatigue (14.8% vs. 8.6%), dizziness (11.4% vs. 7.6%) and nausea (10.8% vs. 9.2%).


CONCLUSIONS
Topiramate 100 mg/day did not prevent the development of CDH at six months in subjects with HFEM. Topiramate was effective in reducing headache days and migraine headache days and generally well tolerated.
Lipton
Richard B
RB
Montefiore Headache Center and Department ofNeurology, Albert Einstein College of Medicine, 1165 Morris Park Ave., Bronx, NY 10461, USA. richard.lipton@einstein.yu.edu
Silberstein
Stephen
S
Dodick
David
D
Cady
Roger
R
Freitag
Fred
F
Mathew
Ninan
N
Biondi
David M
DM
Ascher
Steven
S
Olson
William H
WH
Hulihan
Joseph
J
D000328:Adult; D004311:Double-Blind Method; D005260:Female; D005632:Fructose / Q000031:analogs & derivatives* / Q000627:therapeutic use; D020773:Headache Disorders / Q000517:prevention & control; D006801:Humans; D008297:Male; D008881:Migraine Disorders / Q000517:prevention & control*; D018696:Neuroprotective Agents / Q000627:therapeutic use*; D000077236:Topiramate; D016896:Treatment Outcome
D018696:Neuroprotective Agents; D000077236:Topiramate; D005632:Fructose