Gabapentin in the prophylaxis of chronic daily headache: a randomized, placebo-controlled study.

Abstract

To compare efficacy and safety of gabapentin (GPT) versus placebo for prophylaxis of chronic daily headache (CDH) (headache at least 15 days/month of greater than 4 hours duration over preceding 6 months). This is a multicenter randomized placebo-controlled crossover study. After 4-week baseline, subjects, aged 18 to 65, were randomized to GPT 2,400 mg/day or placebo. There was 2 weeks titration, 6-week stable dosage, and 1 week washout period between treatment arms. The primary efficacy measure was the difference between the percentage of headache-free days per treatment period. Secondary efficacy measures included headache duration and severity, degree of disability, associated symptoms, concomitant medications, Visual Analogue Scale (VAS) scores, and quality of life (QOL). A total of 133 patients were enrolled (41 men, 92 women, mean age 43 years). All were eligible for safety analysis. Ninety-five received sufficient treatment to allow evaluation of efficacy. There was a 9.1% difference in headache-free rates favoring GPT over placebo (p = 0.0005). Benefits for GPT were also demonstrated for headache-free days/month (p = 0.0005), severity (p = 0.03), VAS (p = 0.0006), headache-associated symptoms of nausea (p = 0.03) and photophobia/phonophobia (p = 0.04), disability affecting normal activities (p = 0.02), attacks requiring bed rest (p = 0.001), and QOL related to bodily function (p = 0.01), health/vitality (p = 0.0001), social function (p = 0.006), and health transition (p = 0.0002). Reduction in headache days/month was seen across the spectrum of prerandomization headache frequencies. Gabapentin represents a therapeutic option for chronic daily headache.