Pediatric Headache
Study Name: TXA107979: A Randomized, Multicenter, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of a Combination Product Containing Sumatriptan and Naproxen Sodium for the Acute Treatment of Migraine in Adolescents
Primary Investigator: A. David Rothner, MD 216.444.5514
Trial Description: Adolescents suffering from migraine attacks may not be able to participate in their normal activities. In an effort to reduce the burden of migraine headaches in this population, many clinical trials have evaluated the use of triptan therapy in adolescent migraine. To date, these studies to evaluate the use of triptans have failed to provide sufficient evidence to secure regulatory approval in the US for treatment of adolescents. Several factors may account for the failure of triptan treatment to achieve statistical significance in this population, as compared to adults. Differences include the symptom patterns and duration of migraine attacks in this population and study design issues (for example high placebo response rates, or selection of primary endpoint). As a consequence, there are no FDA-approved treatment options available for adolescents who have migraine.
This phase IIIB study will evaluate the efficacy, and safety of a range of doses of a combination product, sumatriptan and naproxen sodium (10 mg/60 mg, 30 mg/180 mg, 85 mg/500 mg), for the acute treatment of migraine (with moderate or severe pain) in adolescents ages 12 through 17 years old.
Entry Requirements: Subjects must meet IHS criteria for migraine with or without aura and all other inclusion and exclusion criteria. Attacks should last a minimum of three hours and be associated with moderate to severe headache pain.
For more information, contact Diane Davies, Research Nurse, at 216.444.0173.
