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GSK migraine study fails
A phase IIb study of a migraine prophylaxis has failed to show that the drug was better than placebo at preventing headaches
A phase IIb clinical study of a migraine prophylaxis being developed by GlaxoSmithKline through a partnership with XenoPort failed to show that the drug was better than placebo at preventing headaches, according to the companies.
The drug, gabapentin enacarbil (GSK1838262/XP13512), is a new chemical entity that provides dose-proportional, sustained exposure of gabapentin using high-capacity transport mechanisms in the gastrointestinal tract. The partners are also developing the product as a treatment for restless leg syndrome and have already submitted a US marketing application for that indication.
The 30-week dose-ranging migraine trial enrolled 526 adults diagnosed with migraine headache with or without aura. Patients received 1,200, 1,800, 2,400 or 3,000 mg twice daily of the experimental drug or placebo. The drug failed to demonstrate statistically significant improvement vs. placebo for the study's primary endpoint, which was the change from baseline in the number of migraine headache days during the last four weeks of treatment prior to taper.
GSK and XenoPort hypothesized that the failure may have been due to the "unexpectedly high" placebo response rather than to a lack of efficacy of the experimental treatment. XenoPort suggested that development of the drug for the migraine indication would likely continue, saying the company "remains committed to working with our partners and regulatory authorities to make this product candidate available to patients with unmet medical needs."
Two patients taking the study drug died during the trial and six more experienced serious adverse events. One of the deaths was caused by bronchopneumonia and was deemed unrelated to the trial, while the other was an accidental overdose of medications other than the study drug, "but the relationship of this event to the study drug could not be established," according to GSK.
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