Please login to the form below

Not currently logged in
Email:
Password:

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.

8th July 2010

Share

PMEA Awards 2020

COVID-19 Updates and Daily News

Featured jobs

PMHub

Add my company
IGNIFI

We’re IGNIFI. An independent creative agency, we help spark and sustain successful brands for some of the biggest names in...

Latest intelligence

What’s in it for me? How to engage, motivate and support staff with internal training at OPEN Health
...
Environmental impact of in-person vs. virtual meetings
Although it will be tempting to resume in-person activities in the same capacity as before, we need to weigh the pros and cons of virtual vs. in-person vs. hybrid events...
US biosimilars
The US celebrates five years of biosimilars on the market – a look to the past, present and future
Why the success of biosimilars in the US has been mixed...

Infographics