1246.4 BI 44370 in acute migraine

• Research type

  Research Study

• Full title

  A randomised, double-blind, placebo- and active comparator-controlled, five parallel groups study to investigate the efficacy and safety of BI 44370 TA (50mg, 200mg, and 400mg) administered orally once during an acute migraine attack of moderate or severe intensity

• IRAS ID

  4957

• Contact name

  Bohehringer Ingelheim Study Co-ordinator

• Sponsor organisation

  Boehringer Ingelheim

• Eudract number

  2008-000079-31

• ISRCTN Number

  n/a

• Research summary

  Migraine is a condition of major public health concern, as approximately 12% of the population suffer from recurrent migraine attacks that interfere with their daily lives. Migraine sufferers perceive a wide range of treatment needs that are not fully met by currently available therapies. These include a faster onset of action, a lower incidence of drug-induced side effects, and an improvement of response rate and relapse rate (up to 40% of initial responders suffer from recurrent headaches within several hours). BI 44370 is a novel putative drug which is expected to show a beneficial effect on the pain of an acute migraine attack with a rapid onset of action and good tolerability, without having the cardiovascular effects of certain other marketed medicines for migraine (called triptans). This study, which lasts 9 weeks, will evaluate the safety and effectiveness of BI 44370 TA (TA = tartaric acid) taken orally once during an acute migraine attack of moderate or severe intensity. The trial will be performed in migraine centres in Europe.

• REC name

  South Central - Oxford B Research Ethics Committee

• REC reference

  08/H0605/117

• Date of REC Opinion

  1 Oct 2008

• REC opinion

  Further Information Favourable Opinion