A study of MK-0974 in prevention of menstrually related migraine (065)

• Research type

  Research Study

• Full title

  A Six Month Phase II/III, Randomised, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of Telcagepant (MK0974) for Prevention of Menstrually Related Migraine in Female Patients with Episodic Migraine

• IRAS ID

  50863

• Contact name

  Paul Robinson

• Sponsor organisation

  Merck Sharp & Dohme Corp.

• Eudract number

  2010-019288-13

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  The aim of the study is to assess the safety, side effects and effectiveness of an experimental drug MK0974 (also known as telcagepant) when taken to prevent menstrually related migraines. Migraine is estimated to affect 10% of the UK population and migraine is 3 to 4 times more common in women than men. Attacks usually last between 4 and 72 hours with symptoms including intense headache, nausea, vomiting, and sensitivity to light, sound or smell. The frequency of attacks varies, from infrequent to multiple attacks per month. It can have a significant effect on the sufferer's quality of life. Migraine attacks that occur during a women??s menstrual period are typically more severe, last longer, and are more likely to recur the next day than non-menstrual attacks. MK0974 inhibits the action of a brain chemical that is associated with triggering migraine attacks and it is thought that MK0974 may be effective at preventing menstrually related migraine. Eligible patients are women = 18 years or older, in good physical health who experience =2 migraine attacks per month, have regular menstrual cycles and report headache during menstrual period in at least 2 out of 3 cycles. Approximately 4500 patients worldwide will receive either MK0974 or placebo over a 6 month period. Patients will take a single dose of study medication for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Patients will need to attend the research site on 7 occasions. The research is being funded by the pharmaceutical company that is developing the study drug Within the UK it is anticipate that 3 research sites will participate in the study.

• REC name

  London - City & East Research Ethics Committee

• REC reference

  10/H0703/46

• Date of REC Opinion

  24 Jun 2010

• REC opinion

  Further Information Favourable Opinion