Last updated on July 2010


Brief description of study


Detailed Study Description

Have you suffered from at least 2 migraines per month for at least 3 months or more? Are you female, at least 18 years of age? Have you suffered from headaches during your last 2 or 3 menstrual cycles? If so, you may qualify to participate in a research study of an investigational drug to see if it can help prevent related migraines. For more information, please call: Diablo Clinical Research at 925-930-7267 Or visit our website at

Inclusion Criteria:

  • Patient who has had regular menstrual cycles monthly (22 to 32 days) for at least the last 3 cycles
  • Patient experiences headache during menstrual period in at least 2 out of last 3 cycles
  • Patient has history of migraine for = 3 months and with = 2 migraine attacks per month in the 2 months prior to screening
  • Patient agrees to use an effective method of birth control through the duration of the study

Exclusion Criteria:

  • Patient has basilar or hemiplegic migraine headache
  • Patient has taken medication for acute headache on more than 15 days per month in the 3 months prior to screening
  • Patient is taking prophylactic medication for migraine and daily dose has changed with in 4 weeks prior to screening
  • Patient has history of significant liver disease
  • Patient has had cardiac surgery or symptoms with in 3 months of screening
  • Patient has confounding pain syndromes, psychiatric conditions, dementia, or major neurological disorders other than migraine
  • Patient has history of neoplastic disease = 5 years prior to signing informed consent
  • Patient has history of gastric or small intestinal surgery
  • Patient consumes 3 or more alcoholic drinks per day

Clinical Study Identifier: TX134954

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