a multicenter, double blind, placebo and active controlled, parallel group study to compare the efficacy and safety of oral Mk 0974 with placebo and zolmitriptan for the acute treatment of migraine with or without aura - mk 0974-011
- Conditions
- patients with migraineMedDRA version: 6.1Level: PTClassification code 10027599
- Registration Number
- EUCTR2006-004257-14-IT
- Lead Sponsor
- MERCK SHARP DOHME
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1800
Inclusion Criteria
1.Patient is 18-65 years of age at screening 2.Patient has had a history of migraine with or without aura
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
1.Patient is pregnant 2. Patient has difficulty distinguishing his/her migraine attacks 3.Patient has history of mild migraine 4.Patient has basilar or hemiplegic migraine headache 5.Patient has more than 15 headache days per month 6.Patient is taking migraine prophylactic medication where teh prescribed daily dose has changed during the 3 months prior to screening
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: to evaluate the efficacy and safety of mk 0974 compared to placebo and zolmitriptan in the treatment of acute migraine;Secondary Objective: to evalutae the efficacy and safety of Mk 0974 compared to placebo and zolmitriptan in the treatment of acute migraine;Primary end point(s): --------------------
- Secondary Outcome Measures
Name Time Method