| April 17, 2008 |
| September 11, 2009 |
| March 2008 |
| September 2009 (final data collection date for primary outcome measure) |
| To evaluate the efficacy of MK0974 compared to placebo in the treatment of acute migraine in patients with stable vascular disease, as measured by pain freedom at 2 hours post dose. [ Time Frame: 2 hours post dose ] [ Designated as safety issue: No ] |
| Same as current |
| Complete list of historical versions of study NCT00662818 on ClinicalTrials.gov Archive Site |
| To evaluate the safety and tolerability of MK0974 compared to acetaminophen/paracetamol in the treatment of acute migraine in patients with stable vascular disease following 12 weeks of treatment. [ Time Frame: following 12 weeks of treatment ] [ Designated as safety issue: Yes ] |
| Same as current |
| |
| Treatment of Migraine in Patients With Stable Vascular Disease |
| A Multicenter, Randomized, Double-Blind, Placebo- and Active Controlled, Crossover Study to Evaluate the Safety and Efficacy of MK0974 in the Treatment of Acute Migraine in Patients With Stable Vascular Disease |
The purpose of this study is to evaluate the safety and efficacy of MK0974 in the treatment of acute migraine in patients with stable vascular disease. |
| |
| Phase III |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Safety/Efficacy Study |
- Migraine Disorders
- Heart Disease
- Cerebrovascular Accident
- TIA (Transient Ischemic Attack)
- Vascular Diseases
- Peripheral Vascular Diseases
|
- Drug: MK0974
- Drug: Comparator: acetaminophen
- Drug: Comparator: Placebo
|
- Active Comparator: Crossover study: All migraine attacks to be treated with up to 12 doses of MK0974 over the 1st six week treatment period. This will be followed by up to 12 doses of acetaminophen/paracetamol (1000mg dry filled capsules) over the 2nd six week treatment period.
- Active Comparator: Crossover study: All migraine attacks to be treated with one dose of placebo and up to 11 doses of acetaminophen over the 1st six week treatment period. This will be followed by up to 12 doses of MK0974 over the 2nd six week treatment period.
|
| |
| |
| Completed |
| 400 |
| September 2009 |
| September 2009 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- patient has stable vascular disease (heart, brain, or blood vessel disease) for 3 months or more
- patient is 18 years of age or older with a history of migraine with or without aura
- Patients must use acceptable contraception throughout the study
Exclusion Criteria:
- patient is pregnant, breast-feeding, or planning to become pregnant during this study
- patient was 50 years of age or older when migraines began
- patient has other pain syndromes that might interfere with study assessments, uncontrolled psychiatric conditions, dementia, or significant neurological disorders (other than migraine)
- patient has a history of gastric, or small intestinal surgery, or has a disease that causes malabsorption
|
| Both |
| 18 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
|
| |
| NCT00662818 |
| Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc. |
| 2007_545, MK0974-034 |
| Merck |
|
| Study Director: |
Medical Monitor |
Merck |
|
|
| Merck |
| September 2009 |
