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Pilot study of MK-462 in migraine
N R Cutler1, J Claghorn, J J Sramek
1California Clinical Trials, Beverly Hills, USA.
Cephalalgia : an International Journal of Headache
|April 1, 1996
Summary
MK-462, a 5HT1D receptor agonist, shows promise for acute migraine treatment. The 40 mg dose significantly outperformed placebo in relieving headache severity, suggesting its potential for further study.
Area of Science:
- Neuroscience
- Pharmacology
Background:
- Migraine is a debilitating neurological condition.
- Effective acute treatments are needed to manage migraine attacks.
Purpose of the Study:
- To evaluate the preliminary efficacy and safety of oral MK-462 for acute migraine.
- To compare MK-462 doses (20 mg and 40 mg) against a placebo.
Main Methods:
- A double-blind, placebo-controlled inpatient study.
- 65 male and post-menopausal female patients with moderate to severe migraine were enrolled.
- Headache severity and functional disability were assessed at multiple time points post-dose.
Main Results:
- The 40 mg dose of MK-462 was well tolerated and significantly superior to placebo in reducing headache severity at 1.5 and 2 hours (75% relief vs. 33%).
- The 20 mg dose showed some efficacy, with 50% of patients experiencing relief.
- Common adverse events included drowsiness, dry mouth, and lightheadedness, with higher incidence in the 40 mg group.
Conclusions:
- MK-462 demonstrates preliminary efficacy in treating acute migraine.
- The 40 mg dose appears particularly promising and warrants further investigation.
- MK-462 is a potential candidate for continued development as an acute migraine therapy.