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Montelukast for migraine prophylaxis: a randomized, double-blind, placebo-controlled study
Jan L Brandes1, W Hester Visser, Mildred V Farmer
1Nashville Neuroscience Group, Nashville, TN, USA.
Headache
|June 10, 2004
Summary
Montelukast 20 mg did not prove effective for migraine prevention in a randomized trial. The drug was well-tolerated by patients but did not significantly reduce migraine frequency compared to placebo.
Area of Science:
- Neurology
- Pharmacology
Background:
- Montelukast, a cysteinyl leukotriene receptor antagonist used for asthma, was previously suggested to have prophylactic effects in migraine.
- A small open-label study indicated potential efficacy, prompting further investigation.
Purpose of the Study:
- To assess the efficacy and tolerability of montelukast 20 mg as a prophylactic treatment for migraine.
- To confirm findings from a prior open-label study in a randomized controlled trial setting.
Main Methods:
- A multicenter, randomized, double-blind, placebo-controlled study involving adult migraine outpatients.
- Patients experienced 3-8 migraine attacks per month and underwent a 2-month placebo run-in, followed by a 3-month double-blind treatment phase.
- The primary endpoint was the proportion of patients achieving at least a 50% reduction in monthly migraine frequency.
Main Results:
- No significant difference in the percentage of patients achieving 50% migraine reduction between montelukast (15.4%) and placebo (10.3%) groups (P=.304).
- Montelukast 20 mg did not show superiority over placebo for any secondary efficacy endpoints.
- Adverse event rates were comparable between the montelukast and placebo groups.
Conclusions:
- Montelukast 20 mg is well-tolerated in patients suffering from migraine.
- The study concluded that montelukast 20 mg is not an effective prophylactic agent for migraine prevention.