NCT00739024

A Study of a Melatonin Receptor Agonist to Prevent Migraine

A Randomized, Double-blind Placebo-controlled, Parallel Group Study to Study the Efficacy and Tolerability of Ramelteon (Rozerem) in the Prophylaxis of Migraine

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Swedish Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to see if ramelteon will reduce the number of migraine headaches over a 12 week period. The safety and tolerability of ramelteon will also be evaluated. Ramelteon has been approved by the U.S. Food and Drug Administration (FDA) for insomnia (trouble sleeping); however; ramelteon has not been approved for the prevention of migraines.

Detailed description

Sleep has played an important role in migraine. Younger migraine sufferers usually report relief of migraine after sleep. In older migraine sufferers migraine is sometimes triggered with sleep changes. Occurrence of migraine in the early morning is very common. Therefore in these individuals regulation of sleep may improve the frequency of migraine. Recent PET studies done during migraine demonstrated activation of hypothalamus during migraine. In light of this new data and the known action of ramelteon on the melatonin receptors it may theoretically provide an insight on a possible mechanism of action in migraine.

Conditions

• Migraine
• Migraine With Aura
• Migraine Without Aura

Interventions

Type	Name	Description
DRUG	Ramelteon	8 mg tablet, oral, once daily
DRUG	Placebo	Placebo tablet, oral, once daily

Timeline

• Start date: 2008-04-01
• Primary completion: 2009-04-01
• Completion: 2010-09-01
• First posted: 2008-08-21
• Last updated: 2012-08-23
• Results posted: 2012-08-23

Locations

1 site across 1 country: United States