A Double-Blind Placebo-Controlled Trial of Rozerem in Migraine Headaches

• Status: Terminated
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

Summary

To study the effect of Rozerem, a high affinity MT1 and MT2, low affinity 5-HT2B receptor agonist used for insomnia, as a migraine prophylactic agent.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Charlottesville Neuroscience
• Collaborator: Takeda Pharmaceuticals North America, Inc.

Criteria

Inclusion Criteria:

• Age 18-65

• 3-8 Migraine headaches/month

• Able to understand and comply with the study

Exclusion Criteria:

• Currently on migraine prophylaxis

• Currently on sleep medication > 4days/month

• Currently on Fluvoxamine

• Untreated psychiatric or sleep disorders

• MRI abnormalities other than those attributable to migraine headaches

• Abnormalities on neurological exam other than known neurological disorders unassociated with migraine or sleep

• Known disorders of prolactin

• Bipolar disorder

• Hepatic disease

• Pregnancy