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

Stopped early · Phase 4 · Has a placebo group

Conditions studied: Migraine Headache

In brief

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.

Key facts

Study ID

NCT00391755

Run by

Charlottesville Neuroscience

People needed

4

Starts

2006-10-01

Expected to finish

2009-10-01

Last updated by the study team

2012-02-10

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age 18-65
• 3-8 Migraine headaches/month
• Able to understand and comply with the study

You may not qualify if…

• 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

Where it is running

• Patricia Shipley, MD — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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