Status:
TERMINATED
A Double-Blind Placebo-Controlled Trial of Rozerem in Migraine Headaches
Lead Sponsor:
Charlottesville Neuroscience
Collaborating Sponsors:
Takeda Pharmaceuticals North America, Inc.
Conditions:
Migraine Headache
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief 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.
Detailed Description
In a recent, large study of migraineurs, over half reported difficulties with sleep initiation or maintenance. Those who had shorter average sleep times reported more severe headaches. Poor sleep has ...
Eligibility Criteria
Inclusion
- Age 18-65
- 3-8 Migraine headaches/month
- Able to understand and comply with the study
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT00391755
Start Date
October 1 2006
End Date
October 1 2009
Last Update
February 10 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Patricia Shipley, MD
Charlottesville, Virginia, United States, 22902