Detoxification and Treatment of Subjects With Medication Overuse Headache
Phase 4
- Conditions
- Analgesic Rebound Headache
- Registration Number
- NCT00432549
- Lead Sponsor
- The New England Center for Headache, P.C.
- Brief Summary
The purpose of this study is to assess the benefits of almotriptan used as a transitional therapy and topiramate in subjects with medication overuse headaches (MOH.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
- Medication overuse headaches 18 years of age and older Must have a diagnosis of probable medication overuse headache Must have greater than fifteen headache days per month Must be in generally good health Female subjects must be postmenopausal or practicing an acceptable method of birth control
Exclusion Criteria
- Not overusing six or more tablets per day of compounds containing barbituates opioids No overuse of triptans Previous failure or side effects with topiramate or almotriptan Cannot be pregnant or lactating
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Primary measure for the detoxification period Number of days with mild or no pain in the first two weeks of treatment Primary for the prevention of relapse Pain free days through day ninety
- Secondary Outcome Measures
Name Time Method Headache frequency through day ninety Primary measure for the detoxification period Number of days without any headache in the first two weeks of treatment Primary for the prevention of relapse
Trial Locations
- Locations (1)
The New England Center for Headache, P.C.
🇺🇸Stamford, Connecticut, United States