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Detoxification and Treatment of Subjects With Medication Overuse Headache

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ClinicalTrials.gov Identifier: NCT00432549
Recruitment Status : Unknown
Verified February 2007 by The New England Center for Headache, P.C..
Recruitment status was:  Recruiting
First Posted : February 8, 2007
Last Update Posted : February 8, 2007
Sponsor:
Collaborator:
Ortho-McNeil Neurologics, Inc.
Information provided by:
The New England Center for Headache, P.C.

February 6, 2007
February 8, 2007
February 8, 2007
January 2007
Not Provided
  • 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
Same as current
No Changes Posted
  • 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
  • Headache frequency through day ninety
Same as current
Not Provided
Not Provided
 
Detoxification and Treatment of Subjects With Medication Overuse Headache
Evaluation of Almotriptan and Topiramate in the Detoxification and Treatment of Subjects With Medication Overuse Headache
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Analgesic Rebound Headache
  • Drug: Almotriptan
  • Drug: Topiramate
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
60
Same as current
February 2007
Not Provided

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00432549
CAPSS-328
Not Provided
Not Provided
Not Provided
Not Provided
The New England Center for Headache, P.C.
Ortho-McNeil Neurologics, Inc.
Principal Investigator: Fred D Sheftell, M.D. The New England Center for Headache, P.C.
The New England Center for Headache, P.C.
February 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP