Back to resultsDetoxification and Treatment of Subjects With Medication Overuse Headache
Primary Purpose
Analgesic Rebound Headache
Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Almotriptan
Topiramate
Sponsored by
About this trial
This is an interventional prevention trial for Analgesic Rebound Headache focused on measuring Medication overuse
Eligibility Criteria
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
Sites / Locations
- The New England Center for Headache, P.C.Recruiting
Outcomes
Primary Outcome Measures
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
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
Full Information
NCT ID
NCT00432549
First Posted
February 6, 2007
Last Updated
February 7, 2007
Sponsor
The New England Center for Headache, P.C.
Collaborators
Ortho-McNeil Neurologics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00432549
Brief Title
Detoxification and Treatment of Subjects With Medication Overuse Headache
Official Title
Evaluation of Almotriptan and Topiramate in the Detoxification and Treatment of Subjects With Medication Overuse Headache
Study Type
Interventional
2. Study Status
Record Verification Date
February 2007
Overall Recruitment Status
Unknown status
Study Start Date
January 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2007 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
The New England Center for Headache, P.C.
Collaborators
Ortho-McNeil Neurologics, Inc.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Analgesic Rebound Headache
Keywords
Medication overuse
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
60 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Almotriptan
Intervention Type
Drug
Intervention Name(s)
Topiramate
Primary Outcome Measure Information:
Title
Primary measure for the detoxification period
Title
Number of days with mild or no pain in the first two weeks of treatment
Title
Primary for the prevention of relapse
Title
Pain free days through day ninety
Secondary Outcome Measure Information:
Title
Primary measure for the detoxification period
Title
Number of days without any headache in the first two weeks of treatment
Title
Primary for the prevention of relapse
Title
Headache frequency through day ninety
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alfredo DaSilva
Phone
203-322-2748
Email
adasilva@nech.net
First Name & Middle Initial & Last Name or Official Title & Degree
Jo-Ann Epstein
Phone
203-322-2748
Email
jepstein@nech.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fred D Sheftell, M.D.
Organizational Affiliation
The New England Center for Headache, P.C.
Official's Role
Principal Investigator
Facility Information:
Facility Name
The New England Center for Headache, P.C.
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06902
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fred D Sheftell, M.D.
12. IPD Sharing Statement
Learn more about this trial
Detoxification and Treatment of Subjects With Medication Overuse Headache
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