Analgesic Rebound Headache
Conditions
Keywords
Medication overuse
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.
Interventions
DRUGAlmotriptan
DRUGTopiramate
Sponsors
Ortho-McNeil Neurologics, Inc.
The New England Center for Headache, P.C.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain free days through day ninety | — |
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United States
Contacts
Primary ContactAlfredo DaSilva
Backup ContactJo-Ann Epstein
Outcome results
None listed