Recruiting

Detoxification with Medication

Sponsor:

The New England Center for Headache, P.C.

Code:

NCT00432549

Conditions

Analgesic Rebound Headache

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Almotriptan

Topiramate

Study Details

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.

Conditions

Analgesic Rebound Headache

Study ID

NCT00432549

Start date

Jan, 2007

Status verified date

Feb, 2007

Completion date

Feb, 2007

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

60 participants

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Interventions

Almotriptan

Topiramate

Primary outcome measure

  • Primary measure for the detoxification period [ Time Frame: undefined ]
  • Number of days with mild or no pain in the first two weeks of treatment [ Time Frame: undefined ]
  • Primary for the prevention of relapse [ Time Frame: undefined ]
  • Pain free days through day ninety [ Time Frame: undefined ]

Central Contacts and Locations

Central contacts

Alfredo DaSilva

203-322-2748adasilva@nech.net

Jo-Ann Epstein

203-322-2748jepstein@nech.net

Locations

The New England Center for Headache, P.C.

Recruiting

Stamford, Connecticut, United States, 06902

Principal Investigator:

Fred D Sheftell, M.D.

More Information

Sponsor

The New England Center for Headache, P.C.

Last update posted

Feb 8, 2007

Last verified

Feb, 2007

Keywords

  • Medication overuse

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The New England Center for Headache, P.C. on 2007-02-08.