Detoxification and Treatment of Subjects With Medication Overuse Headache

Analgesic Rebound Headache Clinical Trial

Official title:

Evaluation of Almotriptan and Topiramate in the Detoxification and Treatment of Subjects With Medication Overuse Headache

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00432549
• Other study ID #: CAPSS-328
• Status: Recruiting
• Phase: Phase 4
• First received: February 6, 2007
• Last updated: February 7, 2007
• Start date: January 2007
• Est. completion date: February 2007

Study information

• Verified date: February 2007
• Source: The New England Center for Headache, P.C.
• Contact: Alfredo DaSilva
• Phone: 203-322-2748
• Email: adasilva[@]nech.net
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Analgesic Rebound Headache
• Headache
• Headache Disorders, Secondary

Intervention

Drug:
• Almotriptan

• Topiramate

Locations

Country	Name	City	State
United States	The New England Center for Headache, P.C.	Stamford	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
The New England Center for Headache, P.C.	Ortho-McNeil Neurologics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary measure for the detoxification period
Primary	Number of days with mild or no pain in the first two weeks of treatment
Primary	Primary for the prevention of relapse
Primary	Pain free days through day ninety
Secondary	Primary measure for the detoxification period
Secondary	Number of days without any headache in the first two weeks of treatment
Secondary	Primary for the prevention of relapse
Secondary	Headache frequency through day ninety