Detoxification and Treatment of Subjects With Medication Overuse Headache

NCT ID: NCT00432549

Last Updated: 2007-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2007-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Analgesic Rebound Headache

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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Almotriptan

Intervention Type DRUG

Topiramate

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ortho-McNeil Neurologics, Inc.

INDUSTRY

Sponsor Role collaborator

The New England Center for Headache, P.C.

OTHER

Sponsor Role lead

Principal Investigators

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Fred D Sheftell, M.D.

Role: PRINCIPAL_INVESTIGATOR

The New England Center for Headache, P.C.

Locations

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The New England Center for Headache, P.C.

Stamford, Connecticut, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Alfredo DaSilva

Role: CONTACT

203-322-2748

Jo-Ann Epstein

Role: CONTACT

203-322-2748

Other Identifiers

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CAPSS-328

Identifier Type: -

Identifier Source: org_study_id

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