Detoxification and Treatment of Subjects With Medication Overuse Headache

This study is currently recruiting participants.

Verified by The New England Center for Headache, P.C., February 2007

First Received: February 6, 2007 Last Updated: February 7, 2007 History of Changes

Sponsors and Collaborators:	The New England Center for Headache, P.C. Ortho-McNeil Neurologics, Inc.
Information provided by:	The New England Center for Headache, P.C.
ClinicalTrials.gov Identifier:	NCT00432549

Purpose

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.

Condition	Intervention	Phase
Analgesic Rebound Headache	Drug: Almotriptan Drug: Topiramate	Phase IV

MedlinePlus related topics: Headache

Drug Information available for: Topiramate Almotriptan

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Evaluation of Almotriptan and Topiramate in the Detoxification and Treatment of Subjects With Medication Overuse Headache

Further study details as provided by The New England Center for Headache, P.C.:

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

Estimated Enrollment:	60
Study Start Date:	January 2007
Estimated Study Completion Date:	February 2007

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00432549

Contacts

Contact: Alfredo DaSilva	203-322-2748	adasilva@nech.net
Contact: Jo-Ann Epstein	203-322-2748	jepstein@nech.net

Locations

United States, Connecticut
The New England Center for Headache, P.C.	Recruiting
Stamford, Connecticut, United States, 06902
Principal Investigator: Fred D Sheftell, M.D.

Sponsors and Collaborators

The New England Center for Headache, P.C.

Ortho-McNeil Neurologics, Inc.

Investigators

Principal Investigator:

Fred D Sheftell, M.D.

The New England Center for Headache, P.C.

More Information

No publications provided

Study ID Numbers:	CAPSS-328
Study First Received:	February 6, 2007
Last Updated:	February 7, 2007
ClinicalTrials.gov Identifier:	NCT00432549 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by The New England Center for Headache, P.C.:

Medication overuse

Study placed in the following topic categories:

Serotonin Agonists
Neurotransmitter Agents
Almotriptan
Central Nervous System Diseases
Pain
Brain Diseases
Neuroprotective Agents
Serotonin
Headache Disorders

Anti-Obesity Agents
Signs and Symptoms
Headache Disorders, Secondary
Headache
Neoplasm Metastasis
Neurologic Manifestations
Topiramate
Anticonvulsants

Additional relevant MeSH terms:

Serotonin Agonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Almotriptan
Physiological Effects of Drugs
Nervous System Diseases
Central Nervous System Diseases
Pain
Brain Diseases
Protective Agents
Neuroprotective Agents
Pharmacologic Actions

Headache Disorders
Anti-Obesity Agents
Signs and Symptoms
Serotonin Agents
Headache Disorders, Secondary
Therapeutic Uses
Headache
Neurologic Manifestations
Topiramate
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on May 06, 2009