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Detoxification and Treatment of Subjects With Medication Overuse Headache

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2007 by The New England Center for Headache, P.C..
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Ortho-McNeil Neurologics, Inc.
Information provided by:
The New England Center for Headache, P.C.
ClinicalTrials.gov Identifier:
NCT00432549
First received: February 6, 2007
Last updated: February 7, 2007
Last verified: February 2007
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Evaluation of Almotriptan and Topiramate in the Detoxification and Treatment of Subjects With Medication Overuse Headache

Resource links provided by NLM:

MedlinePlus related topics: Headache
U.S. FDA Resources

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

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

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

Additional relevant MeSH terms:
Headache Disorders, Secondary
Headache Disorders
Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Diseases
Central Nervous System Diseases
Topiramate
Almotriptan
Anticonvulsants
 Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Anti-Obesity Agents
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 22, 2013