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Detoxification and Treatment of Subjects With Medication Overuse Headache

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2007 by The New England Center for Headache, P.C..
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00432549
First Posted: February 8, 2007
Last Update Posted: February 8, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Ortho-McNeil Neurologics, Inc.
Information provided by:
The New England Center for Headache, P.C.
  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
Intervention Model: Parallel Assignment
Masking: Double
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:


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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00432549     History of Changes
Other Study ID Numbers: CAPSS-328
First Submitted: February 6, 2007
First Posted: February 8, 2007
Last Update Posted: February 8, 2007
Last Verified: February 2007

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

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


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