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An Open Label Extension of a Study of Topiramate in Chronic Migraine.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00210873
First Posted: September 21, 2005
Last Update Posted: June 10, 2011
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:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  Purpose
The purpose of this study is to assess the long-term safety and effectiveness of topiramate for the prevention of headaches in adults with chronic migraine. Topiramate has been approved to prevent migraine headaches.

Condition Intervention Phase
Migraine Drug: topiramate Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: An Open-label Study of the Safety and Efficacy of Topiramate for the Prophylaxis of Chronic Migraine: Extension Study to CAPSS-276

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
  • Patient diaries for number & severity of migraine or migrainous headaches, symptoms, & other medications used; Migraine Disability Assessment, Migraine-Specific Quality of Life, Physicians & Subjects Global Impression of Change for quality of life

Secondary Outcome Measures:
  • Adverse event reports; physical examinations; vital signs; laboratory tests for safety

Enrollment: 200
Study Start Date: February 2004
Study Completion Date: August 2005
Detailed Description:
Migraine headaches can be disabling and can interfere with work and a person's quality of life. Preventing these headaches before they start is the best option. Topiramate, an anti-seizure medication, has been shown to help prevent migraine headaches from occurring. This is an open-label study that is an extension of a previous study (CAPSS-276) of Topiramate in chronic migraine. It includes patients who completed the previous study or who stopped the study early after taking study drug for at least 4 weeks of maintenance treatment due to lack of efficacy. The current study will involve a 4-week Blinded Transition Phase during which patients will be titrated up to a daily topiramate dose of 100 milligrams (or the maximum tolerated dose, whichever is less). Then there will be a 12-week Open-Label Maintenance Phase during which the topiramate dose may be adjusted according to effectiveness and tolerance, but not to exceed a daily dose of 400 milligrams. After this period, patients will be tapered off topiramate (Taper/Exit Phase). The length of the taper/exit phase may vary based on the dose the patient was taking during the open label maintenance phase. While on topiramate, patients will record daily entries in their headache records. Patients will also be asked questions to help assess their quality of life. Both patients and doctors will be asked questions at the end of the study about their impressions of change with respect to the patient's migraine headaches. Patients will also have physical and neurological examinations and laboratory tests performed during the study. The objective of this study is to evaluate the long-term safety and effectiveness of topiramate for the prevention of chronic migraine headaches. Topiramate oral tablets, 25 milligrams per tablet, will be given in the morning and evening to a dose not to exceed 400 milligrams per day or to the maximum tolerated dose, whichever is less
  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of chronic migraine
  • successfully finished double-blind portion of the CAPSS-276 study or discontinued the study after a minimum of 4 weeks maintenance treatment due to lack of effect of study drug
  • in generally good health
  • able to take medicine orally
  • if female, using birth control.

Exclusion Criteria:

  • Cannot have a more painful condition than the headache pain
  • cannot be taking any other medications not allowed by the study protocol
  • no abnormal liver tests
  • not compliant with study medication during the CAPSS-276 study
  • cannot be pregnant or breast-feeding.
  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): NCT00210873


Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Ortho-McNeil Neurologics, Inc.
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00210873     History of Changes
Other Study ID Numbers: CR004672
First Submitted: September 13, 2005
First Posted: September 21, 2005
Last Update Posted: June 10, 2011
Last Verified: May 2010

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Migraine
headache
chronic
prevention

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Topiramate
Anticonvulsants
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Anti-Obesity Agents