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An Open Label Extension of a Study Comparing Topiramate and Amitriptyline in Migraine Prevention.

This study has been completed.

Sponsors and Collaborators: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Ortho-McNeil Neurologics, Inc.
Information provided by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00210860
  Purpose

The purpose of this study is to assess the long-term safety and effectiveness of topiramate for the prevention of migraine headaches in adults. Topiramate has been approved to prevent migraine headaches in adults.


Condition Intervention Phase
Migraine
Drug: topiramate
Phase III

Genetics Home Reference related topics:   familial hemiplegic migraine   

MedlinePlus related topics:   Headache    Migraine   

ChemIDplus related topics:   Topiramate    Amitriptyline    Amitriptyline hydrochloride   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:   An Open-Label Study of the Safety and Efficacy of Topiramate for Migraine Prophylaxis: Extension Study to CAPSS-277

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

Primary Outcome Measures:
  • Patient diary: number, duration, severity of headaches, symptoms, other medications used; QOL: Migraine Disability Assessment, Migraine-Specific Quality of Life, Quality of Life Enjoyment & Satisfaction Questionnaire-Short Form, Weight Satisfaction Scale

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

Estimated Enrollment:   330
Study Start Date:   September 2004
Study Completion Date:   March 2006

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-277) comparing topiramate and amitriptyline in migraine prevention. It includes patients who completed the previous study and elected to enter open label treatment with topiramate. The 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. While on topiramate, patients will record daily entries in their headache records. Patients will be asked questions to help assess their quality of life. Patients will also have physical 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 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
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Diagnosis of migraine with or without aura
  • Successfully finished CAPSS-277 study
  • In generally good health
  • Able to take medicine orally
  • If female, using birth control

Exclusion Criteria:

  • Not having a more painful condition than the headache pain
  • Cannot be taking any other medications not allowed by the study
  • Abnormal liver tests
  • Not compliant with study medication during the CAPSS-277 study
  • Pregnant or breast-feeding
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00210860

Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Ortho-McNeil Neurologics, Inc.

Investigators
Study Director:     Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial     Johnson & Johnson Pharmaceutical Research & Development, L.L.C.    
  More Information


An Open-Label Study of the Safety and Efficacy of Topiramate for Migraine Prophylaxis: Extension Study to CAPSS-277  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CR004669
First Received:   September 13, 2005
Last Updated:   March 24, 2008
ClinicalTrials.gov Identifier:   NCT00210860
Health Authority:   United States: Food and Drug Administration

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

Study placed in the following topic categories:
Migraine Disorders
Headache
Amitriptyline
Topiramate
Central Nervous System Diseases
Headache Disorders, Primary
Brain Diseases
Headache Disorders

Additional relevant MeSH terms:
Anti-Obesity Agents
Therapeutic Uses
Physiological Effects of Drugs
Nervous System Diseases
Central Nervous System Agents
Protective Agents
Neuroprotective Agents
Anticonvulsants
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 03, 2008




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