- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00210873
An Open Label Extension of a Study of Topiramate in Chronic Migraine.
June 8, 2011 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
An Open-label Study of the Safety and Efficacy of Topiramate for the Prophylaxis of Chronic Migraine: Extension Study to CAPSS-276
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.
Study Overview
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
Study Type
Interventional
Enrollment (Actual)
200
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
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
Outcome Measure |
---|
Adverse event reports; physical examinations; vital signs; laboratory tests for safety
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2004
Study Completion (Actual)
August 1, 2005
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimate)
September 21, 2005
Study Record Updates
Last Update Posted (Estimate)
June 10, 2011
Last Update Submitted That Met QC Criteria
June 8, 2011
Last Verified
May 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR004672
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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