An Open Label Extension of a Study Comparing Topiramate and Amitriptyline in Migraine Prevention.
Information source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Migraine
Intervention: topiramate (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Official(s) and/or principal investigator(s): Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial, Study Director, Affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Summary
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.
Clinical Details
Official title: An Open-label Study of the Safety and Efficacy of Topiramate for Migraine Prophylaxis: Extension Study to CAPSS-277
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: 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: Adverse event reports; physical examinations; vital signs; electrocardiogram; laboratory tests for safety
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Additional Information
An Open-Label Study of the Safety and Efficacy of Topiramate for Migraine Prophylaxis: Extension Study to CAPSS-277
Starting date: September 2004
Last updated: June 8, 2011
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