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

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

April 23, 2009

Start Date ^ICMJE

September 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00210860 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Adverse event reports; physical examinations; vital signs; electrocardiogram; laboratory tests for safety

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

An Open-Label Study of the Safety and Efficacy of Topiramate for Migraine Prophylaxis: Extension Study to CAPSS-277

Brief 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.

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

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Migraine

Intervention ^ICMJE

Drug: topiramate

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

142

Completion Date

March 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00210860

Responsible Party

Study ID Numbers ^ICMJE

CR004669

Study Sponsor ^ICMJE

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Collaborators ^ICMJE

Ortho-McNeil Neurologics, Inc.

Investigators ^ICMJE

Study Director:

Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Information Provided By

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Verification Date

April 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP