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

This study has been completed.

Sponsor:

Collaborator:

Ortho-McNeil Neurologics, Inc.

Information provided by:

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

ClinicalTrials.gov Identifier:

NCT00210873

First received: September 13, 2005

Last updated: June 8, 2011

Last verified: May 2010

History of Changes

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: 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:

MedlinePlus related topics: Headache Migraine

Drug Information available for: Topiramate

U.S. FDA Resources

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


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

An open label extension of a study of Topiramate in chronic migraine. This link exits the ClinicalTrials.gov site


ClinicalTrials.gov Identifier:	NCT00210873 History of Changes
Other Study ID Numbers:	CR004672
Study First Received:	September 13, 2005
Last Updated:	June 8, 2011

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

ClinicalTrials.gov processed this record on July 18, 2017

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