Evaluation of the Effectiveness of Topiramate in Preventing the Transformation From Episodic Migraine to Chronic Daily Headache.

Ortho-McNeil

Status and phase

Completed

Phase 4

Conditions

Common Migraine

Migraine

Classic Migraine

Headache

Treatments

Drug: Topiramate

Study type

Interventional

Funder types

Industry

Identifiers

NCT00212810

CR002854

Details and patient eligibility

About

The purpose of this study is to determine whether Topiramate is effective in preventing the development of chronic daily headache among patients with episodic migraine headaches.

Full description

Chronic daily headache encompasses a frequent headache state in which the increased burden of pain further compromises quality of life and adversely impacts patients, their families, and health care providers. Approximately 5% of patients with migraine, or an estimated 1.4 million Americans, manifest a chronic daily headache form of disease. The consequences include resistance to treatment, worsening quality of life, increased use and over use of medication, and development of ischemic and other neuropathological brain lesions. This is a randomized, double-blind, placebo-controlled multicenter study that will enroll patients 18-65 years old with an established history of migraine headaches who, in the 28 days prior to the study should have a migraine frequency of at least 10 but less than 15 migraine headache days per month, and less than 15 total headache days (migraine plus non migraine headaches) per month. The study duration will be approximately 26 weeks. The study is divided into 4 phases as follows: A Screening/Washout Phase that may last between 2-6 weeks, depending on whether you need to stop taking a medication that is not allowed in the study; A Baseline Phase lasting 4 weeks, at which time information will be collected on the migraine and non-migraine headaches you experience during this period; A double-blind Titration Phase lasting 4-6 weeks where all patients will be randomized to treatment with either Topiramate or placebo. If you are randomized to Topiramate, your dose will be gradually increased up to a dose of either 75 or 100 mg a day; A Maintenance Period lasting 20 weeks at which time you will continue on the dose you were taking at the completion of the Titration period; and a Taper/Exit phase, lasting 2 weeks, where you will gradually reduce the dose of study medication you were taking during the study. The study hypothesis is that the study drug will be more effective than placebo in preventing patients from transforming from episodic migraines to chronic daily headaches. Each patient will be asked to record their headache pain information and medication use on paper headache diaries. Patients will receive either Topiramate or placebo. The number of tablets of topiramate or placebo, will be gradually increased to either a minimum of 3 tablets/day or a maximum of 4 tablets/day. For those on Topiramate, 3 tablets would represent 75 mg and 4 tablets would represent 100 mg/day.

Enrollment

385 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

To qualify for this study you must be 18-65 years old
have a history of migraine headaches for at least 1 year
experience at least 10 but less than 15 migraine headache days and less than 15 total headache days/month
able to take oral medication
able to understand and sign the informed consent and to complete headache diaries.

Exclusion criteria

You will not be able to participate in the study if you previously discontinued Topiramate because it did not make you feel better or it made you feel different
have migraine aura without headache
have a positive urine drug screen
have a history of kidney stones
have a history of suicide attempt
pregnant females
already on a migraine preventive medicine.