CompletedPhase 4

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

385 participantsStarted 2005-09

Plain-language summary

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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The primary efficacy parameter will be whether or not a patient experiences 15 or more headache days (migraine and non-migraine) during the last 28 days of the study.

Trial details

NCT IDNCT00212810

SponsorOrtho-McNeil Neurologics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

View on ClinicalTrials.gov More Migraine trials

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.