A Double-Blind, Placebo-Controlled Study Examining the Use of Topiramate in the Treatment of Cluster Headache
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
Topiramate is a medication that has been approved by the Food and Drug Administration (FDA) for the treatment of patients with seizures. The trade name for this drug is Topamax®. Topiramate has not been approved by the FDA for the treatment of cluster headache and is experimental for the purposes of this research study. If a subject participates in this study, he/she will increase his/her dose of topiramate rapidly in the first few weeks to try to stop the cluster attacks and then will continue on a maintenance dose of topiramate in order to determine if it can prevent attacks from occurring during that cluster period. We believe that this will lead not only to a faster but a more complete remission of the cluster period.
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, Learn About Clinical Studies.
Layout table for eligibility information
Ages Eligible for Study:
18 Years to 65 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Subjects between the ages of 18 and 65 with a diagnosis of cluster headache (episodic or chronic) as defined by the International Classification of Headache Disorders (2nd edition)
Subjects must have a lifetime prevalence of at least 2 prior cluster cycles.
Subjects must experience one or more attacks/ day during baseline period
Subjects must have a typical cluster period lasting at least 8 weeks. Subjects must present in active cluster period and the expected remaining duration of the cluster cycle must be at least 8 weeks from Baseline visit.
Subjects with other headache types are eligible provided the subject is able to differentiate these headaches from cluster headaches.
Subject is using or agrees to use for the duration of participation a medically acceptable form of contraception (as determined by investigator), if female of child-bearing potential
Subject has negative urine pregnancy test prior to study entry, if female of child-bearing potential
Subject is able to understand and comply with all study requirements
Subject provides written informed consent prior to any screening procedures being conducted
Women who are pregnant or lactating
Subjects who, in the investigators opinion, have a history or have evidence of a medical or psychiatric condition that would expose them to an increased risk of a significant adverse event or would interfere with the assessments of efficacy and tolerability during this trial
Subjects who require a change in medication or existing regimen of medication for the prophylaxis of cluster in the 4 weeks prior to Baseline visit and for the duration of the trial
Subjects who have cluster headaches that typically exceed 4 hours
Subjects who have used the following medications/ treatments from four weeks prior to Baseline visit: corticosteroids and nerve blocks.
Subjects using any drug which might interact adversely with, or interfere with the action of, the study medication (e.g., carbonic anhydrase inhibitors)
Subjects who have failed an adequate trial of topiramate for cluster headaches due to lack of efficacy or adverse events, as determined by the investigator
Subjects with a history of nephrolithiasis.
Subjects who are allergic to or have shown hypersensitivity topiramate or agents similar to topiramate
Subjects who abuse opioids as determined by investigator
Subjects with a history of significant drug or alcohol abuse within the past year
Subjects who have participated in an investigational drug trial in the 30 days prior to the screening visit