a double-blind, placebo-controlled study examining the use of topiramate in the treatment of cluster headache

Conditions: Cluster Headache

Summary: 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.


Eligibility criteria:
inclusion criteria: * 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 exclusion criteria: * 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