A Double-Blind, Placebo-Controlled Study Examining the Use of Topiramate in the Treatment of Cluster Headache
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cluster Headache |
Drug: Topiramate |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Single-Center, Randomized, Double-Blind, Placebo Controlled Trial Examining the Safety and Efficacy of Topiramate in the Treatment of Subjects With Episodic or Chronic Cluster Headache. |
- Change in the average daily frequency of moderate or severe attacks between baseline period to the period of day 14 to 56.
- Change in the average daily frequency of any attacks from the baseline period through the entire treatment period.
- Change in the average daily duration of any attacks from the baseline period through the entire treatment period.
- Change in the average daily attack severity from baseline period through the entire treatment period.
- Change in the average daily frequency of any attacks from the baseline period to each week during the treatment period.
- Change in the average daily duration of any attacks from the baseline period to each week during the treatment period.
- Change in the average daily attack severity from the baseline period to each week during the treatment period.
- Time to the first week from the baseline period with a 50% reduction in average daily frequency of moderate or severe attacks.
- Change in use of acute and rescue medications from the baseline period through the entire treatment period.
| Estimated Enrollment: | 60 |
| Study Start Date: | September 2004 |
| Estimated Study Completion Date: | June 2006 |
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Pennsylvania | |
| Jefferson Headache Center | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Principal Investigator: | William B Young, MD | Thomas Jefferson University, Jefferson Headache Center |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00203190 History of Changes |
| Other Study ID Numbers: | SDS/TOP-CL/01/CAPSS-322, 080-19000-H56501 |
| Study First Received: | September 12, 2005 |
| Last Updated: | January 22, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Cluster Headache Headache Trigeminal Autonomic Cephalalgias Headache Disorders, Primary Headache Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Pain Neurologic Manifestations |
Signs and Symptoms Topiramate Anticonvulsants Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Neuroprotective Agents Protective Agents Physiological Effects of Drugs Anti-Obesity Agents |
ClinicalTrials.gov processed this record on May 21, 2013