A Double-Blind, Placebo-Controlled Study Examining the Use of Topiramate in the Treatment of Cluster Headache - Full Text View

Sponsor:	Thomas Jefferson University
Collaborator:	Ortho-McNeil Neurologics, Inc.
Information provided by:	Thomas Jefferson University
ClinicalTrials.gov Identifier:	NCT00203190

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 IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Control: Placebo Control 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.

Resource links provided by NLM:

MedlinePlus related topics: Headache

Drug Information available for: Topiramate

U.S. FDA Resources

Further study details as provided by Thomas Jefferson University:

Primary Outcome Measures:

Change in the average daily frequency of moderate or severe attacks between baseline period to the period of day 14 to 56.

Secondary Outcome Measures:

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00203190

Locations

United States, Pennsylvania
Jefferson Headache Center
Philadelphia, Pennsylvania, United States, 19107

Sponsors and Collaborators

Thomas Jefferson University

Ortho-McNeil Neurologics, Inc.

Investigators

Principal Investigator:

William B Young, MD

Thomas Jefferson University, Jefferson Headache Center

More Information

No publications provided

Study ID Numbers:	SDS/TOP-CL/01/CAPSS-322, 080-19000-H56501
Study First Received:	September 12, 2005
Last Updated:	January 22, 2009
ClinicalTrials.gov Identifier:	NCT00203190 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Cluster Headache
Physiological Effects of Drugs
Nervous System Diseases
Central Nervous System Diseases
Headache Disorders, Primary
Pain
Brain Diseases
Protective Agents
Neuroprotective Agents
Pharmacologic Actions

Headache Disorders
Anti-Obesity Agents
Signs and Symptoms
Trigeminal Autonomic Cephalalgias
Therapeutic Uses
Headache
Neurologic Manifestations
Topiramate
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on March 18, 2010