A Study to Measure the Safety and Effectiveness of Zonisamide in Subjects With Migraine Headache
A Double-Blind, Randomized, Multicenter, Parallel Dose Study to Evaluate the Safety and Efficacy of Zonisamide 150 mg and 300 mg Per Day and Placebo in Subjects With Migraine Headache
1 other identifier
interventional
204
1 country
13
Brief Summary
The purpose of this study is to determine if zonisamide is effective as a preventative medication for individuals with migraine headache.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2002
Shorter than P25 for phase_2
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2002
CompletedFirst Submitted
Initial submission to the registry
March 3, 2003
CompletedFirst Posted
Study publicly available on registry
March 5, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2003
CompletedDecember 14, 2015
December 1, 2015
March 3, 2003
December 10, 2015
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Subjects who meet all the following criteria will be eligible to participate in the study:
- Are men or women, between the ages of 18 and 65, inclusive.
- Satisfy diagnostic criteria for migraine headache, consistent with criteria described in Headache Classification Criteria.
- Have at least 4 migraine attacks per 28 days \[each attack separated by at least 48 hours\] prior to the Screening Visit and experience at least 4 migraine attacks during the Screen/Baseline Phase.
- Agree to not become pregnant during the study and agree to use an adequate method of birth control during the study such as an adequate barrier method, hormonal contraceptive, or surgical sterilization. All women of childbearing potential must have a negative pregnancy test before entering the study and during the study.
- Are able to swallow the capsules whole.
- Are willing and able to follow Investigator instructions and study procedures, complete the daily diary, and report adverse events.
You may not qualify if:
- Subjects meeting any of the following criteria will not be eligible to participate in this study:
- Have required more than 3 different rescue medications for control of a single attack anytime within 3 months prior to the Screening Visit.
- Have cluster headache or chronic tension type headache and are unable to distinguish between their different types of headache.
- Have basilar or hemiplegic migraine.
- Have used triptans more than 3 times per week within 3 months prior to the Screening Visit.
- Have received botulinum toxin injection(s) within 3 months prior to the Screening Visit.
- Have taken any other prophylactic medications for migraine within 5 half-lives prior to the Baseline Visit.
- Are pregnant or lactating.
- Have a history or current diagnosis of psychiatric disorder likely to require pharmacological intervention (e.g., antidepressants, MAO inhibitors, antipsychotics, mood-stabilizers, anxiolytics) during the study.
- Have clinically unstable cardiovascular, hepatic, renal, gastrointestinal, pulmonary, metabolic, endocrine or other systemic disease.
- Have laboratory test results that, in the opinion of the Investigator, are clinically significant abnormalities.
- Require treatment with any medication (e.g., daily opioids, daily beta-blockers, daily non-steroidal anti-inflammatory drugs, carbonic anhydrase inhibitors, eletriptan) or herbal supplements (e.g., St. John's Wort, ginseng, ginkgo biloba, kava kava, melatonin, petadolex) that might interact adversely with, or obscure, the action of the study medication.
- Have received psychoactive medication (e.g., other anticonvulsant drugs, antidepressants, antipsychotics, anxiolytics, mood stabilizers) within 5 half-lives prior to the Baseline Visit.
- Have previously enrolled in this study or previously treated with zonisamide.
- Have previously failed an adequate trial of another antiepilepsy drug for the treatment of migraine.
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Medical Affiliated Research Center
Huntsville, Alabama, 35801, United States
University of South Alabama Medical Ctr Department of Neurology
Mobile, Alabama, 36693, United States
Valley Neurological Headache Clinic
Phoenix, Arizona, 85020, United States
The New England Center for Headache
Stamford, Connecticut, 06902, United States
Radiant Research
Overland Park, Kansas, 66215, United States
Michigan Head-Pain & Neurological Institute
Ann Arbor, Michigan, 48104, United States
Mercy Health Research
Chesterfield, Missouri, 63017, United States
Headache Care Center
Springfield, Missouri, 65804, United States
Neurological Associates of Tulsa
Tulsa, Oklahoma, 74136, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
MetaClin Research
Austin, Texas, 19107, United States
Houston Headache Clinic
Houston, Texas, 77004, United States
Radiant Research
Salt Lake City, Utah, 84111, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 3, 2003
First Posted
March 5, 2003
Study Start
March 1, 2002
Study Completion
May 1, 2003
Last Updated
December 14, 2015
Record last verified: 2015-12