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A Study to Measure the Safety and Effectiveness of Zonisamide in Subjects With Migraine Headache

This study has been completed.
Sponsor:
Information provided by:
Elan Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00055484
First received: March 3, 2003
Last updated: March 6, 2012
Last verified: March 2012
  Purpose

The purpose of this study is to determine if zonisamide is effective as a preventative medication for individuals with migraine headache.


Condition Intervention Phase
Migraine Headache
Drug: zonisamide
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Elan Pharmaceuticals:

Estimated Enrollment: 204
Study Start Date: March 2002
Study Completion Date: May 2003
Detailed Description:

The pharmacologic treatment of migraine may be acute (abortive, symptomatic) or preventive (prophylactic). Preventive medication is usually given daily for months or years; however, treatment may also be given in an intermittent regimen. Most migraine prophylactic medications were designed to treat other disorders, and they can be divided into three groups:

  1. Serotonergic or monoaminergic agents such as methysergide, which have demonstrated high degrees of effectiveness;
  2. Non-serotonergic drugs such as beta-blockers, tricyclic antidepressants, valproate; and
  3. Drugs with lesser demonstrated effectiveness, such as selective serotonin reuptake inhibitors, calcium channel antagonists, and non-steroidal anti-inflammatory drugs.

The choice of treatment must be individualized, and is influenced by contraindications, potential side effects, the need to treat associated symptoms like tension-type headache and insomnia, and drug cost.

Anticonvulsants, such as valproate, have shown significant degrees of efficacy in migraine prophylaxis when used in low doses. Considering the differences in proposed mechanisms of action of these agents, it is likely that a novel anticonvulsant such as zonisamide may also be an effective prophylactic treatment for migraine.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

INCLUSION:

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.

EXCLUSION:

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.
  • Have a history of allergy or hypersensitivity to zonisamide or other sulfonamides.
  • Have a history of skin rash, without other diagnosis, associated with any medication or any medical condition.
  • Have a history of nephrolithiasis.
  • Have received an experimental drug or used an experimental device within 30 days of the Screening Visit.
  • Have a history of drug or alcohol abuse within 12 months prior to the Screening Visit.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00055484

Locations
United States, Alabama
Medical Affiliated Research Center
Huntsville, Alabama, United States, 35801
University of South Alabama Medical Ctr Department of Neurology
Mobile, Alabama, United States, 36693
United States, Arizona
Valley Neurological Headache Clinic
Phoenix, Arizona, United States, 85020
United States, Connecticut
The New England Center for Headache
Stamford, Connecticut, United States, 06902
United States, Kansas
Radiant Research
Overland Park, Kansas, United States, 66215
United States, Michigan
Michigan Head-Pain & Neurological Institute
Ann Arbor, Michigan, United States, 48104
United States, Missouri
Mercy Health Research
Chesterfield, Missouri, United States, 63017
Headache Care Center
Springfield, Missouri, United States, 65804
United States, Oklahoma
Neurological Associates of Tulsa
Tulsa, Oklahoma, United States, 74136
United States, Pennsylvania
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
MetaClin Research
Austin, Texas, United States, 19107
Houston Headache Clinic
Houston, Texas, United States, 77004
United States, Utah
Radiant Research
Salt Lake City, Utah, United States, 84111
Sponsors and Collaborators
Elan Pharmaceuticals
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00055484     History of Changes
Other Study ID Numbers: AN46046-228
Study First Received: March 3, 2003
Last Updated: March 6, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Elan Pharmaceuticals:
Migraine Headache
prophylaxis
AED
migraine prophylaxis

Additional relevant MeSH terms:
Headache
Migraine Disorders
Brain Diseases
Central Nervous System Diseases
Headache Disorders
Headache Disorders, Primary
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms
Zonisamide
Anticonvulsants
Antioxidants
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014