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Zonisamide for Fibromyalgia & Migraine
This study has been completed.
Sponsors and Collaborators: University of Pittsburgh
Eisai Medical Research Inc.
Information provided by: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00259636
  Purpose

Patients with fibromyalgia & migraine are randomized to receive zonisamide or placebo.


Condition Intervention Phase
Fibromyalgia
Migraine
Drug: zonisamide
Phase IV

Genetics Home Reference related topics: familial hemiplegic migraine
MedlinePlus related topics: Fibromyalgia Headache Migraine
Drug Information available for: Zonisamide
U.S. FDA Resources
Study Type: Interventional
Study Design: Randomized, Double-Blind, Placebo Control, Parallel Assignment
Official Title: Zonisamide for Fibromyalgia & Migraine

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Visual analogue score
  • Tender point count
  • Headache index

Secondary Outcome Measures:
  • Sleep efficiency

Estimated Enrollment: 50
Study Start Date: August 2004
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • 18-65 with fibromyalgia & migraine

Exclusion Criteria:

  • allergy sulfa, liver or kidney disease, pregnant or not using contraception
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00259636

Locations
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15206
Sponsors and Collaborators
University of Pittsburgh
Eisai Medical Research Inc.
Investigators
Principal Investigator: Dawn Marcus, MD University of Pittsburgh
  More Information

Study ID Numbers: EISAI 51-345-749
Study First Received: November 26, 2005
Last Updated: November 11, 2008
ClinicalTrials.gov Identifier: NCT00259636  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Fibromyalgia
Myofascial Pain Syndromes
Zonisamide
Central Nervous System Diseases
Pain
Headache Disorders, Primary
Rheumatic Diseases
Brain Diseases
Headache Disorders
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Migraine Disorders
Headache

Additional relevant MeSH terms:
Antioxidants
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Physiological Effects of Drugs
Nervous System Diseases
Central Nervous System Agents
Protective Agents
Anticonvulsants
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009