Zonisamide for Fibromyalgia & Migraine

This study has been completed.

First Received: November 26, 2005 Last Updated: November 11, 2008 History of Changes

Sponsor:	University of Pittsburgh
Collaborator:	Eisai 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

Study Type:	Interventional
Study Design:	Randomized, Double-Blind, Placebo Control, Parallel Assignment
Official Title:	Zonisamide for Fibromyalgia & Migraine

Resource links provided by NLM:

Genetics Home Reference related topics: familial hemiplegic migraine

MedlinePlus related topics: Fibromyalgia Headache Migraine

Drug Information available for: Zonisamide

U.S. FDA Resources

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 Inc.

Investigators

Principal Investigator:

Dawn Marcus, MD

University of Pittsburgh

More Information

No publications provided

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

Additional relevant MeSH terms:

Antioxidants
Molecular Mechanisms of Pharmacological Action
Fibromyalgia
Myofascial Pain Syndromes
Physiological Effects of Drugs
Nervous System Diseases
Zonisamide
Central Nervous System Diseases
Headache Disorders, Primary
Rheumatic Diseases
Brain Diseases

Protective Agents
Pharmacologic Actions
Headache Disorders
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Migraine Disorders
Therapeutic Uses
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on November 05, 2009