Zonisamide for Fibromyalgia & Migraine - Full Text View

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:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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 [ Time Frame: assessment measures at study enrollment (pre-treatment), and after 2, 4, and 8 weeks of treatment ] [ Designated as safety issue: No ]
assessment measures at study enrollment (pre-treatment), and after 2, 4, and 8 weeks of treatment
Tender point count [ Time Frame: assessment measures at study enrollment (pre-treatment), and after 2, 4, and 8 weeks of treatment ] [ Designated as safety issue: No ]
assessment measures at study enrollment (pre-treatment), and after 2, 4, and 8 weeks of treatment
Headache index [ Time Frame: assessment measures at study enrollment (pre-treatment), and after 2, 4, and 8 weeks of treatment ] [ Designated as safety issue: No ]
assessment measures at study enrollment (pre-treatment), and after 2, 4, and 8 weeks of treatment

Secondary Outcome Measures:

Sleep efficiency [ Time Frame: assessment measures at study enrollment (pre-treatment), and after 2, 4, and 8 weeks of treatment ] [ Designated as safety issue: No ]
assessment measures at study enrollment (pre-treatment), and after 2, 4, and 8 weeks of treatment

Enrollment:	0
Study Start Date:	August 2004
Study Completion Date:	January 2008
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Intervention Details:

zonisamide 100 mg -300 mg daily vs placebo

Detailed Description:

Study was not conducted due to logistical problems

Eligibility

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

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

Responsible Party:	Dawn Marcus, University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00259636 History of Changes
Other Study ID Numbers:	EISAI 51-345-749
Study First Received:	November 26, 2005
Last Updated:	May 31, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Fibromyalgia
Myofascial Pain Syndromes
Migraine Disorders
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Headache Disorders, Primary
Headache Disorders
Brain Diseases

Central Nervous System Diseases
Zonisamide
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012