Zonisamide for Fibromyalgia & Migraine

This study has been withdrawn prior to enrollment.

(Logistical problems prevented enrollment)

Sponsor:

Collaborator:

Eisai Inc.

Information provided by:

University of Pittsburgh

ClinicalTrials.gov Identifier:

NCT00259636

First received: November 26, 2005

Last updated: May 31, 2011

Last verified: May 2011

History of Changes

Purpose

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

Condition	Intervention	Phase
Fibromyalgia Migraine	Drug: zonisamide	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Investigator) Primary Purpose: Treatment
Official Title:	Zonisamide for Fibromyalgia & Migraine

Resource links provided by NLM:

MedlinePlus related topics: Fibromyalgia 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 ]
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 ]
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 ]
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 ]
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 (Adult)
Sexes Eligible for Study:	All
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

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: 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


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

Additional relevant MeSH terms:


Migraine Disorders Fibromyalgia Myofascial Pain Syndromes Headache Disorders, Primary Headache Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Muscular Diseases	Musculoskeletal Diseases Rheumatic Diseases Neuromuscular Diseases Zonisamide Anticonvulsants Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 18, 2017

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