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Zonisamide for Fibromyalgia & Migraine

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ClinicalTrials.gov Identifier: NCT00259636
Recruitment Status : Withdrawn (Logistical problems prevented enrollment)
First Posted : November 29, 2005
Last Update Posted : June 1, 2011
Sponsor:
Collaborator:
Eisai Inc.
Information provided by:
University of Pittsburgh

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

Condition or disease Intervention/treatment Phase
Fibromyalgia Migraine Drug: zonisamide Phase 4

Detailed Description:
Study was not conducted due to logistical problems

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Zonisamide for Fibromyalgia & Migraine
Study Start Date : August 2004
Actual Primary Completion Date : January 2008
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Zonisamide
U.S. FDA Resources


Intervention Details:
    Drug: zonisamide
    zonisamide 100 mg -300 mg daily vs placebo


Primary Outcome Measures :
  1. 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

  2. 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

  3. 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 :
  1. 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



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Dawn Marcus, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00259636     History of Changes
Other Study ID Numbers: EISAI 51-345-749
First Posted: November 29, 2005    Key Record Dates
Last Update Posted: June 1, 2011
Last Verified: May 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