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Zonisamide for Fibromyalgia & Migraine

This study has been withdrawn prior to enrollment.
(Logistical problems prevented enrollment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00259636
First Posted: November 29, 2005
Last Update Posted: June 1, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Eisai Inc.
Information provided by:
University of Pittsburgh
  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 (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Zonisamide for Fibromyalgia & Migraine

Resource links provided by NLM:


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:
    Drug: zonisamide
    zonisamide 100 mg -300 mg daily vs placebo
Detailed Description:
Study was not conducted due to logistical problems
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
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
  More Information

Responsible Party: Dawn Marcus, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00259636     History of Changes
Other Study ID Numbers: EISAI 51-345-749
First Submitted: November 26, 2005
First Posted: November 29, 2005
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