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This study has been withdrawn prior to enrollment.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
  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 (Subject, 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 ] [ 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:
    Drug: zonisamide
    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
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

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 July 29, 2014