Back to resultsZonisamide for Fibromyalgia & Migraine
Primary Purpose
Fibromyalgia, Migraine
Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
zonisamide
Sponsored by
About this trial
This is an interventional treatment trial for Fibromyalgia
Eligibility Criteria
Inclusion Criteria: 18-65 with fibromyalgia & migraine Exclusion Criteria: allergy sulfa, liver or kidney disease, pregnant or not using contraception
Sites / Locations
- University of Pittsburgh
Outcomes
Primary Outcome Measures
Visual analogue score
assessment measures at study enrollment (pre-treatment), and after 2, 4, and 8 weeks of treatment
Tender point count
assessment measures at study enrollment (pre-treatment), and after 2, 4, and 8 weeks of treatment
Headache index
assessment measures at study enrollment (pre-treatment), and after 2, 4, and 8 weeks of treatment
Secondary Outcome Measures
Sleep efficiency
assessment measures at study enrollment (pre-treatment), and after 2, 4, and 8 weeks of treatment
Full Information
NCT ID
NCT00259636
First Posted
November 26, 2005
Last Updated
May 31, 2011
Sponsor
University of Pittsburgh
Collaborators
Eisai Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00259636
Brief Title
Zonisamide for Fibromyalgia & Migraine
Official Title
Zonisamide for Fibromyalgia & Migraine
Study Type
Interventional
2. Study Status
Record Verification Date
May 2011
Overall Recruitment Status
Withdrawn
Why Stopped
Logistical problems prevented enrollment
Study Start Date
August 2004 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Pittsburgh
Collaborators
Eisai Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Patients with fibromyalgia & migraine are randomized to receive zonisamide or placebo.
Detailed Description
Study was not conducted due to logistical problems
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia, Migraine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
zonisamide
Intervention Description
zonisamide 100 mg -300 mg daily vs placebo
Primary Outcome Measure Information:
Title
Visual analogue score
Description
assessment measures at study enrollment (pre-treatment), and after 2, 4, and 8 weeks of treatment
Time Frame
assessment measures at study enrollment (pre-treatment), and after 2, 4, and 8 weeks of treatment
Title
Tender point count
Description
assessment measures at study enrollment (pre-treatment), and after 2, 4, and 8 weeks of treatment
Time Frame
assessment measures at study enrollment (pre-treatment), and after 2, 4, and 8 weeks of treatment
Title
Headache index
Description
assessment measures at study enrollment (pre-treatment), and after 2, 4, and 8 weeks of treatment
Time Frame
assessment measures at study enrollment (pre-treatment), and after 2, 4, and 8 weeks of treatment
Secondary Outcome Measure Information:
Title
Sleep efficiency
Description
assessment measures at study enrollment (pre-treatment), and after 2, 4, and 8 weeks of treatment
Time Frame
assessment measures at study enrollment (pre-treatment), and after 2, 4, and 8 weeks of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18-65 with fibromyalgia & migraine
Exclusion Criteria:
allergy sulfa, liver or kidney disease, pregnant or not using contraception
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dawn Marcus, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15206
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Zonisamide for Fibromyalgia & Migraine
We'll reach out to this number within 24 hrs