Zonisamide for Fibromyalgia & Migraine

Zonisamide for Fibromyalgia & Migraine

Sponsors

Lead Sponsor: University of Pittsburgh

Collaborator: Eisai Inc.

Source University of Pittsburgh
Brief Summary

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

Detailed Description

Study was not conducted due to logistical problems

Overall Status Withdrawn
Start Date August 2004
Completion Date January 2008
Primary Completion Date January 2008
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
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
Measure Time Frame
Sleep efficiency assessment measures at study enrollment (pre-treatment), and after 2, 4, and 8 weeks of treatment
Condition
Intervention

Intervention Type: Drug

Intervention Name: zonisamide

Description: zonisamide 100 mg -300 mg daily vs placebo

Eligibility

Criteria:

Inclusion Criteria:

- 18-65 with fibromyalgia & migraine

Exclusion Criteria:

- allergy sulfa, liver or kidney disease, pregnant or not using contraception

Gender: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Dawn Marcus, MD Principal Investigator University of Pittsburgh
Location
Facility: University of Pittsburgh
Location Countries

United States

Verification Date

May 2011

Responsible Party

Name Title: Dawn Marcus

Organization: University of Pittsburgh

Has Expanded Access No
Condition Browse
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov