Zonisamide for Fibromyalgia & Migraine

Phase 4

Withdrawn

• Conditions: Fibromyalgia; Migraine

• Registration Number: NCT00259636
• Lead Sponsor: 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

Study Timeline

• Study Start: 2004-08
• Study First Submitted: 2005-11-26
• Study First Submitted QC: 2005-11-26
• Study First Posted: 2005-11-29
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-31
• Last Update Posted: 2011-06-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• 18-65 with fibromyalgia & migraine

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Visual analogue score	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	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	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

Name	Time	Method
Sleep efficiency	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

Trial Locations

Locations (1)

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States