Zonisamide in Migraine and Fibromyalgia - Clinical Trials Registry

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Drug: zonisamide

Detailed Description

Study was not conducted due to logistical problems

Study Type

Interventional

Phase

Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Pennsylvania
  - Pittsburgh, Pennsylvania, United States, 15206
    - University of Pittsburgh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

18-65 with fibromyalgia & migraine

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	assessment measures at study enrollment (pre-treatment), and after 2, 4, and 8 weeks of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	assessment measures at study enrollment (pre-treatment), and after 2, 4, and 8 weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Collaborators

Eisai Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2004

Primary Completion (ACTUAL)

January 1, 2008

Study Completion (ACTUAL)

January 1, 2008

Study Registration Dates

First Submitted

November 26, 2005

First Submitted That Met QC Criteria