Zonisamide for Fibromyalgia & Migraine - Tabular View

Tracking Information

First Received Date ^ICMJE

November 26, 2005

Last Updated Date

November 11, 2008

Start Date ^ICMJE

August 2004

Primary Completion Date

January 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Visual analogue score
Tender point count
Headache index

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00259636 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Sleep efficiency

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Zonisamide for Fibromyalgia & Migraine

Official Title ^ICMJE

Zonisamide for Fibromyalgia & Migraine

Brief Summary

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

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Randomized, Double-Blind, Placebo Control, Parallel Assignment

Condition ^ICMJE

Fibromyalgia
Migraine

Intervention ^ICMJE

Drug: zonisamide

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

Primary Completion Date

January 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

18-65 with fibromyalgia & migraine

Exclusion Criteria:

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00259636

Responsible Party

Study ID Numbers ^ICMJE

EISAI 51-345-749

Study Sponsor ^ICMJE

University of Pittsburgh

Collaborators ^ICMJE

Eisai Inc.

Investigators ^ICMJE

Principal Investigator:

Dawn Marcus, MD

University of Pittsburgh

Information Provided By

University of Pittsburgh

Verification Date

November 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP