Zonisamide for Fibromyalgia & Migraine

Phase 4WithdrawnNCT00259636

University of Pittsburgh

Overview

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

Study was not conducted due to logistical problems

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

Fibromyalgia Migraine

Interventions

zonisamideDRUG

zonisamide 100 mg -300 mg daily vs placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 18-65 with fibromyalgia \& migraine Exclusion Criteria: * allergy sulfa, liver or kidney disease, pregnant or not using contraception

Locations (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Outcomes

Primary Outcomes

Visual analogue score

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

Tender point count

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

Headache index

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 Outcomes

Sleep efficiency

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

Data from ClinicalTrials.gov

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