A Multicentre Trial to Determine the Efficacy and Safety of AD-337 in the Treatment of Fibromyalgia

Sosei100 enrolled

Overview

This is a multicentre, randomized, double-blind, placebo controlled, parallel group exploratory study to investigate the efficacy, safety and tolerability of AD 337 in the treatment of fibromyalgia in female subjects.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

100

Conditions

Fibromyalgia

Interventions

AD 337DRUG

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Female * Age 18-65 * Meet ACR 1990 criteria for classification of Fibromyalgia * Able and willing to discontinue CNS active therapies Exclusion Criteria: * If pain is NOT primarily due to Fibromyalgia * Current or prior history of serious psychiatric disorder * Pregnant/breastfeeding * QTc \> 470ms * Failure to respond to 2 or more adequate regimes of different classes of antidepressants.

Locations (1)

David L Scott

London, United Kingdom

Outcomes

Primary Outcomes

The Fibromyalgia Impact Questionnaire total score after 4 weeks treatment

Secondary Outcomes

These will be

FIQ Total score at weeks 1, 2, 3, at end of study and overall

FIQ subscales at weeks 1, 2, 3, 4 at end of study and overall

Short form McGill Pain questionnaire subscales at weeks 1, 2, 3, 4 at end of study and overall

Tender point assessment (ACR 1990 criteria) scores at weeks 2, 4 at end of study and overall

Hospital Anxiety and Depression Scale subscales at weeks 2, 4 and overall

Fibromyalgia Health Assessment Questionnaire total score at weeks 1, 2, 3, 4 at end of study and overall

Data from ClinicalTrials.gov

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