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

Sosei

Status and phase: Completed; Phase 2

Conditions: Fibromyalgia

Treatments: Drug: AD 337

Study type: Interventional

Funder types: Industry

Identifiers

NCT00377039

AD337-021

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind