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

• Status: Completed
• Trial end date: 2007-08-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sosei

Criteria

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.