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

A Multi-Centre, Randomised, 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.

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.

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.