Reboxetine Fibromyalgia Syndrome trial

A major trial of the drug Reboxetine for Fibromyalgia Syndrome (Fibro) is currently recruiting patients in the USA and Canada.

The 14 week randomised double-blind Phase III trial, sponsored by Pfizer, will recruit around 1150 Fibro patients in 120 locations across the USA and Canada. Pfizer estimate that the trial will be completed in April 2009.

Primary outcome measures for the trial will be the change from baseline in the endpoint mean pain score and the multidimensional assessment of fatigue. Secondary outcome measures will be: the change from baseline in the endpoint mean sleep interference score; the Patient Global Impression of Change; the Fibromylagia Impact Questionnaire; the Hospital Anxiety and Depression Scale; the Short Form 36 Health Questionnaire; the Sheehan Disability Score; and the Pain Visual Analogue Scale.

Reboxetine is in a class of medications known as selective norepinephrine reuptake inhibitors (NARIs).

Pfizer said in the clinical trial submission that:

"A previous study demonstrated clinically meaningful treatment effects in fibromyalgia, based on pain and functional endpoints."