To evaluate the maintenance of efficacy of a new investigational treatment compared with placebo in the management of fibromyalgia as measured by pain and overall fibromyalgia symptoms.
Some qualifications will be required, other may apply:
- No Complex regional pain syndrome, failed back surgery syndrome, persistent or prevalent pain symptoms related to systemic disease (e.g., DPN and PHN), untreated hyperparathyroidism, or a history of prior surgery, trauma or other sources of pain
- Failed at least two courses of treatment with either tricyclic antidepressants or SNRI agents for fibromyalgia (i.e. duloxetine- Cymbalta or milnacipran – Savella, or Effexor)
- Use of any herbal supplements, or any dietary products/supplements with potential central nervous system activity (including kava, SAMe, valerian root, DHEA, tyrosine, and 5-HTP), within 2 weeks of screening appointment
- No cost to participate or need for medical insurance. Compensation up to $1550 if you complete the trial.
- The study will span approximately 30 weeks (Around 7 months) duration. It comprises of a 4-week Screening period, followed by 12 weeks where you receive treatment, then 12 weeks of the double-blind randomized/withdrawal period where you may or may not receive treatment, followed by 2 weeks of follow up.