Study to assess the clinical benefit of Droxidopa in Fibromyalgia

• Research type

  Research Study

• Full title

  A PHASE II, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE-RESPONSE STUDY TO ASSESS THE CLINICAL BENEFIT OF DROXIDOPA AND DROXIDOPA/CARBIDOPA IN SUBJECTS WITH FIBROMYALGIA

• IRAS ID

  2174

• Sponsor organisation

  Chelsea Therapeutics, Inc

• Eudract number

  2008-001123-62

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  A correlation between increasednorepinephrine concentrations, in the central nervous system (CNS) and adecrease in fibromyalgia pain has been suggested in previous clinical studies.Therefore, as a pro-drug of norepinephrine, droxidopa could potentially benefitfibromyalgia (FM) patients. As this benefit is presumed to be a central effect,the addition of carbidopa, a peripheral decarboxylase inhibitor, may favorablyimpact the drug??s treatment profile as it would block peripheralactions andreduce potential side effects. Information is desired regarding the properdosing, effectiveness and safety of droxidopa and combinationdroxidopa/carbidopa treatments in patients with fibromyalgia. Hence the purposeof this research study is to determine whether Droxidopa alone, or inconjunction with Carbidopa, can relieve symptoms of FM and to look at the sideeffect profile of both combinations in people with FM

• REC name

  South Central - Oxford C Research Ethics Committee

• REC reference

  08/H0606/101

• Date of REC Opinion

  13 Nov 2008

• REC opinion

  Further Information Favourable Opinion