Study To Assess The Clinical Benefit Of Droxidopa And Droxidopa/Carbidopa In Subjects With Fibromyalgia

PHASE2CompletedINTERVENTIONAL
Enrollment

122

Participants

Timeline

Start Date

January 31, 2009

Primary Completion Date

October 31, 2011

Study Completion Date

October 31, 2011

Conditions
Fibromyalgia
Interventions
DRUG

Droxidopa

Oral, 200mg, 400mg or 600mg TID, duration includes up to a 1 week blinded titration period followed by an 8 week treatment period.

DRUG

Carbidopa

Oral, 25mg, or 50mg TID, duration includes up to a 1 week blinded titration period followed by an 8 week treatment period.

DRUG

Droxidopa/carbidopa

Oral, 200mg/25mg, 400mg/25mg, 600mg/25mg, 200mg/50mg, 400mg/50mg, or 600mg/50mg TID. Duration includes up to a 1 week titration period followed by an 8 week treatment period.

DRUG

Placebo

Oral, placebo TID

Trial Locations (7)

S75 2EP

Rheumatology Department; Barnsley Hospital NHS Foundation Trust, Barnsley

L18 1HQ

MAC UK Neuroscience, Liverpool

SE5 9RJ

Academic Dept of Rheumatology, Kings College London, London

M32 0UT

MAC UK Neuroscience, Manchester

NE7 7DN

Musculoskeletal Department; Freeman Hospital, Newcastle upon Tyne

BH15 2JB

Rheumatology Department, Poole Hospital NHS Trust, Poole

M6 8HD

Clinical Trials Unit; Main Hospital; Salford Rooyal NHS Foundation Trust, Salford

Sponsors
All Listed Sponsors
lead

Chelsea Therapeutics

INDUSTRY