patients with Multiple System Atrophy (MSA) after 12 weeks to continued therapy with L-Threo DOPS

patients with Multiple System Atrophy (MSA) after 12 weeks to continued therapy with placebo

Multiple System Atrophy

initial dose titration period (4 weeks) followed by 8 weeks at the max tolerated dose

L-Threo DOPS

initial period (4 weeks) followed by 8 weeks

placebo

Centre hospitalier d'Angers

CHU bordeaux

CHU de Clermont-Ferrand

CHU de Dijon

CHRU de lille

CHU de limoges

Hôpital La Timone

Hôpital G. & R. Laennec

Hôpital Pitié-Salpétrière

CHU de Poitiers

CHU Pontchaillou

CHU de Rouen

chu de Strasbourg

Efficacy of L-threo DOPS on Orthostatic Hypotension Symptoms and Other Non-motor Symptoms in Patients With MSA

Evaluate the Long-term (3 Months) Efficacy of L-threo DOPS (DroxiDopa) on Orthostatic Hypotension Symptoms and Other Non-motor Symptoms in Patients With Multiple System Atrophy (MSA). Comparative Study Versus Placebo

Evaluate the efficacy of long term efficacy of L-threo DOPS (droxidopa) in MSA patients (probable or possible - cerebellar (C) or parkinsonian (P) type) with symptomatic NOH as measured by the relative change in mean score of Orthostatic Hypotension Symptom Assessment (OHSA) (Part I of the questionnaire on the symptoms OH (OHQ) (Kaufmann et al., 2011)) 12 weeks following randomization to therapy with droxidopa or placebo (including 8 weeks to maximum tolerated dose).

Evaluate and compare the efficacy of L-ThreoDOPS on symptomatic OH (measured by the relative change in mean score of Item 1 of the Orthostatic Hypotension Symptom Assessment (OHSA)) in MSA patients 4, 8 and 12 weeks following randomization to continued therapy with droxidopa or placebo

Evaluate the effects of L-Threo DOPS on motor symptoms (UMSARS I and II) in MSA patients after 12 weeks following randomization to continued therapy with droxidopa or placebo

Evaluate the effect of L-Threo DOPS on dysautonomic symptoms (COMPASS) in MSA patients after 4, 8 and 12 weeks following randomization to continued therapy with droxidopa or placebo

Determine the safety of high doses of L-ThreoDOPS in MSA patients based on the occurrence of treatment-emergent adverse events

University Hospital, Toulouse

Fibromyalgia

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

Droxidopa

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

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.

Droxidopa/carbidopa

Placebo

Rheumatology Department; Barnsley Hospital NHS Foundation Trust

MAC UK Neuroscience

Academic Dept of Rheumatology, Kings College London

Musculoskeletal Department; Freeman Hospital

Rheumatology Department, Poole Hospital NHS Trust

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

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

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

dopa decarboxylase/fatigue

Efficacy of L-threo DOPS on Orthostatic Hypotension Symptoms and Other Non-motor Symptoms in Patients With MSA

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

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