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

Status: Completed
Location: See all (13) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY

Evaluate the effects of L-Threo DOPS on orthostatic hypotension symptoms and other non-motor symptoms in patients with Multiple System Atrophy (MSA) after 12 weeks following randomization to continued therapy with droxidopa or placebo.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 30
Maximum Age: 80
Healthy Volunteers: No
View:

• MSA patients (possible or probable, MSA-P or C (according to revised criteria, Gilman et al 2008)).

• Aged 30 to 80 years,

• Able to walk at least 10 meters

• With symptomatic OH (score of at least 3 at one of the items of Part I of the OH scale (OHQ))

• Documented fall in systolic blood pressure of at least 20 mmHg, and/or in diastolic blood pressure of at least 10 mmHg, within 3 minutes after standing.

• Able to fill in the evaluation questionnaires with or without help

• With no significant problems with swallowing.

• Stable anti-parkinsonian, dysautonomia and depression treatments for the 4 weeks before the study and during the entire study

• Signed written informed consent for the present study.

Locations
Other Locations
France
Centre hospitalier d'Angers
Angers
CHU bordeaux
Bordeaux
CHU de Clermont-Ferrand
Clermont-ferrand
CHU de Dijon
Dijon
CHRU de lille
Lille
CHU de limoges
Limoges
Hôpital La Timone
Marseille
Hôpital G. & R. Laennec
Nantes
Hôpital Pitié-Salpétrière
Paris
CHU de Poitiers
Poitiers
CHU Pontchaillou
Rennes
CHU de Rouen
Rouen
chu de Strasbourg
Strasbourg
Time Frame
Start Date: January 21, 2014
Completion Date: October 28, 2019
Participants
Target number of participants: 107
Treatments
Experimental: L-Threo DOPS
patients with Multiple System Atrophy (MSA) after 12 weeks to continued therapy with L-Threo DOPS
Placebo Comparator: placebo
patients with Multiple System Atrophy (MSA) after 12 weeks to continued therapy with placebo
Sponsors
Leads: University Hospital, Toulouse

This content was sourced from clinicaltrials.gov

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