Efficacy of L-threo DOPS on Orthostatic Hypotension Symptoms and Other Non-motor Symptoms in Patients With MSA
DOPS-AMS
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
2 other identifiers
interventional
107
1 country
13
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2014
Longer than P75 for phase_2
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 21, 2014
CompletedFirst Submitted
Initial submission to the registry
February 21, 2014
CompletedFirst Posted
Study publicly available on registry
February 25, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 28, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 28, 2019
CompletedApril 8, 2026
April 1, 2026
5.8 years
February 21, 2014
April 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluate the efficacy of long term efficacy of L-threo DOPS
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).
12 weeks
Secondary Outcomes (4)
efficacy of L-ThreoDOPS on symptomatic OH
12 weeks
effects of L-Threo DOPS on motor symptoms
12 weeks
effect of L-Threo DOPS on dysautonomic symptoms
12 weeks
safety of high doses of L-ThreoDOPS
12 Weeks
Study Arms (2)
L-Threo DOPS
EXPERIMENTALpatients with Multiple System Atrophy (MSA) after 12 weeks to continued therapy with L-Threo DOPS
placebo
PLACEBO COMPARATORpatients with Multiple System Atrophy (MSA) after 12 weeks to continued therapy with placebo
Interventions
initial dose titration period (4 weeks) followed by 8 weeks at the max tolerated dose
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Dementia (DSM-IV, Mini-Mental State Examination (MMSE) \< 24/30)
- Concomitant use of vaso-constrictive drugs, other than midodrine. Patients taking vasoconstrictor agents such as ephedrine, dihydroergotamine, must stop taking these drugs at least 2 days or 7 half-lives prior to their baseline visit (Visit 1); the association with midodrine may be kept at a stable dose not exceeding 3 tablets (7.5 mg) / day if the patient has no CV history. This will be discussed case by case with the coordinating center and the safety committee of this study.
- Taking anti-hypertensive medication
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Centre hospitalier d'Angers
Angers, 49933, France
CHU bordeaux
Bordeaux, France
CHU de Clermont-Ferrand
Clermont-Ferrand, 63000, France
CHU de Dijon
Dijon, 21000, France
CHRU de lille
Lille, 59037, France
CHU de limoges
Limoges, 87042, France
Hôpital La Timone
Marseille, 13000, France
Hôpital G. & R. Laennec
Nantes, 44093, France
Hôpital Pitié-Salpétrière
Paris, 75013, France
CHU de Poitiers
Poitiers, 86021, France
CHU Pontchaillou
Rennes, 35033, France
CHU de Rouen
Rouen, 76031, France
chu de Strasbourg
Strasbourg, 67091, France
Related Publications (1)
Dierickx LO, Bettiol C, Huglo D, Marcelli F, Sibert L, Gouel P, Ferretti L, Orlhac F, Huyghe E. Is 18F-fluorodexyglucose testicular uptake using positron emission tomography/computed tomography correlated with the results of a testicular sperm extraction procedure in the case of azoospermia (French prospective multicenter AZOPREDHISTOTEP study)? Eur J Nucl Med Mol Imaging. 2026 Apr;53(5):3283-3290. doi: 10.1007/s00259-025-07583-7. Epub 2025 Nov 21.
PMID: 41269291RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anne PAVY-LE-TRAON, PHD
University Hospital, Toulouse
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 21, 2014
First Posted
February 25, 2014
Study Start
January 21, 2014
Primary Completion
October 28, 2019
Study Completion
October 28, 2019
Last Updated
April 8, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share