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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02071459
• Date of registration: 21/02/2014
• Prospective Registration: No
• Primary sponsor: University Hospital, Toulouse
• Public title: Efficacy of L-threo DOPS on Orthostatic Hypotension Symptoms and Other Non-motor Symptoms in Patients With MSA DOPS-AMS
• Scientific title: 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
• Date of first enrolment: January 21, 2014
• Target sample size: 107
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02071459
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2/Phase 3

Countries of recruitment

France

Contacts

• Name: Anne PAVY-LE-TRAON, PHD
• Affiliation: CHU Toulouse

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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



Age minimum: 30 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Multiple System Atrophy

Intervention(s)

Drug: L-Threo DOPS

Drug: placebo

Primary Outcome(s)

Evaluate the efficacy of long term efficacy of L-threo DOPS [Time Frame: 12 weeks]

Secondary Outcome(s)

effect of L-Threo DOPS on dysautonomic symptoms [Time Frame: 12 weeks]

effects of L-Threo DOPS on motor symptoms [Time Frame: 12 weeks]

efficacy of L-ThreoDOPS on symptomatic OH [Time Frame: 12 weeks]

safety of high doses of L-ThreoDOPS [Time Frame: 12 Weeks]

Secondary ID(s)

12 554 01

12-018-0200

Source(s) of Monetary Support

Please refer to primary and secondary sponsors