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

• Status: Completed
• Trial end date: 2019-10-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Toulouse
• Treatments: Droxidopa

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