Efficacy of L-threo DOPS on Orthostatic Hypotension Symptoms and Other Non-motor Symptoms in Pati… (NCT02071459) | Clinical Trial Compass
CompletedPhase 2/3
Efficacy of L-threo DOPS on Orthostatic Hypotension Symptoms and Other Non-motor Symptoms in Patients With MSA
France107 participantsStarted 2014-01-21
Plain-language 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.
Who can participate
Age range30 Years – 80 Years
SexALL
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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
What they're measuring
1
Evaluate the efficacy of long term efficacy of L-threo DOPS