Conditions: Symptomatic Neurogenic Orthostatic Hypotension Parkinson's Disease Multiple Systems Atrophy Pure Autonomic Failure Dopamine Beta Hydroxylase Deficiency
Keywords: NOH OH PD MSA PAF DBH
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 61
Healthy volunteers: no

Brief summary:
Evaluate the clinical efficacy and safety of droxidopa versus placebo over a 17 week (maximum) treatment period in patients with symptomatic NOH.

Detailed description:
This is a multi-center, multi-national, randomized, parallel-group, placebo-controlled, double-blind study with a 17 week (maximum) treatment period consisting of an initial, open-label dose titration (up to 2 weeks), followed by a washout period (up to 3 weeks), followed by a 12 week treatment period on a stable dose.

Arms:
arm 1: Droxidopa 100 mg, 200 mg, 300 mg arm 2: Placebo

Interventions: intervention 1: Droxidopa intervention 2: Placebo
Intervention descriptions: intervention 1: Droxidopa at 100 mg, 200 mg, 300 mg intervention 2: Placebo to match droxidopa capsules and strength designations

Protocol document: