At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 453 enrolled
Drug / intervention
Droxidopa capsules +1 moredrug
Likely dose
Droxidopa capsules 300 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
RESTORE: A Clinical Study of Patients With Symptomatic Neurogenic Orthostatic Hypotension to Assess Sustained Effects of Droxidopa Therapy
In Brief
A Phase 4 clinical trial evaluating Droxidopa capsules and Placebo capsules for Symptomatic Neurogenic Orthostatic Hypotension. Completed, enrolled 453 participants across 168 sites.
Detailed Summary
To evaluate the time to treatment intervention in patients with Parkinson's Disease (PD), Multiple System Atrophy (MSA), Pure Autonomic Failure (PAF), Non-Diabetic Autonomic Neuropathy (NDAN) or Dopamine Beta Hydroxylase (DBH) Deficiency who have been previously stabilized with droxidopa therapy for symptoms of neurogenic orthostatic hypotension (NOH) (dizziness, light-headedness, or feelings that they are about to black out)
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedOct 2015
Enrollment StartFeb 2016
Primary CompletionJul 2022
Study CompletionSep 2022
TodayJul 2026
First PostedOct 26, 2015
Enrollment StartFeb 11, 2016
Primary CompletionJul 21, 2022
Study CompletionSep 9, 2022
TodayJul 2, 2026
Enrollment to primary: 6.4 yearsPosted 10.7 years ago
Interventions
Droxidopa capsulesdrug
100, 200 or 300 mg
Placebo capsulesdrug