CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 350 enrolled
Drug / intervention
Droxidopadrug
Likely dose
Droxidopa 600 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.

Search/NCT01132326
NCT01132326Phase 3Completed
CompareCT.gov

A Multi-center, Open-label Study to Assess the Long-term Safety of Droxidopa in Subjects With Primary Autonomic Failure, Dopamine Beta Hydroxylase Deficiency or Non-Diabetic Neuropathy and Symptomatic Neurogenic Orthostatic Hypotension

Chelsea Therapeutics·interventional·Posted May 28, 2010·Updated Feb 9, 2024

In Brief

A Phase 3 clinical trial evaluating Droxidopa for Primary Autonomic Failure and 3 related conditions. Completed, enrolled 350 participants.

Detailed Summary

Symptomatic NOH in patients with primary autonomic failure is thought to be a consequence of norepinephrine depletion leading to a diminished capacity to effect an appropriate cardiovascular response to an orthostatic challenge resulting in symptomatic cerebral-hypoperfusion. Droxidopa augments norepinephrine levels which should lead to improved cerebral perfusion following orthostatic challenge thereby reducing the symptoms of NOH. The present study will evaluate the long-term safety of droxidopa.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrimary Autonomic Failure, Dopamine Beta Hydroxylase Deficiency, Non-Diabetic Neuropathy, Neurogenic Orthostatic Hypotension
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 28, 2010
Enrollment StartJan 1, 2009
Primary CompletionFeb 1, 2013
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 16.1 years ago

Interventions

Droxidopadrug

Oral, 100, 200, 300, 400, 500, 600 mg TID, 12 months