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NCT01927055 · ClinicalTrials.gov registry record · Phase 3

A Clinical Study of Patients With Symptomatic NOH to Assess Sustained Effects of Droxidopa Therapy

A Phase 3 study, sponsored by Chelsea Therapeutics.

Terminated
Registry status
Phase 3
Development phase
61
Enrollment target

NCT01927055: Clinical Trial Phase 3 study, sponsored by Chelsea Therapeutics.

NCT01927055 is a Phase 3 study that was terminated before completion, run by Chelsea Therapeutics. The registered enrollment target is 61 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01927055, a Phase 3 study, was terminated before completion, sponsored by Chelsea Therapeutics.

TERMINATED
Registry status
Phase 3
Development phase
61 participants
Enrollment target

Study Summary

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

Primary Outcome

OHSA item 1 scale range: 0 (none) -10 (worst), likert scale. Change: score at end of study minus score at randomization. A positive score indicates worsening during the double-blind randomized phase relative to value at randomization, while a negative score indicates an improvement in symptom severity.

Interventions

  • DRUG Placebo
  • DRUG Droxidopa

Trial Details

FieldValue
Enrollment Target 61 participants
Start Date 2013-11
Est. Completion 2015-02
Phase Phase 3
Chelsea Therapeutics

10 total trials

Why NCT01927055 stopped before completion

NCT01927055 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT01927055 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01927055 about?

NCT01927055 is a clinical study titled "A Clinical Study of Patients With Symptomatic NOH to Assess Sustained Effects of Droxidopa Therapy". Evaluate the clinical efficacy and safety of droxidopa versus placebo over a 17 week (maximum) treatment period in patients with symptomatic NOH.

What is the current status of trial NCT01927055?

This trial is currently terminated. It is a Phase 3 study. The enrollment target is 61 participants. The study started on 2013-11. Estimated completion is 2015-02.

What interventions are being tested in trial NCT01927055?

The interventions under investigation include: Placebo (DRUG), Droxidopa (DRUG).

Who is sponsoring clinical trial NCT01927055?

This trial is sponsored by Chelsea Therapeutics, which has 10 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01927055's enrollment target sits among peer trials

61 1803rd of 2000 higher than 197 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01927055, the US trial registry maintained by the National Library of Medicine. NCT01927055 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.