Trial · NCT01927055

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

NCT01927055, Phase 3, Terminated, Chelsea Therapeutics; results first posted 2016-01-08

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Clinical Study of Patients With Symptomatic NOH to Assess Sustained Effects of Droxidopa Therapy. Trials, record NCT01927055. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01927055

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Clinical Study of Patients With Symptomatic NOH to Assess Sustained Effects of Droxidopa Therapy
NCT number: NCT01927055
Status: Terminated
Phases: Phase 3
Enrollment: 61 participants, actual
Lead sponsor: Chelsea Therapeutics
Conditions: Symptomatic Neurogenic Orthostatic Hypotension, Parkinson's Disease, Multiple Systems Atrophy, Pure Autonomic Failure, Dopamine Beta Hydroxylase Deficiency
Interventions: Droxidopa, Placebo
First posted: 2013-08-22
Last updated: 2016-01-08
Results first posted: 2016-01-08
Limitations and caveats: The study was prematurely terminated; the limited sample size precludes meaningful conclusions on the efficacy or safety of droxidopa in this study.

Source ClinicalTrials.gov

Registered outcomes1

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in Dizziness/ Lightheadedness/ Feeling Faint/ or Feeling Like You Might Blackout (OHSA Item 1)	Change from Randomization to Week 1	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.

Source ClinicalTrials.gov

Outcomes1

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in Dizziness/ Lightheadedness/ Feeling Faint/ or Feeling Like You Might Blackout (OHSA Item 1)	Change from Randomization to Week 1	Patients entering the double-blind, randomized phase and having a visit at week 1 of the double-blind phase were analyzed.~Study was stopped when only 5% of planned participants had completed the study to prevent competition with FDA mandated post-marketing requirement study.	units on a scale	MEAN

Source ClinicalTrials.gov

Results by group2

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change in Dizziness/ Lightheadedness/ Feeling Faint/ or Feeling Like You Might Blackout (OHSA Item 1)	Droxidopa		-1.1	Standard Deviation 3.2	units on a scale
Change in Dizziness/ Lightheadedness/ Feeling Faint/ or Feeling Like You Might Blackout (OHSA Item 1)	Placebo		-0.5	Standard Deviation 1.8	units on a scale

Source ClinicalTrials.gov

Participant flow18

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Open-label	STARTED	Open-label Titration	61
Open-label	STARTED	Droxidopa	0
Open-label	STARTED	Placebo	0
Open-label	COMPLETED	Open-label Titration	45
Open-label	COMPLETED	Droxidopa	0
Open-label	COMPLETED	Placebo	0
Open-label	NOT COMPLETED	Open-label Titration	16
Open-label	NOT COMPLETED	Droxidopa	0
Open-label	NOT COMPLETED	Placebo	0
Double-Blind	STARTED	Open-label Titration	0

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events48

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Headache	Nervous system disorders	Open-label Titration	5	61	5
other	Headache	Nervous system disorders	Droxidopa	1	22	1
other	Headache	Nervous system disorders	Placebo	1	23	1
other	Dizziness	Nervous system disorders	Open-label Titration	3	61	3
other	Dizziness	Nervous system disorders	Droxidopa	2	22	2
other	Dizziness	Nervous system disorders	Placebo	0	23	0
other	Laceration	Injury, poisoning and procedural complications	Open-label Titration	1	61	1
other	Laceration	Injury, poisoning and procedural complications	Droxidopa	2	22	6
other	Laceration	Injury, poisoning and procedural complications	Placebo	2	23	2
other	Fatigue	General disorders	Open-label Titration	0	61	0

1 to 10 of 48Source ClinicalTrials.gov

See all 48 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Open-label Titration
Total, all-cause mortality	Droxidopa
Total, all-cause mortality	Placebo
Total, other adverse events	Open-label Titration	17	61
Total, other adverse events	Droxidopa	7	22
Total, other adverse events	Placebo	5	23
Total, serious adverse events	Open-label Titration	3	61
Total, serious adverse events	Droxidopa	1	22
Total, serious adverse events	Placebo	3	23

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01927055

GET https://conductscience.org/api/trials/v1/NCT01927055/events?page=2

API reference For AI assistants