Trial · NCT00738062

Open-Label Clinical Study of Droxidopa in Patients With Neurogenic Orthostatic Hypotension (NOH)

NCT00738062, Phase 3, Completed, Chelsea Therapeutics; results first posted 2014-05-16

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Open-Label Clinical Study of Droxidopa in Patients With Neurogenic Orthostatic Hypotension (NOH). Trials, record NCT00738062. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00738062

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Trial

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

Title: Open-Label Clinical Study of Droxidopa in Patients With Neurogenic Orthostatic Hypotension (NOH)
NCT number: NCT00738062
Status: Completed
Phases: Phase 3
Enrollment: 103 participants, actual
Lead sponsor: Chelsea Therapeutics
Conditions: Neurogenic Orthostatic Hypotension, Non-Diabetic Autonomic Neuropathy, Multiple System Atrophy, Dopamine Beta Hydroxylase Deficiency
Interventions: Droxidopa, Placebo
First posted: 2008-08-20
Last updated: 2014-05-16
Results first posted: 2014-05-16

Source ClinicalTrials.gov

Registered outcomes8

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

List	Outcome	Time frame	Description
Primary	Change in Orthostatic Hypotension Questionnaire Composite Score (OHQ)	14 days	The OHQ is the average of two sub-scales, the Orthostatic Hypotension Symptom Assessment Scale (OHSA) and the Orthostatic Hypotension Daily Activities Scale (OHDAS). Each asks the patient to rate their symptoms or disease impact over the past week. The OHSA sub-scale is the average of six items: 1) Dizziness, lightheadedness, feeling faint or feeling like you might black out; 2) Problems with vision; 3) Weakness; 4) Fatigue; 5) Trouble concentrating; and 6) Head/neck discomfort. The OHDAS sub-scale is the average of four items: 1) Standing for a short time; 2) Standing for a long time; 3) Walking for a short time; and 4) Walking for a long time. Each item is scored on a Likert scale from 0 to 10, with 10 being the most severe. In this withdrawal design, a positive score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug). All patients are on open-label droxidopa for 3 months prior to randomization.
Secondary	Change in Orthostatic Hypotension Daily Activities (OHDAS) Score	14 days	The OHDAS scale is the average of four items: 1) Standing for a short time; 2) Standing for a long time; 3) Walking for a short time; and 4) Walking for a long time. Each asks the patient to rate their disease impact over the past week. Each item is scored on a Likert scale from 0 to 10, with 10 being the most severe. Change: score at end of randomization minus score at randomization. In this withdrawal design, a positive score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug).
Secondary	Change in Orthostatic Hypotension Symptom Assessment (OHSA) Composite Score	14 days	The OHSA scale is the average of six items: 1) Dizziness, lightheadedness, feeling faint or feeling like you might black out; 2) Problems with vision; 3) Weakness; 4) Fatigue; 5) Trouble concentrating; and 6) Head/neck discomfort. Each asks the patient to rate their symptoms over the past week. Each item is scored on a Likert scale from 0 to 10, with 10 being the most severe. Change: score at end of randomization minus score at randomization. In this withdrawal design, a positive score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug).
Secondary	Change in Systolic Blood Pressure (SBP) Measurements 3 Minutes Post Standing	14 days	Change: standing systolic blood pressure at end of study minus standing systolic blood pressure at randomization. In this withdrawal design, a negative score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug). All patients are on open-label droxidopa for 3 months prior to randomization to either continued droxidopa or to placebo.
Secondary	Patient Reported Clinical Global Impression - Severity	14 days	The CGI-S is a 7 point scale ranging from a score of 1 (no symptoms) to 7 (severe symptoms). Patients were grouped according to OH severity at the end of the randomization period as follows; * Normal-Borderline OH (CGI-S 1-2), * Mild-Moderate OH (CGI-S 3-4), * Marked OH-Most Ill with OH (CGI-S 5-7). .
Secondary	Clinician Recorded Clinical Global Impression - Severity	14 days	The CGI-S is a 7 point scale ranging from a score of 1 (no symptoms) to 7 (severe symptoms). Patients were grouped according to OH severity at the end of the randomization period as follows; * Normal-Borderline OH (CGI-S 1-2), * Mild-Moderate OH (CGI-S 3-4), * Marked OH-Most Ill with OH (CGI-S 5-7).
Secondary	Patient Reported Clinical Global Impression - Improvement	14 days	The CGI-I is a 7 point scale ranging from a score of 1 (very much improved) to 7 (very much worse), with no change in the middle, and assesses the improvement in relation to the baseline evaluation. Patients will be grouped according change in disease as follows; * Very Much Improved to Slightly Improved (CGI-I 1-3), * No Change (CGI-I 4), * Slightly Worse to Very Much Worse (CGI-I 5-7).
Secondary	Clinician Rated Clinical Global Impressions - Improvement	14 days	The CGI-I is a 7 point scale ranging from a score of 1 (very much improved) to 7 (very much worse), with no change in the middle, and assesses the improvement in relation to the baseline evaluation. Patients will be grouped according change in disease as follows; * Very Much Improved to Slightly Improved (CGI-I 1-3), * No Change (CGI-I 4), * Slightly Worse to Very Much Worse (CGI-I 5-7).

Source ClinicalTrials.gov

Outcomes9

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in Orthostatic Hypotension Questionnaire Composite Score (OHQ)	14 days	The analysis population was based on the ITT population of all patients randomized. Last observation carry forward was used for patients who prematurely discontinued the study.~One droxidopa patient was excluded from the analysis because OHQ values were not evaluable.	units on a scale	MEAN
SECONDARY	Change in Orthostatic Hypotension Daily Activities (OHDAS) Score	14 days	One droxidopa patient excluded from analysis because data were not evaluable.	units on a scale	MEAN
SECONDARY	Change in Orthostatic Hypotension Symptom Assessment (OHSA) Composite Score	14 days		units on a scale	MEAN
SECONDARY	Change in Systolic Blood Pressure (SBP) Measurements 3 Minutes Post Standing	14 days		mmHg	MEAN
POST_HOC	Change in Dizziness/ Lightheadedness/ Feeling Faint/ or Feeling Like You Might Blackout (OHSA Item 1)	14 days		units on a scale	MEAN
SECONDARY	Patient Reported Clinical Global Impression - Severity	14 days		participants	NUMBER
SECONDARY	Clinician Recorded Clinical Global Impression - Severity	14 days		participants	NUMBER
SECONDARY	Patient Reported Clinical Global Impression - Improvement	14 days		participants	NUMBER
SECONDARY	Clinician Rated Clinical Global Impressions - Improvement	14 days		participants	NUMBER

Source ClinicalTrials.gov

Results by group34

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

Outcome	Group	Value	Spread	Units
Change in Orthostatic Hypotension Questionnaire Composite Score (OHQ)	Droxidopa	0.57	Standard Deviation 1.891	units on a scale
Change in Orthostatic Hypotension Questionnaire Composite Score (OHQ)	Placebo	0.90	Standard Deviation 1.550	units on a scale
Change in Orthostatic Hypotension Daily Activities (OHDAS) Score	Droxidopa	0.53	Standard Deviation 2.204	units on a scale
Change in Orthostatic Hypotension Daily Activities (OHDAS) Score	Placebo	0.71	Standard Deviation 1.629	units on a scale
Change in Orthostatic Hypotension Symptom Assessment (OHSA) Composite Score	Droxidopa	0.59	Standard Deviation 1.963	units on a scale
Change in Orthostatic Hypotension Symptom Assessment (OHSA) Composite Score	Placebo	1.10	Standard Deviation 1.658	units on a scale
Change in Systolic Blood Pressure (SBP) Measurements 3 Minutes Post Standing	Droxidopa	-8.4	Standard Deviation 26.63	mmHg
Change in Systolic Blood Pressure (SBP) Measurements 3 Minutes Post Standing	Placebo	0.0	Standard Deviation 18.51	mmHg
Change in Dizziness/ Lightheadedness/ Feeling Faint/ or Feeling Like You Might Blackout (OHSA Item 1)	Droxidopa	0.9	Standard Deviation 2.39	units on a scale
Change in Dizziness/ Lightheadedness/ Feeling Faint/ or Feeling Like You Might Blackout (OHSA Item 1)	Placebo	1.3	Standard Deviation 2.21	units on a scale

1 to 10 of 34Source ClinicalTrials.gov

See all 34 results by group

Participant flow27

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

Period	Milestone	Group	Participants
Open Label Treatment	STARTED	Open-Label Droxidopa	103
Open Label Treatment	STARTED	Double-blind Droxidopa	0
Open Label Treatment	STARTED	Double-blind Placebo	0
Open Label Treatment	COMPLETED	Open-Label Droxidopa	75
Open Label Treatment	COMPLETED	Double-blind Droxidopa	0
Open Label Treatment	COMPLETED	Double-blind Placebo	0
Open Label Treatment	NOT COMPLETED	Open-Label Droxidopa	28
Open Label Treatment	NOT COMPLETED	Double-blind Droxidopa	0
Open Label Treatment	NOT COMPLETED	Double-blind Placebo	0
2 Week Randomized Withdrawal	STARTED	Open-Label Droxidopa	0

1 to 10 of 27Source ClinicalTrials.gov

See all 27 participant flow

Adverse events265

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	Three Month Open-Label Droxidopa	5	102	6
other	Headache	Nervous system disorders	Double-blind Droxidopa	1	38	1
other	Headache	Nervous system disorders	Double-blind Placebo	2	37	2
other	Headache	Nervous system disorders	Long-Term Follow-up	6	74	6
other	Headache	Nervous system disorders	Total Droxidopa	13	102	15
other	Syncope	Nervous system disorders	Three Month Open-Label Droxidopa	4	102	5
other	Syncope	Nervous system disorders	Double-blind Droxidopa	1	38	2
other	Syncope	Nervous system disorders	Double-blind Placebo	0	37	0
other	Syncope	Nervous system disorders	Long-Term Follow-up	7	74	9
other	Syncope	Nervous system disorders	Total Droxidopa	10	102	17

1 to 10 of 265Source ClinicalTrials.gov

See all 265 adverse events

Adverse event totals15

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Three Month Open-Label Droxidopa
Total, all-cause mortality	Double-blind Droxidopa
Total, all-cause mortality	Double-blind Placebo
Total, all-cause mortality	Long-Term Follow-up
Total, all-cause mortality	Total Droxidopa
Total, other adverse events	Three Month Open-Label Droxidopa	37	102
Total, other adverse events	Double-blind Droxidopa	8	38
Total, other adverse events	Double-blind Placebo	4	37
Total, other adverse events	Long-Term Follow-up	43	74
Total, other adverse events	Total Droxidopa	62	102

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse event totals

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.

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