Trial · NCT00633880

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

NCT00633880, Phase 3, Completed, Chelsea Therapeutics; results first posted 2014-05-20

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Clinical Study of Droxidopa in Patients With Neurogenic Orthostatic Hypotension (NOH). Trials, record NCT00633880. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00633880

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Trial

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

Title: Clinical Study of Droxidopa in Patients With Neurogenic Orthostatic Hypotension (NOH)
NCT number: NCT00633880
Status: Completed
Phases: Phase 3
Enrollment: 181 participants, actual
Lead sponsor: Chelsea Therapeutics
Conditions: Symptomatic Neurogenic Orthostatic Hypotension (NOH), Non-diabetic Neuropathy, Primary Autonomic Failure, Dopamine Beta Hydroxylase Deficiency
Interventions: Placebo, Droxidopa
First posted: 2008-03-12
Last updated: 2014-05-20
Results first posted: 2014-05-20

Source ClinicalTrials.gov

Registered outcomes10

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)	14 days	OHSA item 1 scale range: 0 (none) -10 (worst), likert scale. Change: score at end of study 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 Fatigue (OHSA Item 4)	14 days	OHSA item 4 scale range: 0 (none) -10 (worst), likert scale. Change: score at end of study 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 Weakness (OHSA Item 3)	14 days	OHSA item 3 scale range: 0 (none) -10 (worst), likert scale. Change: score at end of study 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 Vision (OHSA Item 2)	14 days	OHSA item 2 scale range: 0 (none) -10 (worst), likert scale. Change: score at end of study 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 Concentration (OHSA Item 5)	14 days	OHSA item 5 scale range: 0 (none) -10 (worst), likert scale. Change: score at end of study 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 Head/Neck Discomfort (OHSA Item 6)	14 days	OHSA item 6 scale range: 0 (none) -10 (worst), likert scale. Change: score at end of study 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 Ability to Conduct Activities of Daily Living Score (OHDAS Composite 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 study 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 Score (OHSA Composite)	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 study 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 Scores Excluding Dizziness (OHSA Composite Items 2-6)	14 days	OHSA composite scale (items 2-6) is the average of five OHSA items: 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 study 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) .

Source ClinicalTrials.gov

Outcomes11

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)	14 days	Missing data were imputed using the last observation carry forward method.	units on a scale	MEAN
SECONDARY	Change in Fatigue (OHSA Item 4)	14 days		units on a scale	MEAN
SECONDARY	Change in Weakness (OHSA Item 3)	14 days		units on a scale	MEAN
SECONDARY	Change in Vision (OHSA Item 2)	14 days		units on a scale	MEAN
SECONDARY	Change in Concentration (OHSA Item 5)	14 days		units on a scale	MEAN
POST_HOC	Change in Orthostatic Hypotension Questionnaire Score (OHQ)	14 days	3 droxidopa patients and 2 placebo patients were excluded from the analysis due to missing randomization values.	units on a scale	MEAN
SECONDARY	Change in Head/Neck Discomfort (OHSA Item 6)	14 days		units on a scale	MEAN
SECONDARY	Change in Ability to Conduct Activities of Daily Living Score (OHDAS Composite Score)	14 days	One placebo patient excluded from analysis because OHDAS values were not evaluable.	units on a scale	MEAN
SECONDARY	Change in Orthostatic Hypotension Symptom Assessment Score (OHSA Composite)	14 days		units on a scale	MEAN
SECONDARY	Change in Orthostatic Hypotension Symptom Scores Excluding Dizziness (OHSA Composite Items 2-6)	14 days	One placebo patient excluded from analysis per the SAP because all baseline values in the composite were zero.~LOCF was used to impute values for patients who did not have an end of study visit.	units on a scale	MEAN

1 to 10 of 11Source ClinicalTrials.gov

See all 11 outcomes

Results by group22

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

Outcome	Group	Value	Spread	Units
Change in Dizziness/ Lightheadedness/ Feeling Faint/ or Feeling Like You Might Blackout (OHSA Item 1)	Droxidopa	1.3	Standard Deviation 2.75	units on a scale
Change in Dizziness/ Lightheadedness/ Feeling Faint/ or Feeling Like You Might Blackout (OHSA Item 1)	Placebo	1.9	Standard Deviation 3.16	units on a scale
Change in Fatigue (OHSA Item 4)	Droxidopa	0.7	Standard Deviation 2.61	units on a scale
Change in Fatigue (OHSA Item 4)	Placebo	1.5	Standard Deviation 2.72	units on a scale
Change in Weakness (OHSA Item 3)	Droxidopa	0.3	Standard Deviation 2.88	units on a scale
Change in Weakness (OHSA Item 3)	Placebo	1.2	Standard Deviation 2.70	units on a scale
Change in Vision (OHSA Item 2)	Droxidopa	1.1	Standard Deviation 2.79	units on a scale
Change in Vision (OHSA Item 2)	Placebo	0.8	Standard Deviation 2.24	units on a scale
Change in Concentration (OHSA Item 5)	Droxidopa	0.1	Standard Deviation 2.74	units on a scale
Change in Concentration (OHSA Item 5)	Placebo	0.9	Standard Deviation 2.67	units on a scale

1 to 10 of 22Source ClinicalTrials.gov

See all 22 results by group

Participant flow18

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

Period	Milestone	Group	Participants
Open Label Titration	STARTED	Open Label Titration	181
Open Label Titration	STARTED	Droxidopa	0
Open Label Titration	STARTED	Placebo	0
Open Label Titration	COMPLETED	Open Label Titration	101
Open Label Titration	COMPLETED	Droxidopa	0
Open Label Titration	COMPLETED	Placebo	0
Open Label Titration	NOT COMPLETED	Open Label Titration	80
Open Label Titration	NOT COMPLETED	Droxidopa	0
Open Label Titration	NOT COMPLETED	Placebo	0
Randomized Double Blind	STARTED	Open Label Titration	0

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events33

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	Droxidopa	2	50	2
other	Headache	Nervous system disorders	Placebo	4	51	4
other	Headache	Nervous system disorders	Open Label Phase	20	181	28
other	Dizziness	Nervous system disorders	Droxidopa	2	50	2
other	Dizziness	Nervous system disorders	Placebo	1	51	1
other	Dizziness	Nervous system disorders	Open Label Phase	15	181	18
other	Fatigue	General disorders	Droxidopa	0	50	0
other	Fatigue	General disorders	Placebo	1	51	1
other	Fatigue	General disorders	Open Label Phase	10	181	10
other	Fall	Injury, poisoning and procedural complications	Droxidopa	1	50	2

1 to 10 of 33Source ClinicalTrials.gov

See all 33 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Droxidopa
Total, all-cause mortality	Placebo
Total, all-cause mortality	Open Label Phase
Total, other adverse events	Droxidopa	4	50
Total, other adverse events	Placebo	11	51
Total, other adverse events	Open Label Phase	44	181
Total, serious adverse events	Droxidopa	0	50
Total, serious adverse events	Placebo	1	51
Total, serious adverse events	Open Label Phase	4	181

Source ClinicalTrials.gov

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
25350981	DERIVED	PubMed
27538531	DERIVED	PubMed
28494751	DERIVED	PubMed

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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Read this trial from software.

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