Trial · NCT01176240
A Two Part Study (306A/306B) to Assess Droxidopa in Treatment of NOH in Patients With Parkinson's Disease
NCT01176240, Phase 3, Completed, Chelsea Therapeutics; results first posted 2014-05-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Two Part Study (306A/306B) to Assess Droxidopa in Treatment of NOH in Patients With Parkinson's Disease. Trials, record NCT01176240. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01176240
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Two Part Study (306A/306B) to Assess Droxidopa in Treatment of NOH in Patients With Parkinson's Disease
- NCT number
- NCT01176240
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 225 participants, actual
- Lead sponsor
- Chelsea Therapeutics
- Conditions
- Orthostatic Hypotension, Parkinson's Disease
- Interventions
- Droxidopa, Placebo
- First posted
- 2010-08-05
- Last updated
- 2014-05-20
- Results first posted
- 2014-05-20
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 306A Efficacy: Change in Orthostatic Hypotension Questionnaire Score (OHQ) | Baseline, Week 8 | The primary efficacy endpoint for 306A is the relative mean change in Orthostatic Hypotension Questionnaire (OHQ) composite score from baseline to end of study. 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. For the change from baseline, negative numbers represent improvement from baseline in OHQ score. |
| Primary | 306B Efficacy: Change in Dizziness/Lightheadedness/Feeling Faint/Feeling Like You Might Black Out (OHSA Item 1) | Baseline, Week1 | OHSA item 1 scale range: 0 (none) -10 (worst), likert scale. Change: score at Week 1 minus score at baseline. A negative score indicates an improvement in symptoms during the double-blind randomized phase relative to value at baseline. |
| Secondary | 306B Efficacy: Change in OHSA Item 1 From Baseline to Week 2 (Visit 5) | Baseline, Week2 | OHSA item 1 scale range: 0 (none) -10 (worst), likert scale. Change: score at Week 2 minus score at baseline. A negative score indicates an improvement in symptoms during the double-blind randomized phase relative to value at baseline. |
| Secondary | 306B Efficacy: Change in OHSA Item 1 From Baseline to Week 4 (Visit 6) | Baseline, Week4 | OHSA item 1 scale range: 0 (none) -10 (worst), likert scale. Change: score at Week 4 minus score at baseline. A negative score indicates an improvement in symptoms during the double-blind randomized phase relative to value at baseline. |
| Secondary | 306B Efficacy: Change in Systolic Blood Pressure (SBP) Measurements Post Standing From Baseline to Week 1 | Baseline, Week 1 | Measure: Lowest standing systolic blood pressure reading of immediately post standing and 3 minutes post standing. Change: standing systolic blood pressure at Week 1 (Visit 4) minus standing systolic blood pressure at baseline. A positive score indicates an improvement in standing systolic blood pressure during the double-blind randomized phase relative to value at baseline. |
| Secondary | 306B Efficacy: Change in OHSA Item 1 From Baseline to Week 8 (Visit 7) | Baseline, Week 8 | OHSA item 1 scale range: 0 (none) -10 (worst), likert scale. Change: score at Week 8 minus score at baseline. A negative score indicates an improvement in symptoms during the double-blind randomized phase relative to value at baseline. |
| Secondary | 306B Efficacy: Rate of Patient Reported Falls | up to 10 weeks | The average number of patient reported falls per week. |
| Secondary | 306B Efficacy: Change in Orthostatic Hypotension Questionnaire Score (OHQ) | Baseline, Week 8 | The relative mean change in Orthostatic Hypotension Questionnaire (OHQ) composite score from baseline to end of study. 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. For the change from baseline, negative numbers represent improvement from baseline in OHQ score. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 306A Efficacy: Change in Orthostatic Hypotension Questionnaire Score (OHQ) | Baseline, Week 8 | LOCF was used to impute values for patients who did not have an end of study visit. | units on a scale | MEAN |
| PRIMARY | 306B Efficacy: Change in Dizziness/Lightheadedness/Feeling Faint/Feeling Like You Might Black Out (OHSA Item 1) | Baseline, Week1 | The primary analysis was defined as those patients who completed 1 week of dosing at the identified optimal dose of study medication and completed the visit 4 (1 week) efficacy evaluation. Patients who did not have week 1 efficacy data were excluded from the analysis. | units on a scale | MEAN |
| POST_HOC | 306A Efficacy: Patient Reported Falls | Baseline, Week 8 | total falls per group | NUMBER | |
| SECONDARY | 306B Efficacy: Change in OHSA Item 1 From Baseline to Week 2 (Visit 5) | Baseline, Week2 | units on a scale | MEAN | |
| SECONDARY | 306B Efficacy: Change in OHSA Item 1 From Baseline to Week 4 (Visit 6) | Baseline, Week4 | units on a scale | MEAN | |
| SECONDARY | 306B Efficacy: Change in Systolic Blood Pressure (SBP) Measurements Post Standing From Baseline to Week 1 | Baseline, Week 1 | One droxidopa patient did not complete the standing blood pressure measurements of the orthostatic standing test at visit 4 (one week of stable dosing) | mmHg | MEAN |
| SECONDARY | 306B Efficacy: Change in OHSA Item 1 From Baseline to Week 8 (Visit 7) | Baseline, Week 8 | The analysis was defined as those patients who completed 8 week of dosing and completed the visit 7 (8 week) efficacy evaluation. Patients who did not have week 8 efficacy data were excluded from the analysis. Of note, 2 patients completed the 8 week double blind study, but did not complete the efficacy evaluations at the final visit. | units on a scale | MEAN |
| SECONDARY | 306B Efficacy: Rate of Patient Reported Falls | up to 10 weeks | The primary analysis was defined as those patients who completed 1 week of dosing at the identified optimal dose of study medication and completed the visit 4 (1 week) efficacy evaluation. Patients who did not have week 1 efficacy data were excluded from the analysis. | falls per week | MEAN |
| SECONDARY | 306B Efficacy: Change in Orthostatic Hypotension Questionnaire Score (OHQ) | Baseline, Week 8 | The primary analysis was defined as those patients who completed 8 week of dosing and completed the visit 7 (8 week) efficacy evaluation. Patients who did not have week 8 efficacy data were excluded from the analysis. Of note, 2 patients completed the 8 week double blind study, but did not complete the efficacy evaluations at the final visit. | units on a scale | MEAN |
| POST_HOC | Study 306A: Change in Dizziness/Lightheadedness/Feeling Faint/Feeling Like You Might Black Out (OHSA Item 1) From Baseline to Week 1 | Baseline, Week 1 | Last observation carried forward was used to impute missing values. | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 306A Efficacy: Change in Orthostatic Hypotension Questionnaire Score (OHQ) | Droxidopa | -2.2 | Standard Deviation 2.44 | units on a scale | |
| 306A Efficacy: Change in Orthostatic Hypotension Questionnaire Score (OHQ) | Placebo | -2.1 | Standard Deviation 2.49 | units on a scale | |
| 306B Efficacy: Change in Dizziness/Lightheadedness/Feeling Faint/Feeling Like You Might Black Out (OHSA Item 1) | Droxidopa | -2.3 | Standard Deviation 2.95 | units on a scale | |
| 306B Efficacy: Change in Dizziness/Lightheadedness/Feeling Faint/Feeling Like You Might Black Out (OHSA Item 1) | Placebo | -1.3 | Standard Deviation 3.16 | units on a scale | |
| 306A Efficacy: Patient Reported Falls | Droxidopa | 79 | total falls per group | ||
| 306A Efficacy: Patient Reported Falls | Placebo | 192 | total falls per group | ||
| 306B Efficacy: Change in OHSA Item 1 From Baseline to Week 2 (Visit 5) | Droxidopa | -1.9 | Standard Deviation 2.86 | units on a scale | |
| 306B Efficacy: Change in OHSA Item 1 From Baseline to Week 2 (Visit 5) | Placebo | -1.6 | Standard Deviation 2.97 | units on a scale | |
| 306B Efficacy: Change in OHSA Item 1 From Baseline to Week 4 (Visit 6) | Droxidopa | -2.0 | Standard Deviation 3.08 | units on a scale | |
| 306B Efficacy: Change in OHSA Item 1 From Baseline to Week 4 (Visit 6) | Placebo | -1.5 | Standard Deviation 2.74 | units on a scale |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow20
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Study 306A | STARTED | Droxidopa | 24 | |
| Study 306A | STARTED | Placebo | 27 | |
| Study 306A | COMPLETED | Droxidopa | 21 | |
| Study 306A | COMPLETED | Placebo | 24 | |
| Study 306A | NOT COMPLETED | Droxidopa | 3 | |
| Study 306A | NOT COMPLETED | Placebo | 3 | |
| Study 306B | STARTED | Droxidopa | 89 | |
| Study 306B | STARTED | Placebo | 85 | |
| Study 306B | Took at Least 1 Dose of Study Drug | Droxidopa | 87 | |
| Study 306B | Took at Least 1 Dose of Study Drug | Placebo | 84 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 participant flowAdverse 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 | Droxidopa | 15 | 114 | 19 |
| other | Headache | Nervous system disorders | Placebo | 8 | 108 | 8 |
| other | Dizziness | Nervous system disorders | Droxidopa | 11 | 114 | 13 |
| other | Dizziness | Nervous system disorders | Placebo | 5 | 108 | 6 |
| other | Nausea | Gastrointestinal disorders | Droxidopa | 10 | 114 | 13 |
| other | Nausea | Gastrointestinal disorders | Placebo | 5 | 108 | 5 |
| other | Diarrhoea | Gastrointestinal disorders | Droxidopa | 4 | 114 | 4 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 8 | 108 | 9 |
| other | Fatigue | General disorders | Droxidopa | 8 | 114 | 8 |
| other | Fatigue | General disorders | Placebo | 6 | 108 | 7 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Droxidopa | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Droxidopa | 54 | 114 |
| Total, other adverse events | Placebo | 52 | 108 |
| Total, serious adverse events | Droxidopa | 5 | 114 |
| Total, serious adverse events | Placebo | 4 | 108 |
Source ClinicalTrials.gov
Papers10
The papers the trial lists on ClinicalTrials.gov.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Droxidopa vs Placebo: serious adverse events |
Source Trial comparisons
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.
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/NCT01176240
GET https://conductscience.org/api/trials/v1/NCT01176240/events?page=2