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NCT01176240 · ClinicalTrials.gov registry record · Phase 3
A Two Part Study (306A/306B) to Assess Droxidopa in Treatment of NOH in Patients With Parkinson's Disease
A Phase 3 study, sponsored by Chelsea Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 225
- Enrollment target
NCT01176240: Completed Phase 3 study, sponsored by Chelsea Therapeutics.
NCT01176240 is a Phase 3 study that has completed, run by Chelsea Therapeutics. The registered enrollment target is 225 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01176240, a Phase 3 study, has completed, sponsored by Chelsea Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 225 participants
- Enrollment target
Study Summary
This is a study to evaluate the effects of an investigational drug, Droxidopa, in participants with neurogenic orthostatic hypotension (NOH), associated with Parkinson's disease. Droxidopa is being studied to determine the effects on blood pressure changes upon standing up (orthostatic challenge). Symptoms and activity measurements, including patient reported falls, will be evaluated to determine the effectiveness of the study drug. Symptoms of NOH may include any of the following: * Dizziness, light-headedness, feeling faint or feeling like you may blackout * Problems with vision (blurring, seeing spots, tunnel vision, etc.) * Weakness * Fatigue * Trouble concentrating * Head \& neck discomfort (the coat hanger syndrome) * Difficulty standing for a short time or a long time * Trouble walking for a short time or a long time The study duration is a maximum of approximately 14 weeks including up to 2 weeks for screening, up to 2 weeks for proper dose finding, followed by an 8 week treatment period and a follow-up visit after 2 weeks. A sufficient number of patients will be screened to allow approximately 211 randomized patients. An extension study is also available to continue treatment if determined appropriate by the study doctor. This Study is NCT01132326 sponsored by Chelsea Therapeutics and is enrolling by invitation only.
Primary Outcome
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 fai
Interventions
- OTHER Placebo
- DRUG Droxidopa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 225 participants |
| Start Date | 2010-06 |
| Est. Completion | 2012-11 |
| Phase | Phase 3 |
What the finished NCT01176240 record still lists
NCT01176240 is an interventional study that assigns participants to a tested intervention. The registered 225 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (71% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01176240 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01176240 about?
NCT01176240 is a clinical study titled "A Two Part Study (306A/306B) to Assess Droxidopa in Treatment of NOH in Patients With Parkinson's Disease". This is a study to evaluate the effects of an investigational drug, Droxidopa, in participants with neurogenic orthostatic hypotension (NOH), associated with Parkinson's disease. Droxidopa is being studied to determine the effects on blood pressure changes upon standing up (orthostatic challenge). S...
What is the current status of trial NCT01176240?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 225 participants. The study started on 2010-06. Estimated completion is 2012-11.
What interventions are being tested in trial NCT01176240?
The interventions under investigation include: Placebo (OTHER), Droxidopa (DRUG).
Who is sponsoring clinical trial NCT01176240?
This trial is sponsored by Chelsea Therapeutics, which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01176240's enrollment target sits among peer trials
225 1311th of 2000 higher than 684 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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