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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 is a Phase 3 study that has completed, run by Chelsea Therapeutics. The registered enrollment target is 225 participants.
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.
Interventions
- OTHER Placebo
- DRUG Droxidopa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 225 participants |
| Start Date | 2010-06 |
| Est. Completion | 2012-11 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01176240
The ClinicalTrials.gov registry entry for NCT01176240 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 225 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Chelsea Therapeutics, which has 10 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01176240 reports 0 study locations.
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.
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