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NCT03034564 · ClinicalTrials.gov registry record · Phase 4
A Randomized, Double-Blind, Placebo-Controlled Study of Droxidopa for Fatigue in Parkinson's Disease
A Phase 4 study, sponsored by The Cooper Health System.
- Terminated
- Registry status
- Phase 4
- Development phase
- 1
- Enrollment target
NCT03034564 is a Phase 4 study that was terminated before completion, run by The Cooper Health System. The registered enrollment target is 1 participants.
The verdict
NCT03034564, a Phase 4 study, was terminated before completion, sponsored by The Cooper Health System.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 1 participants
- Enrollment target
Study Summary
This is a randomized, double-blind, placebo-controlled trial comparing droxidopa to placebo for fatigue in Parkinson's Disease. The primary outcome measure is change in the Parkinson's Disease Fatigue Scale, a 16-item scale that measures the physical effects of fatigue as well as the impact of fatigue on daily functioning and activities, including socialization. Secondary outcomes are the PDQ-39, a 39-item self-report questionnaire assessing Parkinson's disease-specific health related quality over the last month in 8 different dimensions of function and well-being, and the Epworth Sleepiness Scale, a questionnaire querying 8 situations for which the subject will rate the likelihood of falling asleep. There will be a screening visit (SC), baseline visit (BL), 2 clinic visits at 6 and 12 weeks (V01, V02), and telephone contact at 4 weeks and 8 weeks (T1, T2). In-person visits will include review of informed consent, concomitant medication review, adverse event review, pill counts, vital signs (including supine blood pressure), and outcome measurements. Telephone visits will include review of informed consent, concomitant medication review, and adverse event review.
Interventions
- DRUG Placebo Oral Tablet
- DRUG Northera
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2017-01 |
| Est. Completion | 2018-09-30 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03034564
The ClinicalTrials.gov registry entry for NCT03034564 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The Cooper Health System, which has 39 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo Oral Tablet is the first listed.
NCT03034564 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03034564 about?
NCT03034564 is a clinical study titled "A Randomized, Double-Blind, Placebo-Controlled Study of Droxidopa for Fatigue in Parkinson's Disease". This is a randomized, double-blind, placebo-controlled trial comparing droxidopa to placebo for fatigue in Parkinson's Disease. The primary outcome measure is change in the Parkinson's Disease Fatigue Scale, a 16-item scale that measures the physical effects of fatigue as well as the impact of fatig...
What is the current status of trial NCT03034564?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 1 participants. The study started on 2017-01. Estimated completion is 2018-09-30.
What interventions are being tested in trial NCT03034564?
The interventions under investigation include: Placebo Oral Tablet (DRUG), Northera (DRUG).
Who is sponsoring clinical trial NCT03034564?
This trial is sponsored by The Cooper Health System, which has 39 total clinical trials registered on ClinicalTrials.gov.
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