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NCT03218969 · ClinicalTrials.gov registry record · Phase 1
Treatment of Restless Leg Syndrome (RLS) Augmentation With Ecopipam, a D1 Specific Antagonist
A Phase 1 study, sponsored by William Ondo, MD.
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT03218969 is a Phase 1 study that has completed, run by William Ondo, MD. The registered enrollment target is 10 participants.
The verdict
NCT03218969, a Phase 1 study, has completed, sponsored by William Ondo, MD.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
This is an exploratory, double blinded cross-over study of the D1 antagonist ecopipam treat patients currently having dopamine agonist induced augmentation in restless legs syndrome. Each arm is 6 weeks composed of an unforced titration up to 100mg/day separated by a 2-week wash-out period. Efficacy points will include the IRLS, augmentation scales, sleep scales, clinical impressions and fatigue/mood scales.
Interventions
- DRUG Placebo
- DRUG Ecopipam
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2017-09-18 |
| Est. Completion | 2018-11-28 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03218969
The ClinicalTrials.gov registry entry for NCT03218969 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is William Ondo, MD, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03218969 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03218969 about?
NCT03218969 is a clinical study titled "Treatment of Restless Leg Syndrome (RLS) Augmentation With Ecopipam, a D1 Specific Antagonist". This is an exploratory, double blinded cross-over study of the D1 antagonist ecopipam treat patients currently having dopamine agonist induced augmentation in restless legs syndrome. Each arm is 6 weeks composed of an unforced titration up to 100mg/day separated by a 2-week wash-out period. Efficacy...
What is the current status of trial NCT03218969?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2017-09-18. Estimated completion is 2018-11-28.
What interventions are being tested in trial NCT03218969?
The interventions under investigation include: Placebo (DRUG), Ecopipam (DRUG).
Who is sponsoring clinical trial NCT03218969?
This trial is sponsored by William Ondo, MD, which has 2 total clinical trials registered on ClinicalTrials.gov.
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