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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: Completed Phase 1 study, sponsored by William Ondo, MD.
NCT03218969 is a Phase 1 study that has completed, run by William Ondo, MD. The registered enrollment target is 10 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
IRLS scale is a patient-administered test that measures the severity of restless legs syndrome symptoms. The IRLS scale consists of 10 questions rated from 0 to 4. The total score on symptom severity range from 0 (none) to 40 (worst).
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 |
What the finished NCT03218969 record still lists
NCT03218969 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03218969 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03218969's enrollment target sits among peer trials
10 1913th of 2000 higher than 46 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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