Treatment of Restless Leg Syndrome (RLS) Augmentation With Ecopipam, a D1 Specific Antagonist (RLS-Ecopipam)
Sponsor: Restless Legs Syndrome Foundation
Listed as NCT03218969, this observational or N/A phase trial focuses on Augmentation and Restless Legs Syndrome and remains completed. Sponsored by Restless Legs Syndrome Foundation, it has been updated 9 times since 2017, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.
Study Description(click to expand)This is a double-blind, exploratory proof of concept, cross-over trial of the D1 antagonist ecopipam for subjects with augmented Restless legs syndrome (RLS). Investigators will recruit 10 subjects taking dopamine agonists for RLS who are currently experiencing augmentation. The goal is to have 8 completers. There is no power analysis as this is an exploratory study and there is no previous data on treatment of augmentation. "Meaningful improvement" is not even established. A safety analysis will be done after 5 subjects have been enrolled. Duration of study and is based mostly on contracted drug availability for this pilot study.
This is a double-blind, exploratory proof of concept, cross-over trial of the D1 antagonist ecopipam for subjects with augmented Restless legs syndrome (RLS). Investigators will recruit 10 subjects taking dopamine agonists for RLS who are currently experiencing augmentation. The goal is to have 8 completers. There is no power analysis as this is an exploratory study and there is no previous data on treatment of augmentation. "Meaningful improvement" is not even established. A safety analysis will be done after 5 subjects have been enrolled. Duration of study and is based mostly on contracted drug availability for this pilot study.
Status Flow
Change History
9 versions recorded-
Apr 28, 2026 — Present [daily]
Completed
Status: Unknown → Completed · Phase: PHASE1/PHASE2 → None
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Sep 2024 — Apr 2026 [monthly]
Unknown PHASE1/PHASE2
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Jul 2024 — Sep 2024 [monthly]
Unknown PHASE1/PHASE2
Status: Unknown Status → Unknown · Phase: PHASE1_PHASE2 → PHASE1/PHASE2
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Oct 2021 — Jul 2024 [monthly]
Unknown Status PHASE1_PHASE2
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Jan 2021 — Oct 2021 [monthly]
Unknown Status PHASE1_PHASE2
▶ Show 4 earlier versions
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Aug 2020 — Jan 2021 [monthly]
Unknown Status PHASE1_PHASE2
Status: Active Not Recruiting → Unknown Status
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Aug 2018 — Aug 2020 [monthly]
Active Not Recruiting PHASE1_PHASE2
Status: Not Yet Recruiting → Active Not Recruiting
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Jun 2018 — Aug 2018 [monthly]
Not Yet Recruiting PHASE1_PHASE2
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Aug 2017 — Jun 2018 [monthly]
Not Yet Recruiting PHASE1_PHASE2
First recorded
Eligibility 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.
Contact Information
- Restless Legs Syndrome Foundation
- William Ondo, MD
For direct contact, visit the study record on ClinicalTrials.gov .