Phase 2
N=10
Treatment of Restless Leg Syndrome (RLS) Augmentation With Ecopipam, a D1 Specific Antagonist
Restless Legs Syndrome · Augmentation
Bottom Line
View on ClinicalTrials.gov: NCT03218969 ↗Enrolled (actual)
10
Serious AEs
5.3%
Results posted
Apr 2026
Primary outcome: Primary: Change From Baseline (Predose) in Mean International Restless Legs Syndrome (IRLS) Rating Scale at End of Intervention Period — 20.6; 21.6; 16; 18.8 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Ecopipam (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- William Ondo, MD
- Primary completion
- Sep 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline (Predose) in Mean International Restless Legs Syndrome (IRLS) Rating Scale at End of Intervention Period |
20.6; 21.6; 16; 18.8 | — |
| PRIMARY Change From Baseline in Mean Body Part Affected by RLS Symptoms Using Augmentation Severity Rating Scale (ASRS) |
3.1; 2.44; 2.9; 2.33 | — |
| SECONDARY Mean 24 Hour Restless Legs Syndrome (RLS) Diary at End of Intervention |
10.2; 15 | — |
| SECONDARY Number of Participants With Effect on the Clinical Global Impression Scale at the End of the Intervention |
3; 0; 1; 2; 3; 2 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Provide consent to participate in the study
- Individuals of either sex, 21-80 years of age
- Clinically defined Restless Leg Syndrome, and problematic augmentation currently on monotherapy with dopaminergic treatment.
Exclusion Criteria
- Current use of Opioid medications
- Clinical relevant depression or other medical problems that in the opinion of the investigator would not allow for safe completion of the protocol.
- Suicidal ideation
- History of epilepsy
- Current MAO inhibitors
Data sourced from ClinicalTrials.gov (NCT03218969). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.