At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 10 enrolled

Drug / intervention

Ecopipam +1 moredrug

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03218969

NCT03218969Phase 2Completed

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Treatment of Restless Leg Syndrome (RLS) Augmentation With Ecopipam, a D1 Specific Antagonist

William Ondo, MD·interventional·Posted Jul 17, 2017·Updated Apr 27, 2026

In Brief

A Phase 2 clinical trial evaluating Ecopipam and Placebo for Restless Legs Syndrome and Augmentation. Completed, enrolled 10 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsRestless Legs Syndrome, Augmentation

CountriesUnited States

CollaboratorsRestless Legs Syndrome Foundation

Timeline

Phase 2CompletedFinished

201820192020202120222023202420252026

First PostedJul 2017

Enrollment StartSep 2017

Primary CompletionSep 2018

Study CompletionNov 2018

TodayJul 2026

First PostedJul 17, 2017

Enrollment StartSep 18, 2017

Primary CompletionSep 28, 2018

Study CompletionNov 28, 2018

TodayJul 2, 2026

Enrollment to primary: 1.0 yearsPosted 9.0 years ago

Interventions

Ecopipamdrug

oral drug in subjection currently experiencing dopamine agonist induced augmentation

Placebodrug

matching placebo