CompletedPhase 1/2

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

United States10 participantsStarted 2017-09-18

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

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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

What they're measuring

Change From Baseline (Predose) in Mean International Restless Legs Syndrome (IRLS) Rating Scale at End of Intervention Period

Timeframe: Baseline (Pre-intervention), and at 5 weeks

Change From Baseline in Mean Body Part Affected by RLS Symptoms Using Augmentation Severity Rating Scale (ASRS)

Timeframe: Baseline (Pre-intervention), and at 5 weeks

Trial details

NCT IDNCT03218969

SponsorWilliam Ondo, MD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-09-28

Results submitted2019-08-28

View on ClinicalTrials.gov More Restless Legs Syndrome trials