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

• Status: Unknown status
• Trial end date: 2018-10-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: William Ondo, MD
• Collaborator: Restless Legs Syndrome Foundation
• Treatments: Ecopipam

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