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

William Ondo, MD

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Augmentation; Restless Legs Syndrome

Treatments: Drug: Placebo; Drug: Ecopipam

Study type: Interventional

Funder types: Other

Identifiers

NCT03218969

Pro#00016705

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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10 participants in 2 patient groups

Study period 1

Experimental group

Description:

* Ecopipam or matching placebo 25 mg by mouth for 7 days (week 1), followed by * Ecopipam or matching placebo 50 mg by mouth for 7 days (week 2), followed by * Ecopipam or matching placebo 100 mg by mouth for 23 days (weeks 3).

Treatment:

Drug: Ecopipam

Drug: Placebo

Study period 2

Experimental group

Description:

* Matching placebo or ecopipam 25 mg by mouth for 7 days (week 7), followed by * Matching placebo or ecopipam 50 mg by mouth for 7 days (week 8), followed by * Matching placebo or ecopipam 100 mg by mouth for 23 days (week 9).

Treatment:

Drug: Ecopipam

Drug: Placebo