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

Phase 1

• Conditions: Restless Legs Syndrome; Augmentation
• Interventions: Drug: Ecopipam; Drug: Placebo

• Registration Number: NCT03218969
• Lead Sponsor: William Ondo, MD

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2017-04-21
• Study First Submitted QC: 2017-07-12
• Study First Posted: 2017-07-17
• Study Start: 2017-09-18
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-20
• Last Update Posted: 2018-07-24
• Primary Completion: 2018-09-15
• Study Completion: 2018-10-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Study period 1	Ecopipam	* 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).
Study period 1	Placebo	* 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).
Study period 2	Ecopipam	* 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).
Study period 2	Placebo	* 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).

Primary Outcome Measures

Name	Time	Method
Augmentation severity scale	baseline to end of each treatment arm (6 weeks)	scale
International RLS Rating scale	baseline to end of each treatment arm (6 weeks)	scale

Secondary Outcome Measures

Name	Time	Method
24 hour RLS diary	Day 0 (visit 1) to end of each treatment arm (6 weeks)	diary of RLS symptoms
Clinical Global Impression	From start of each treatment arm through one week after treatment withdrawal	scale

Trial Locations

Locations (1)

Houston Methodist Hospital; 🇺🇸 Houston, Texas, United States