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

Restless Legs Syndrome Clinical Trial

— RLS-Ecopipam  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03218969
• Other study ID #: Pro#00016705
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: September 18, 2017
• Est. completion date: October 15, 2018

Study information

• Verified date: July 2018
• Source: The Methodist Hospital System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: October 15, 2018
• Est. primary completion date: September 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Augmentation
• Psychomotor Agitation
• Restless Legs Syndrome
• Syndrome

Intervention

Drug:
• Ecopipam
oral drug in subjection currently experiencing dopamine agonist induced augmentation
• Placebo
matching placebo

Locations

Country	Name	City	State
United States	Houston Methodist Hospital	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
William Ondo, MD	Restless Legs Syndrome Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hamilton depresion scale	scale	baseline to end of each treatment arm (6 weeks)
Other	MOS sleep scale	scale	baseline to end of each treatment arm (6 weeks)
Other	Fatigue severity scale	scale	baseline to end of each treatment arm (6 weeks)
Other	Columbia Suicide Severity Rating Scale	scale	baseline to end of each treatment arm (6 weeks)
Other	Epworth sleep scale	scale	baseline to end of each treatment arm (6 weeks)
Other	Serum chemistry (liver enzymes ALT and AST)	safety assessment	baseline to end of each treatment arm (6 weeks)
Other	Vital signs	safety assessment	baseline to end of each treatment arm (6 weeks)
Other	Physical/Neurological exam	safety assessment	baseline to end of each treatment arm (6 weeks)
Other	12 lead ECG	safety assessment	baseline to end of each treatment arm (6 weeks)
Primary	International RLS Rating scale	scale	baseline to end of each treatment arm (6 weeks)
Primary	Augmentation severity scale	scale	baseline to end of each treatment arm (6 weeks)
Secondary	24 hour RLS diary	diary of RLS symptoms	Day 0 (visit 1) to end of each treatment arm (6 weeks)
Secondary	Clinical Global Impression	scale	From start of each treatment arm through one week after treatment withdrawal