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

NCT ID: NCT03218969

Last Updated: 2018-07-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-18
• Study Completion Date: 2018-10-15

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.

Conditions

Restless Legs Syndrome; Augmentation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Study period 1

• 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).

Group Type: EXPERIMENTAL

Ecopipam

Intervention Type: DRUG

oral drug in subjection currently experiencing dopamine agonist induced augmentation

Placebo

Intervention Type: DRUG

matching placebo

Study period 2

• 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).

Group Type: EXPERIMENTAL

Ecopipam

Intervention Type: DRUG

oral drug in subjection currently experiencing dopamine agonist induced augmentation

Placebo

Intervention Type: DRUG

matching placebo

Interventions

Ecopipam

oral drug in subjection currently experiencing dopamine agonist induced augmentation

Intervention Type: DRUG

Placebo

matching placebo

Intervention Type: DRUG

Other Intervention Names

PSYRX101

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Restless Legs Syndrome Foundation

UNKNOWN

Sponsor Role: collaborator

William Ondo, MD

OTHER

Sponsor Role: lead

Responsible Party

William Ondo, MD

HMRI Principal & Sponsor Investigator: Ondo

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

William G. Ondo, MD

Role: PRINCIPAL_INVESTIGATOR

The Methodist Hospital Research Institute

Locations

Houston Methodist Hospital

Houston, Texas, United States

Countries

United States

Other Identifiers

Pro#00016705

Identifier Type: -

Identifier Source: org_study_id