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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Restless Legs Syndrome, Augmentation

Intervention / Treatment
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* Drug: Ecopipam
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study period 1<br>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). | Drug: Ecopipam<br>* oral drug in subjection currently experiencing dopamine agonist induced augmentation<br>* Other names: PSYRX101;Drug: Placebo<br>* matching placebo<br>|
| Experimental: Study period 2<br>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). | Drug: Ecopipam<br>* oral drug in subjection currently experiencing dopamine agonist induced augmentation<br>* Other names: PSYRX101;Drug: Placebo<br>* matching placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International RLS Rating scale | scale | baseline to end of each treatment arm (6 weeks) | 
| Augmentation severity scale | scale | baseline to end of each treatment arm (6 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24 hour RLS diary | diary of RLS symptoms | Day 0 (visit 1) to end of each treatment arm (6 weeks) | 
| Clinical Global Impression | scale | From start of each treatment arm through one week after treatment withdrawal |