Trial | NCT03218969  Report issue

Official Title

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

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    Ecopipam ...

  • Study Participants

    10
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.
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 Started
Sep 18
2017
Primary Completion
Sep 15
2018
Anticipated
Study Completion
Oct 15
2018
Anticipated
Last Update
Jul 24
2018

Drug Ecopipam

oral drug in subjection currently experiencing dopamine agonist induced augmentation

  • Other names: PSYRX101

Drug Placebo

matching placebo

Study period 1 Experimental

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 Experimental

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).

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
No Results Posted