Skip to main content
OpenTrials
Completed

NCT Number: NCT03218969

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Restless Legs Syndrome Augmentation Dyssomnias Mental Disorders Nervous System Diseases Parasomnias Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Houston Methodist Hospital

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ecopipam

Drug

oral drug in subjection currently experiencing dopamine agonist induced augmentation

Other names: PSYRX101

Placebo

Drug

matching placebo

Primary outcomes

  1. Change From Baseline (Predose) in Mean International Restless Legs Syndrome (IRLS) Rating Scale at End of Intervention Period

    Time frame: Baseline (Pre-intervention), and at 5 weeks

    IRLS scale is a patient-administered test that measures the severity of restless legs syndrome symptoms. The IRLS scale consists of 10 questions rated from 0 to 4. The total score on symptom severity range from 0 (none) to 40 (worst).

  2. Change From Baseline in Mean Body Part Affected by RLS Symptoms Using Augmentation Severity Rating Scale (ASRS)

    Time frame: Baseline (Pre-intervention), and at 5 weeks

    ASRS scale has three items and probes symptoms over the past week. The first item asks the time at which symptoms began in the last week. The second item probes how quickly symptoms begin when sitting at various times of the day during the past week, and the third item probes which body parts were involved in the past week. Each item has a total of 8 points for a 24-point total scale. 0 is no augmentation and 24 is the most severe augmentation.

    In the third item, participants are asked to shade in the figure the portions of his/her body affected by RLS symptoms for a total of 8 points. The higher the score the worse the outcome

Secondary outcomes

  1. Mean 24 Hour Restless Legs Syndrome (RLS) Diary at End of Intervention

    Time frame: at end of intervention Ecopipam, at end of intervention Placebo

    Patient reported diary of RLS symptoms 72 hours prior to clinic visit. Participants were asked to record the number of hours each day they were bothered by RLS symptoms and when symptoms were present but not bothersome. The range can be 0 (no symptoms) to 72 (uniterupted symptoms)

  2. Number of Participants With Effect on the Clinical Global Impression Scale at the End of the Intervention

    Time frame: At end of intervention Ecopipam, at end of intervention Placebo

    A Modified clinician-administered scale used to evaluate the effect of an intervention on participant symptoms. Responses range from None/worse, mild, Marked or very marked.

Other outcomes

  1. Change in Mean From Baseline Epworth Sleep Scale (ESS) at the End of the Intervention

    Time frame: Baseline (Pre-intervention), and at Week 5

    The ESS is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different activities. The ESS score (the sum of 8 item scores, 0-3) can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity in daily life (ASP), or their 'daytime sleepiness'.

  2. Change in Mean Score From Baseline Montreal Cognitive Assessment (MoCA) at End of Intervention

    Time frame: Baseline (Pre-intervention), and at Week 5

    The Montreal Cognitive Assessment (MoCA) was designed as a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. Score range from 0 - 30 with lower scores reflecting worse outcomes.

Sponsors and collaborators

Lead sponsor

William Ondo, MD

Other

Collaborators

  • Restless Legs Syndrome Foundation

Registry information

Acronym: RLS-Ecopipam

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 17, 2017
Registry last updated
Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.