Trial Outcomes & Findings for Treatment of Restless Leg Syndrome (RLS) Augmentation With Ecopipam, a D1 Specific Antagonist (NCT NCT03218969)

10 Participants screened for eligibility between September 2017 through June 2018 at a hospital-associated specialty clinic in Houston, TX

This is a double-blind, exploratory proof of concept, cross over trial where a two week washout period separating group interventions (ecopipam first, then placebo) and (placebo first, then ecopipam) 10 of 10 participants were randomized. Of those randomized, 1 was lost to follow-up

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

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).

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

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)

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.

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'.

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.