Clinical trial NCT03218969: Treatment of Restless Leg Syndrome (RLS) Augmentation With Ecopipam, a D1 Specific Antagonist
Official title: Treatment of Restless Leg Syndrome (RLS) Augmentation With Ecopipam, a D1 Specific Antagonist
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Restless Legs Syndrome
Augmentation
Lead sponsor: The Methodist Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: Restless Legs Syndrome Foundation
First posted: 2017-07-17
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: International RLS Rating scale
timeFrame: baseline to end of each treatment arm (6 weeks)
measure: Augmentation severity scale
timeFrame: baseline to end of each treatment arm (6 weeks)
Secondary outcomes:
measure: 24 hour RLS diary
timeFrame: Day 0 (visit 1) to end of each treatment arm (6 weeks)
measure: Clinical Global Impression
timeFrame: From start of each treatment arm through one week after treatment withdrawal
Other outcomes:
measure: Hamilton depresion scale
timeFrame: baseline to end of each treatment arm (6 weeks)
measure: MOS sleep scale
timeFrame: baseline to end of each treatment arm (6 weeks)
measure: Fatigue severity scale
timeFrame: baseline to end of each treatment arm (6 weeks)
measure: Columbia Suicide Severity Rating Scale
timeFrame: baseline to end of each treatment arm (6 weeks)
measure: Epworth sleep scale
timeFrame: baseline to end of each treatment arm (6 weeks)
measure: Serum chemistry (liver enzymes ALT and AST)
timeFrame: baseline to end of each treatment arm (6 weeks)
measure: Vital signs
timeFrame: baseline to end of each treatment arm (6 weeks)
measure: Physical/Neurological exam
timeFrame: baseline to end of each treatment arm (6 weeks)
measure: 12 lead ECG
timeFrame: baseline to end of each treatment arm (6 weeks)
Locations:
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
Study officials:
affiliation: The Methodist Hospital Research Institute
name: William G. Ondo, MD
role: PRINCIPAL_INVESTIGATOR
References: