Back to resultsTreatment of Restless Leg Syndrome (RLS) Augmentation With Ecopipam, a D1 Specific Antagonist (RLS-Ecopipam)
Primary Purpose
Restless Legs Syndrome, Augmentation
Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Ecopipam
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Restless Legs Syndrome
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
Sites / Locations
- Houston Methodist Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Study period 1
Study period 2
Arm Description
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).
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).
Outcomes
Primary Outcome Measures
International RLS Rating scale
scale
Augmentation severity scale
scale
Secondary Outcome Measures
24 hour RLS diary
diary of RLS symptoms
Clinical Global Impression
scale
Full Information
NCT ID
NCT03218969
First Posted
April 21, 2017
Last Updated
July 20, 2018
Sponsor
William Ondo, MD
Collaborators
Restless Legs Syndrome Foundation
1. Study Identification
Unique Protocol Identification Number
NCT03218969
Brief Title
Treatment of Restless Leg Syndrome (RLS) Augmentation With Ecopipam, a D1 Specific Antagonist
Acronym
RLS-Ecopipam
Official Title
Treatment of Restless Leg Syndrome (RLS) Augmentation With Ecopipam, a D1 Specific Antagonist
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 18, 2017 (Actual)
Primary Completion Date
September 15, 2018 (Anticipated)
Study Completion Date
October 15, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
William Ondo, MD
Collaborators
Restless Legs Syndrome Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Restless Legs Syndrome, Augmentation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Masking Description
placebo
Allocation
Randomized
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Study period 1
Arm Type
Experimental
Arm Description
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).
Arm Title
Study period 2
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Ecopipam
Other Intervention Name(s)
PSYRX101
Intervention Description
oral drug in subjection currently experiencing dopamine agonist induced augmentation
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
matching placebo
Primary Outcome Measure Information:
Title
International RLS Rating scale
Description
scale
Time Frame
baseline to end of each treatment arm (6 weeks)
Title
Augmentation severity scale
Description
scale
Time Frame
baseline to end of each treatment arm (6 weeks)
Secondary Outcome Measure Information:
Title
24 hour RLS diary
Description
diary of RLS symptoms
Time Frame
Day 0 (visit 1) to end of each treatment arm (6 weeks)
Title
Clinical Global Impression
Description
scale
Time Frame
From start of each treatment arm through one week after treatment withdrawal
Other Pre-specified Outcome Measures:
Title
Hamilton depresion scale
Description
scale
Time Frame
baseline to end of each treatment arm (6 weeks)
Title
MOS sleep scale
Description
scale
Time Frame
baseline to end of each treatment arm (6 weeks)
Title
Fatigue severity scale
Description
scale
Time Frame
baseline to end of each treatment arm (6 weeks)
Title
Columbia Suicide Severity Rating Scale
Description
scale
Time Frame
baseline to end of each treatment arm (6 weeks)
Title
Epworth sleep scale
Description
scale
Time Frame
baseline to end of each treatment arm (6 weeks)
Title
Serum chemistry (liver enzymes ALT and AST)
Description
safety assessment
Time Frame
baseline to end of each treatment arm (6 weeks)
Title
Vital signs
Description
safety assessment
Time Frame
baseline to end of each treatment arm (6 weeks)
Title
Physical/Neurological exam
Description
safety assessment
Time Frame
baseline to end of each treatment arm (6 weeks)
Title
12 lead ECG
Description
safety assessment
Time Frame
baseline to end of each treatment arm (6 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William G. Ondo, MD
Organizational Affiliation
The Methodist Hospital Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Houston Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Treatment of Restless Leg Syndrome (RLS) Augmentation With Ecopipam, a D1 Specific Antagonist
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