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

• Sponsor: William Ondo, MD (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03218969
• Collaborator: Restless Legs Syndrome Foundation (Other)
• Enrollment: 10
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 12.9
• Patients Per Site Per Month: 0.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Restless Legs Syndrome; Augmentation	Drug: Ecopipam; Drug: Placebo	Phase 1/Phase 2

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 10 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Masking Description: placebo
• Primary Purpose: Treatment
• Official Title: Treatment of Restless Leg Syndrome (RLS) Augmentation With Ecopipam, a D1 Specific Antagonist
• Actual Study Start Date: Sep 18, 2017
• Anticipated Primary Completion Date: Sep 15, 2018
• Anticipated Study Completion Date: Oct 15, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Study period 1 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).	Drug: Ecopipam; oral drug in subjection currently experiencing dopamine agonist induced augmentation; Other Names: PSYRX101 ; Drug: Placebo; matching placebo
Experimental: Study period 2 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).	Drug: Ecopipam; oral drug in subjection currently experiencing dopamine agonist induced augmentation; Other Names: PSYRX101 ; Drug: Placebo; matching placebo

Outcome Measures

Primary Outcome Measures

1. International RLS Rating scale [baseline to end of each treatment arm (6 weeks)]

   scale

2. Augmentation severity scale [baseline to end of each treatment arm (6 weeks)]

   scale

Secondary Outcome Measures

1. 24 hour RLS diary [Day 0 (visit 1) to end of each treatment arm (6 weeks)]

   diary of RLS symptoms

2. Clinical Global Impression [From start of each treatment arm through one week after treatment withdrawal]

   scale

Other Outcome Measures

1. Hamilton depresion scale [baseline to end of each treatment arm (6 weeks)]

   scale

2. MOS sleep scale [baseline to end of each treatment arm (6 weeks)]

   scale

3. Fatigue severity scale [baseline to end of each treatment arm (6 weeks)]

   scale

4. Columbia Suicide Severity Rating Scale [baseline to end of each treatment arm (6 weeks)]

   scale

5. Epworth sleep scale [baseline to end of each treatment arm (6 weeks)]

   scale

6. Serum chemistry (liver enzymes ALT and AST) [baseline to end of each treatment arm (6 weeks)]

   safety assessment

7. Vital signs [baseline to end of each treatment arm (6 weeks)]

   safety assessment

8. Physical/Neurological exam [baseline to end of each treatment arm (6 weeks)]

   safety assessment

9. 12 lead ECG [baseline to end of each treatment arm (6 weeks)]

   safety assessment

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Houston Methodist Hospital	Houston	Texas	United States	77030

Sponsors and Collaborators

• William Ondo, MD
• Restless Legs Syndrome Foundation

Investigators

• Principal Investigator: William G. Ondo, MD, The Methodist Hospital Research Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: William Ondo, MD, HMRI Principal & Sponsor Investigator: Ondo, The Methodist Hospital Research Institute
• ClinicalTrials.gov Identifier: NCT03218969
• Other Study ID Numbers: Pro#00016705
• First Posted: Jul 17, 2017
• Last Update Posted: Jul 24, 2018
• Last Verified: Jul 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Psychomotor Agitation; Restless Legs Syndrome; Syndrome; Ecopipam

Study Results

No Results Posted as of Jul 24, 2018