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

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ClinicalTrials.gov Identifier: NCT03218969
Recruitment Status : Active, not recruiting
First Posted : July 17, 2017
Last Update Posted : July 24, 2018
Sponsor:
Collaborator:
Restless Legs Syndrome Foundation
Information provided by (Responsible Party):
William Ondo, MD, The Methodist Hospital System

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 Type : Interventional  (Clinical Trial)
Estimated 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 : September 18, 2017
Estimated Primary Completion Date : September 15, 2018
Estimated Study Completion Date : October 15, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Restless Legs

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 Name: 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 Name: PSYRX101

Drug: Placebo
matching placebo




Primary Outcome Measures :
  1. International RLS Rating scale [ Time Frame: baseline to end of each treatment arm (6 weeks) ]
    scale

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


Secondary Outcome Measures :
  1. 24 hour RLS diary [ Time Frame: Day 0 (visit 1) to end of each treatment arm (6 weeks) ]
    diary of RLS symptoms

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


Other Outcome Measures:
  1. Hamilton depresion scale [ Time Frame: baseline to end of each treatment arm (6 weeks) ]
    scale

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

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

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

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

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

  7. Vital signs [ Time Frame: baseline to end of each treatment arm (6 weeks) ]
    safety assessment

  8. Physical/Neurological exam [ Time Frame: baseline to end of each treatment arm (6 weeks) ]
    safety assessment

  9. 12 lead ECG [ Time Frame: baseline to end of each treatment arm (6 weeks) ]
    safety assessment



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03218969


Locations
United States, Texas
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 System

Responsible Party: William Ondo, MD, HMRI Principal & Sponsor Investigator: Ondo, The Methodist Hospital System
ClinicalTrials.gov Identifier: NCT03218969     History of Changes
Other Study ID Numbers: Pro#00016705
First Posted: July 17, 2017    Key Record Dates
Last Update Posted: July 24, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
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:
Syndrome
Restless Legs Syndrome
Psychomotor Agitation
Disease
Pathologic Processes
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Parasomnias
Mental Disorders
Ecopipam
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action