Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2026-01-07 @ 12:31 AM
Study NCT ID:
NCT03218969
Status:
UNKNOWN
Last Update Posted:
2018-07-24
First Post:
2017-04-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Restless Leg Syndrome (RLS) Augmentation With Ecopipam, a D1 Specific Antagonist
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2019-09-17', 'releaseDate': '2019-08-28'}, {'resetDate': '2020-02-12', 'releaseDate': '2020-01-23'}, {'releaseDate': '2025-12-11'}], 'estimatedResultsFirstSubmitDate': '2019-08-28'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D012148', 'term': 'Restless Legs Syndrome'}], 'ancestors': [{'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D020447', 'term': 'Parasomnias'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C058081', 'term': 'ecopipam'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'placebo'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-09-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2018-10-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-07-20', 'studyFirstSubmitDate': '2017-04-21', 'studyFirstSubmitQcDate': '2017-07-12', 'lastUpdatePostDateStruct': {'date': '2018-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Hamilton depresion scale', 'timeFrame': 'baseline to end of each treatment arm (6 weeks)', 'description': 'scale'}, {'measure': 'MOS sleep scale', 'timeFrame': 'baseline to end of each treatment arm (6 weeks)', 'description': 'scale'}, {'measure': 'Fatigue severity scale', 'timeFrame': 'baseline to end of each treatment arm (6 weeks)', 'description': 'scale'}, {'measure': 'Columbia Suicide Severity Rating Scale', 'timeFrame': 'baseline to end of each treatment arm (6 weeks)', 'description': 'scale'}, {'measure': 'Epworth sleep scale', 'timeFrame': 'baseline to end of each treatment arm (6 weeks)', 'description': 'scale'}, {'measure': 'Serum chemistry (liver enzymes ALT and AST)', 'timeFrame': 'baseline to end of each treatment arm (6 weeks)', 'description': 'safety assessment'}, {'measure': 'Vital signs', 'timeFrame': 'baseline to end of each treatment arm (6 weeks)', 'description': 'safety assessment'}, {'measure': 'Physical/Neurological exam', 'timeFrame': 'baseline to end of each treatment arm (6 weeks)', 'description': 'safety assessment'}, {'measure': '12 lead ECG', 'timeFrame': 'baseline to end of each treatment arm (6 weeks)', 'description': 'safety assessment'}], 'primaryOutcomes': [{'measure': 'International RLS Rating scale', 'timeFrame': 'baseline to end of each treatment arm (6 weeks)', 'description': 'scale'}, {'measure': 'Augmentation severity scale', 'timeFrame': 'baseline to end of each treatment arm (6 weeks)', 'description': 'scale'}], 'secondaryOutcomes': [{'measure': '24 hour RLS diary', 'timeFrame': 'Day 0 (visit 1) to end of each treatment arm (6 weeks)', 'description': 'diary of RLS symptoms'}, {'measure': 'Clinical Global Impression', 'timeFrame': 'From start of each treatment arm through one week after treatment withdrawal', 'description': 'scale'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Restless Legs Syndrome', 'Augmentation']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provide consent to participate in the study\n* Individuals of either sex, 21-80 years of age\n* Clinically defined Restless Leg Syndrome, and problematic augmentation currently on monotherapy with dopaminergic treatment.\n\nExclusion Criteria:\n\n* Current use of Opioid medications\n* Clinical relevant depression or other medical problems that in the opinion of the investigator would not allow for safe completion of the protocol.\n* Suicidal ideation\n* History of epilepsy\n* Current MAO inhibitors'}, 'identificationModule': {'nctId': 'NCT03218969', 'acronym': 'RLS-Ecopipam', 'briefTitle': 'Treatment of Restless Leg Syndrome (RLS) Augmentation With Ecopipam, a D1 Specific Antagonist', 'organization': {'class': 'OTHER', 'fullName': 'The Methodist Hospital Research Institute'}, 'officialTitle': 'Treatment of Restless Leg Syndrome (RLS) Augmentation With Ecopipam, a D1 Specific Antagonist', 'orgStudyIdInfo': {'id': 'Pro#00016705'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study period 1', 'description': '* Ecopipam or matching placebo 25 mg by mouth for 7 days (week 1), followed by\n* Ecopipam or matching placebo 50 mg by mouth for 7 days (week 2), followed by\n* Ecopipam or matching placebo 100 mg by mouth for 23 days (weeks 3).', 'interventionNames': ['Drug: Ecopipam', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Study period 2', 'description': '* Matching placebo or ecopipam 25 mg by mouth for 7 days (week 7), followed by\n* Matching placebo or ecopipam 50 mg by mouth for 7 days (week 8), followed by\n* Matching placebo or ecopipam 100 mg by mouth for 23 days (week 9).', 'interventionNames': ['Drug: Ecopipam', 'Drug: Placebo']}], 'interventions': [{'name': 'Ecopipam', 'type': 'DRUG', 'otherNames': ['PSYRX101'], 'description': 'oral drug in subjection currently experiencing dopamine agonist induced augmentation', 'armGroupLabels': ['Study period 1', 'Study period 2']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'matching placebo', 'armGroupLabels': ['Study period 1', 'Study period 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Houston Methodist Hospital', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'William G. Ondo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Methodist Hospital Research Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'William Ondo, MD', 'class': 'OTHER'}, 'collaborators': [{'name': 'Restless Legs Syndrome Foundation', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'HMRI Principal & Sponsor Investigator: Ondo', 'investigatorFullName': 'William Ondo, MD', 'investigatorAffiliation': 'The Methodist Hospital Research Institute'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2019-08-28', 'type': 'RELEASE'}, {'date': '2019-09-17', 'type': 'RESET'}, {'date': '2020-01-23', 'type': 'RELEASE'}, {'date': '2020-02-12', 'type': 'RESET'}], 'unpostedResponsibleParty': 'William Ondo, MD, Principal Investigator, The Methodist Hospital Research Institute'}}}}