Ignite Creation Date:
2025-12-24 @ 7:39 PM
Ignite Modification Date:
2026-02-24 @ 8:50 AM
Study NCT ID:
NCT02439203
Status:
COMPLETED
Last Update Posted:
2016-01-13
First Post:
2015-04-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of JM-010 in PD With Levodopa-Induced Dyskinesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D020820', 'term': 'Dyskinesias'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-11', 'studyFirstSubmitDate': '2015-04-30', 'studyFirstSubmitQcDate': '2015-05-07', 'lastUpdatePostDateStruct': {'date': '2016-01-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-05-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Investigator-rated change in dyskinesia severity as assessed by the Abnormal Involuntary Movement Scale (AIMS)', 'timeFrame': '7 Days', 'description': 'Investigator-rated change in dyskinesia severity as assessed by the AIMS after levodopa challenge'}], 'secondaryOutcomes': [{'measure': "Investigator-rated Parkinsonian disability using Unified Parkinson's Disease Rating Scale (UPDRS) Part III", 'timeFrame': '7 Days', 'description': 'Investigator-rated Parkinsonian disability using UPDRS Part III after levodopa challenge'}, {'measure': 'Subject-rated change in PD effects as assessed through daily Dyskinesia Questionnaires', 'timeFrame': 'Daily', 'description': 'Subject-rated change in PD effects as assessed through daily dyskinesia questionnaires'}, {'measure': 'Subject-rated change in dyskinesia severity as assessed by the Clinical Global Impression (CGI) scale', 'timeFrame': '7 Days', 'description': 'Subject-rated change in dyskinesia severity as assessed by the CGI scale'}, {'measure': 'Safety and Tolerability as measured by assessment of abnormalities in physical examinations, safety laboratory examinations, 12-lead electrocardiogram (ECG) and vital signs; collection of adverse events (AEs)', 'timeFrame': '28 Days', 'description': 'Assessment of abnormalities in physical examinations, safety laboratory examinations, 12-lead electrocardiogram (ECG) and vital signs; collection of adverse events (AEs)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Parkinson Disease', 'Levodopa Induced Dyskinesia (LID)', 'Dyskinesia'], 'conditions': ["Parkinson's Disease", 'Levodopa Induced Dyskinesia (LID)']}, 'descriptionModule': {'briefSummary': "The purpose of a randomized, double-blind, placebo-controlled, 2-way crossover study is to evaluate the efficacy, safety/tolerability and pharmacokinetics of JM-010 for the treatment of subjects with Parkinson's Disease (PD) with levodopa-induced dyskinesia (LID)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Written informed consent.\n* Subject with a diagnosis of moderate to severe idiopathic PD with showing responsiveness to levodopa.\n* All anti-Parkinsonian medications and levodopa must be stable for at least 1 week prior to the start of the run-in period.\n* Subject with stable predictable peak-effect LID of at least 2 hours of the awake day and with at least moderately disabling.\n* Amantadine and/or monoamine oxidase (MAO) inhibitor must be stopped at least 2 weeks prior to the start of Treatment Period 1(TP 1).\n\nExclusion Criteria:\n\n* Diagnosis is unclear or a suspicion of other Parkinsonian syndromes exists, such as secondary Parkinsonism, Parkinson-plus syndromes or other neurological degenerative diseases.\n* History of any other brain surgery or surgery for the treatment of PD.\n* Current primary psychiatric diagnosis of acute psychotic disorder or other primary psychiatric diagnoses.\n* A history of psychosis and/or treatment with antipsychotics within 3 months prior to the start of Treatment Period 1(TP1).\n* A history of, or current, seizure disorders and subjects requiring treatment with anti-convulsants.\n* Clinically significant abnormal laboratory data at screening.\n* Clinically relevant ischemic heart symptoms or history of myocardial infarction, coronary artery bypass surgery or percutaneous transluminal coronary angioplasty, within the previous 12 months prior to the start of TP1.\n* History of cerebrovascular accident or transient ischemic attack, coronary vasospasm/Prinzmetal's angina.\n* History of serotonin syndrome.\n* Breast feeding or pregnant women."}, 'identificationModule': {'nctId': 'NCT02439203', 'acronym': 'LID', 'briefTitle': 'Efficacy and Safety of JM-010 in PD With Levodopa-Induced Dyskinesia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bukwang Pharmaceutical'}, 'officialTitle': "A Randomized, Double-blind, Placebo-controlled, 2-way Crossover Study in Subjects With Parkinson's Disease With Moderate to Severe Levodopa-induced Dyskinesia, to Assess the Efficacy, Safety/Tolerability and Pharmacokinetics of JM-010", 'orgStudyIdInfo': {'id': 'JM-010CS01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'JM-010', 'description': 'JM-010', 'interventionNames': ['Drug: JM-010']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'JM-010', 'type': 'DRUG', 'armGroupLabels': ['JM-010']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bloemfontein', 'country': 'South Africa', 'geoPoint': {'lat': -29.12107, 'lon': 26.214}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bukwang Pharmaceutical', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Contera Pharma ApS', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}