Ignite Creation Date:
2025-12-24 @ 2:45 PM
Ignite Modification Date:
2025-12-25 @ 4:13 PM
Study NCT ID:
NCT04857359
Status:
TERMINATED
Last Update Posted:
2025-08-06
First Post:
2021-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dipraglurant (ADX48621) for the Treatment of Patients With Parkinson's Disease Receiving Levodopa-based Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D004409', 'term': 'Dyskinesia, Drug-Induced'}, {'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': 'D020258', 'term': 'Neurotoxicity Syndromes'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D064420', 'term': 'Drug-Related Side Effects and Adverse Reactions'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D011041', 'term': 'Poisoning'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000596095', 'term': '6-fluoro-2-(4-(pyridin-2-yl)but-3-yn-1-yl)imidazo(1,2-a)pyridine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'whyStopped': 'Terminated prior to completing enrollment goals due to COVID-related difficulties in recruiting patients', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-08-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2022-08-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-01', 'studyFirstSubmitDate': '2021-04-21', 'studyFirstSubmitQcDate': '2021-04-21', 'lastUpdatePostDateStruct': {'date': '2025-08-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline on the Unified Dyskinesia Rating Scale (UDysRS) total score', 'timeFrame': 'Baseline (Day 1) to Week 12', 'description': 'The UDysRS is a dyskinesia rating scale scored from 0-104 that evaluates involuntary movements associated with PD. A higher score indicates more severe dyskinesia.'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in ON time without troublesome dyskinesia based on a standardized PD diary', 'timeFrame': 'Baseline (Day 1) to Week 12', 'description': 'A PD home diary is used to score 5 different conditions in 30-minute time intervals: ASLEEP, OFF, ON (ie, had adequate control of PD symptoms) without dyskinesia, ON with non-troublesome dyskinesia, and ON with troublesome dyskinesia.'}, {'measure': 'Change from baseline in OFF time based on a standardized PD diary', 'timeFrame': 'Baseline (Day 1) to Week 12', 'description': 'A PD home diary is used to score 5 different conditions in 30-minute time intervals: ASLEEP, OFF, ON (ie, had adequate control of PD symptoms) without dyskinesia, ON with non-troublesome dyskinesia, and ON with troublesome dyskinesia.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ["Parkinson's disease", 'Dyskinesia', 'Levodopa-induced Dyskinesia'], 'conditions': ['Parkinson Disease', 'Dyskinesia, Drug-Induced', 'Dyskinesias']}, 'descriptionModule': {'briefSummary': 'This study is designed to evaluate the safety and efficacy of dipraglurant in PD patients with dyskinesia (randomized 1:1 to receive active or placebo) for 12 weeks (1 week at 150 mg per day and 11 weeks at 300 mg per day). The primary efficacy assessment will be based on the Unified Dyskinesia Rating Scale (UDysRS). Patients who complete the 12-week blinded treatment period may have the option to roll into an open-label safety extension study for an additional 12-month treatment period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with Parkinson's Disease on a stable regimen of antiparkinson's medications, including a levodopa preparation administered not less than 3 times daily.\n* Meet protocol-specified criteria for moderate to severe dyskinesia symptoms based on UDysRS and Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) assessments.\n* Meet protocol specified criteria for ON time with troublesome dyskinesia based on a standard PD home diary.\n\nExclusion Criteria:\n\n* Prior surgical treatment for Parkinson's Disease (e.g., deep brain stimulation).\n* Other neurological disease (including psychiatric disease and/or cognitive impairment) that, in the opinion of the investigator, would affect the patient's ability to complete study assessments.\n* Other significant medical condition that may affect the safety of the patient or preclude adequate participation in the study.\n* Pregnant or breast-feeding. Female patients who are of child-bearing potential must be using adequate contraceptive methods (e.g. oral contraceptive, double-barrier method, intra-uterine device, intra-muscular hormonal contraceptive), and have a negative pregnancy test at Screening.\n\nOther protocol-defined inclusion and exclusion criteria may apply"}, 'identificationModule': {'nctId': 'NCT04857359', 'briefTitle': "Dipraglurant (ADX48621) for the Treatment of Patients With Parkinson's Disease Receiving Levodopa-based Therapy", 'organization': {'class': 'INDUSTRY', 'fullName': 'Addex Pharma S.A.'}, 'officialTitle': "Phase 2b/3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Dipraglurant (ADX48621) for the Treatment of Dyskinesia in Patients With Parkinson's Disease Receiving Levodopa-based Therapy", 'orgStudyIdInfo': {'id': 'ADX48621-301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dipraglurant TID', 'interventionNames': ['Drug: Dipraglurant']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo TID', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Dipraglurant', 'type': 'DRUG', 'otherNames': ['ADX48621'], 'description': 'Oral 50mg and 100mg tablet', 'armGroupLabels': ['Dipraglurant TID']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Oral matching placebo tablet', 'armGroupLabels': ['Placebo TID']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85004', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Xenosciences Inc', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '93710', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'Neuro-Pain Medical Center', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '92697', 'city': 'Irvine', 'state': 'California', 'country': 'United States', 'facility': 'University of California Irvine Medical Center', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}, {'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford Neuroscience Health Center', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '90503', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Neuroscience Institute', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '80113', 'city': 'Englewood', 'state': 'Colorado', 'country': 'United States', 'facility': 'Rocky Mountain Movement Disorders Center', 'geoPoint': {'lat': 39.64777, 'lon': -104.98776}}, {'zip': '06066', 'city': 'Vernon', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Chase Family Movement Disorders Center - Vernon', 'geoPoint': {'lat': 41.81871, 'lon': -72.47953}}, {'zip': '33486', 'city': 'Boca Raton', 'state': 'Florida', 'country': 'United States', 'facility': "Parkinson's Disease and Movement Disorders Center of Boca Raton Inc", 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}, {'zip': '34471', 'city': 'Ocala', 'state': 'Florida', 'country': 'United States', 'facility': 'Renstar Medical Research -21 NE 1st Ave', 'geoPoint': {'lat': 29.1872, 'lon': -82.14009}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'AES - DRS - Synexus Clinical Research US, Inc. - Orlando', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '32174', 'city': 'Ormond Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Neurology Associates of Ormond Beach', 'geoPoint': {'lat': 29.28581, 'lon': -81.05589}}, {'zip': '33712', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': 'Suncoast Neuroscience Associates Inc', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '33612-4799', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'University of South Florida', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '32960', 'city': 'Vero Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Geodyssey Research LLC', 'geoPoint': {'lat': 27.63864, 'lon': -80.39727}}, {'zip': '30329', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30912', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Augusta University', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '30033', 'city': 'Decatur', 'state': 'Georgia', 'country': 'United States', 'facility': 'NeuroStudies.net, LLC - ClinEdge - PPDS', 'geoPoint': {'lat': 33.77483, 'lon': -84.29631}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush University Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '62702', 'city': 'Springfield', 'state': 'Illinois', 'country': 'United States', 'facility': 'Southern Illinois University School of Medicine', 'geoPoint': {'lat': 39.80172, 'lon': -89.64371}}, {'zip': '46256', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Josephson Wallack Munshower Neurology PC', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '48025-4334', 'city': 'Bingham Farms', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Health System', 'geoPoint': {'lat': 42.51587, 'lon': -83.27326}}, {'zip': '48824', 'city': 'East Lansing', 'state': 'Michigan', 'country': 'United States', 'facility': 'Michigan State University', 'geoPoint': {'lat': 42.73698, 'lon': -84.48387}}, {'zip': '08103', 'city': 'Camden', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Cooper University Hospital', 'geoPoint': {'lat': 39.92595, 'lon': -75.11962}}, {'zip': '08901', 'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Rutgers, the State University of New Jersey', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}, {'zip': '87106-2719', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'University of New Mexico Health Sciences Center', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '11725', 'city': 'Commack', 'state': 'New York', 'country': 'United States', 'facility': 'David L Kreitzman MD PC', 'geoPoint': {'lat': 40.84288, 'lon': -73.29289}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Icahn School of Medicine at Mount Sinai', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Cleveland Clinic Foundation', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43210-1267', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State University Wexner Medical Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '43614', 'city': 'Toledo', 'state': 'Ohio', 'country': 'United States', 'facility': 'University of Toledo, Gardner-McMaster Parkinson Center', 'geoPoint': {'lat': 41.66394, 'lon': -83.55521}}, {'zip': '19001-3816', 'city': 'Abington', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Abington Neurologic Associates', 'geoPoint': {'lat': 40.12067, 'lon': -75.11795}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '57105', 'city': 'Sioux Falls', 'state': 'South Dakota', 'country': 'United States', 'facility': 'Avera Medical Group', 'geoPoint': {'lat': 43.54369, 'lon': -96.72796}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '78229-3901', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'UT Health Science Center, San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '23502-3932', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Meridian Clinical Research (Norfolk, Virginia)', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'zip': '23456', 'city': 'Virginia Beach', 'state': 'Virginia', 'country': 'United States', 'facility': 'Sentara Neurology Specialists', 'geoPoint': {'lat': 36.85293, 'lon': -75.97799}}, {'zip': '98034', 'city': 'Kirkland', 'state': 'Washington', 'country': 'United States', 'facility': 'Evergreen Hospital Medical Center', 'geoPoint': {'lat': 47.68149, 'lon': -122.20874}}, {'zip': '53705', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin Hospitals and Clinics', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}, {'zip': '53226-0509', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Froedtert and The Medical College of Wisconsin', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Addex Pharma S.A.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}