Ignite Creation Date:
2025-12-24 @ 6:49 PM
Ignite Modification Date:
2025-12-29 @ 1:04 AM
Study NCT ID:
NCT05916157
Status:
RECRUITING
Last Update Posted:
2025-05-29
First Post:
2023-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Observational Study of Subcutaneous Infusion of ABBV-951 to Assess Change in Disease Activity and Adverse Events In Adult Japanese Participants With Advanced Parkinson's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-27', 'studyFirstSubmitDate': '2023-06-15', 'studyFirstSubmitQcDate': '2023-06-15', 'lastUpdatePostDateStruct': {'date': '2025-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Experiencing Infusion Site Infections', 'timeFrame': 'Up to 52 Weeks', 'description': 'Percentage of participants with infusion site infections following the commencement of ABBV-951 will be assessed.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ["Parkinson's Disease (PD)", "advanced Parkinson's disease (aPD)", 'ABBV-951'], 'conditions': ["Parkinson's Disease (PD)"]}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.abbvieclinicaltrials.com/study/?id=P23-529', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': "Parkinson's disease (PD) is a neurological condition, which affects the brain. Some symptoms of PD are tremors, stiffness, and slowness of movement. The purpose of this study is to assess how safe and effective ABBV-951 is in treating participants with Parkinson's disease in real world setting.\n\nABBV-951 is an approved drug being developed for the treatment of PD in Japan. Approximately 250 adult participants over 15 years with a diagnosis of PD who are prescribed ABBV-951 by their physicians will be enrolled in this study across Japan.\n\nParticipants will receive ABBV-951 as prescribed their physician and followed for 52 weeks.\n\nThere is expected to be no additional burden for participants in this trial. Study visits may be conducted on-site or virtually as per standard of care."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Adult participants who are prescribed ABBV-951 for the treatment of advanced Parkinson's disease (aPD).", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosed with advanced Parkinson's disease (aPD).\n* Prescribed ABBV-951 as physicians' decision according to the approved label for treatment of aPD.\n* Given informed consent (or by her/his legal representative, if it's a requirement from the participating hospital/clinic) for participating this study.\n\nExclusion Criteria:\n\n* Prior treatment with ABBV-951 for PD.\n* Currently participating in interventional clinical trials."}, 'identificationModule': {'nctId': 'NCT05916157', 'briefTitle': "An Observational Study of Subcutaneous Infusion of ABBV-951 to Assess Change in Disease Activity and Adverse Events In Adult Japanese Participants With Advanced Parkinson's Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': "A Post-marketing Observational Study for ABBV-951 in Patients Diagnosed With Advanced Parkinson's Disease (aPD)", 'orgStudyIdInfo': {'id': 'P23-529'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ABBV-951', 'description': 'Participants will receive ABBV-951 as prescribed by their physician.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '791-8026', 'city': 'Matsuyama', 'state': 'Ehime', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Saiseikai Matsuyama Hospital /ID# 276259', 'geoPoint': {'lat': 33.83916, 'lon': 132.76574}}, {'zip': '070-0901', 'city': 'Asahikawa', 'state': 'Hokkaido', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'National Hospital Organization Asahikawa Medical Center /ID# 269115', 'geoPoint': {'lat': 43.77063, 'lon': 142.36489}}, {'zip': '305-0854', 'city': 'Ryūgasaki', 'state': 'Ibaraki', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Ryugasaki Saiseikai Hospital /ID# 264435', 'geoPoint': {'lat': 35.9, 'lon': 140.18333}}, {'zip': '305-8576', 'city': 'Tsukuba', 'state': 'Ibaraki', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'University of Tsukuba Hospital /ID# 268353', 'geoPoint': {'lat': 36.08333, 'lon': 140.11667}}, {'zip': '890-0067', 'city': 'Kagoshima', 'state': 'Kagoshima-ken', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Okatsu Hospital /ID# 262781', 'geoPoint': {'lat': 31.56667, 'lon': 130.55}}, {'zip': '602-8566', 'city': 'Kyoto', 'state': 'Kyoto', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'University Hospital Kyoto Prefectural University of Medicine /ID# 267445', 'geoPoint': {'lat': 35.02107, 'lon': 135.75385}}, {'zip': '982-8555', 'city': 'Sendai', 'state': 'Miyagi', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Sendai Nishitaga National Hospital /ID# 268349', 'geoPoint': {'lat': 38.26667, 'lon': 140.86667}}, {'zip': '885-0055', 'city': 'Miyakonojo-shi', 'state': 'Miyazaki', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Fujimoto General Hospital /ID# 277287'}, {'zip': '520-2192', 'city': 'Ōtsu', 'state': 'Shiga', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Shiga University of Medical Science Hospital /ID# 265637', 'geoPoint': {'lat': 35.0, 'lon': 135.86667}}, {'zip': '321-0293', 'city': 'Mibu', 'state': 'Tochigi', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Dokkyo Medical University Hospital /ID# 269116', 'geoPoint': {'lat': 36.41667, 'lon': 139.8}}, {'zip': '113-8431', 'city': 'Bunkyo-ku', 'state': 'Tokyo', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Juntendo University Hospital /ID# 264438'}, {'zip': '164-0011', 'city': 'Nakano-ku', 'state': 'Tokyo', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Nitobe Memorial Nakano General Hospital /ID# 275668'}, {'zip': '187-8551', 'city': 'Xiaoping City', 'state': 'Tokyo', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'National Center of Neurology and Psychiatry - Kodaira /ID# 267372'}, {'zip': '616-8255', 'city': 'Kyoto', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'National Hospital Organization Utano Hospital /ID# 268350', 'geoPoint': {'lat': 35.02107, 'lon': 135.75385}}, {'zip': '702-8005', 'city': 'Okayama', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Okayama Neurology Clinic /ID# 269117', 'geoPoint': {'lat': 34.65, 'lon': 133.93333}}, {'zip': '560-0055', 'city': 'Toyonaka', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Municipal Toyonaka Hospital /ID# 271277', 'geoPoint': {'lat': 34.78244, 'lon': 135.46932}}], 'centralContacts': [{'name': 'AbbVie GK Clinical Trial Registration Desk', 'role': 'CONTACT', 'email': 'abbvie_jpn_info_clingov@abbvie.com', 'phone': '+81-3-4577-1111'}], 'overallOfficials': [{'name': 'ABBVIE INC.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}