Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-31 @ 12:30 PM
Study NCT ID:
NCT06937034
Status:
RECRUITING
Last Update Posted:
2025-08-05
First Post:
2025-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study on Practical ExperienceS of Treatment With Foslevodopa/foScaRbidopa in 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': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-01', 'studyFirstSubmitDate': '2025-04-10', 'studyFirstSubmitQcDate': '2025-04-17', 'lastUpdatePostDateStruct': {'date': '2025-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Base Infusion Rate', 'timeFrame': 'Through end of optimization period (defined as no additional dose modification for at least 15 days since the last dose modification).', 'description': 'Mean base infusion rate (ml/hour) will be assessed'}, {'measure': 'Mean Low Infusion Rate', 'timeFrame': 'Through end of optimization period (defined as no additional dose modification for at least 15 days since the last dose modification).', 'description': 'Mean low infusion rate (ml/hour) will be assessed'}, {'measure': 'Mean High Infusion Rate', 'timeFrame': 'Through end of optimization period (defined as no additional dose modification for at least 15 days since the last dose modification).', 'description': 'Mean high infusion rate (ml/hour) will be assessed'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ["Parkinson's Disease"], 'conditions': ["Parkinson's Disease"]}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.abbvieclinicaltrials.com/study/?id=H25-878', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': "Main objective of this study is to describe the evolution of infusion settings (base, high and low infusion rates) of foslevodopa/foscarbidopa subcutaneous infusion (LDp/CDp) at different timepoints in the treatment of advanced Parkinson's disease (aPD) as captured in ONE-CRM."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Advanced Parkinson Disease Patients treated with foslevodopa/foscarbidopa.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n\\- Diagnosed with levodopa-responsive idiopathic Parkinson's Disease prescribed on LDp/CDp CSCI in routine clinical practice who have consented to be enrolled in the AbbVie Patient Support Program."}, 'identificationModule': {'nctId': 'NCT06937034', 'acronym': 'ORCHESTRA', 'briefTitle': "Study on Practical ExperienceS of Treatment With Foslevodopa/foScaRbidopa in Advanced Parkinson's Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': "Observational Retrospective CoHort Study on Practical ExperienceS of Treatment With Foslevodopa/foScaRbidopa in Advanced Parkinson's Disease", 'orgStudyIdInfo': {'id': 'H25-878'}}, 'armsInterventionsModule': {'armGroups': [{'label': "Participants with Parkinson's Disease", 'description': 'Advanced Parkinson Disease Patients treated with foslevodopa/foscarbidopa.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '8010', 'city': 'Graz', 'state': 'Styria', 'status': 'NOT_YET_RECRUITING', 'country': 'Austria', 'facility': 'Medizinische Universitaet Graz /ID# 278569', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'zip': '7512 KZ', 'city': 'Enschede', 'state': 'Overijssel', 'status': 'RECRUITING', 'country': 'Netherlands', 'facility': 'Medisch Spectrum Twente /ID# 276695', 'geoPoint': {'lat': 52.21833, 'lon': 6.89583}}, {'zip': '300041', 'city': 'Timișoara', 'state': 'Timiș County', 'status': 'RECRUITING', 'country': 'Romania', 'facility': 'Universitatea De Medicină Și Farmacie Victor Babeș /ID# 276720', 'geoPoint': {'lat': 45.75372, 'lon': 21.22571}}, {'zip': '171 64', 'city': 'Solna', 'state': 'Stockholm County', 'status': 'RECRUITING', 'country': 'Sweden', 'facility': 'Karolinska University Hospital Solna /ID# 277116', 'geoPoint': {'lat': 59.36004, 'lon': 18.00086}}], 'centralContacts': [{'name': 'ABBVIE CALL CENTER', 'role': 'CONTACT', 'email': 'abbvieclinicaltrials@abbvie.com', 'phone': '844-663-3742'}], 'overallOfficials': [{'name': 'ABBVIE INC.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}