Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2025-12-28 @ 12:04 AM
Study NCT ID:
NCT05562960
Status:
RECRUITING
Last Update Posted:
2024-12-18
First Post:
2022-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Plasmapheresis in Amyotrophic Lateral Sclerosis With Autoantibody Against NRIP
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000690', 'term': 'Amyotrophic Lateral Sclerosis'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D016472', 'term': 'Motor Neuron Disease'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D057177', 'term': 'TDP-43 Proteinopathies'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D057165', 'term': 'Proteostasis Deficiencies'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010956', 'term': 'Plasmapheresis'}], 'ancestors': [{'id': 'D001781', 'term': 'Blood Component Removal'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D016060', 'term': 'Sorption Detoxification'}, {'id': 'D005112', 'term': 'Extracorporeal Circulation'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-15', 'studyFirstSubmitDate': '2022-09-28', 'studyFirstSubmitQcDate': '2022-09-28', 'lastUpdatePostDateStruct': {'date': '2024-12-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in ALSFRS-R decline', 'timeFrame': 'Before (3-month) and after (3-month) intervention', 'description': 'Change in ALSFRS-R decline before (3-month) and after (3-month) intervention. \\<ALSFRS-R indicates revised ALS functional rating scale, ranged from 0 to 48 with the higher, the better motor function\\>'}], 'secondaryOutcomes': [{'measure': 'Change in ALSFRS-R decline', 'timeFrame': 'Before (3-month) and after (6-month) intervention', 'description': 'Change in ALSFRS-R decline before (3-month) and after (6-month) intervention'}, {'measure': 'Changes in ALSFRS-R score', 'timeFrame': 'Day 0 to days 30, 90, and 180', 'description': 'Changes in ALSFRS-R score from day 0 to days 30, 90, and 180'}, {'measure': 'Change in force vital capacity', 'timeFrame': 'Before intervention and on day 90', 'description': 'Change in force vital capacity before intervention and on day 90'}, {'measure': 'Change in compound motor action potentials', 'timeFrame': 'Before intervention and on day 90', 'description': 'Change in compound motor action potentials before intervention and on day 90'}, {'measure': 'Changes in anti-NRIP titer', 'timeFrame': 'Day 0 to days 30, 90, and 180', 'description': 'Changes in anti-NRIP titer from day 0 to days 30, 90, and 180'}, {'measure': 'Any adverse effect under plasmapheresis', 'timeFrame': 'Within 6 months during and after plasmapheresis', 'description': 'Any adverse effect during and within 6 months after plasmapheresis'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Amyotrophic Lateral Sclerosis', 'Plasmapheresis']}, 'descriptionModule': {'briefSummary': 'Patient with amyotrophic lateral sclerosis (ALS) having anti-NRIP autoantibody showed titer-dependent detrimental Effects. Plasmapheresis might benefit this subgroup of patients via removal of anti-NRIP autoantibody'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with amyotrophic lateral sclerosis (ALS) at the age more than 20 years and having plasma anti-NRIP autoantibody.\n2. Agree to receive plasmapheresis intervention.\n3. Agree to participate in the trial and receive serial examinations and follow up.\n\nExclusion Criteria:\n\n1. Patients without plasma anti-NRIP autoantibody.\n2. Patients requiring permanent ventilator support for ALS progression.\n3. Not able to receive plasmapheresis or trial-related examinations.\n4. Under pregnancy.\n5. Blood fibrinogen level less than 50 mg/dl.\n6. Specific ALS subtypes, including primary lateral sclerosis, progressive muscular atrophy, flail arm syndrome, or flail leg syndrome.'}, 'identificationModule': {'nctId': 'NCT05562960', 'acronym': 'PALATIN', 'briefTitle': 'Plasmapheresis in Amyotrophic Lateral Sclerosis With Autoantibody Against NRIP', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Plasmapheresis in Amyotrophic Lateral Sclerosis With Autoantibody Against NRIP', 'orgStudyIdInfo': {'id': '202202042DINC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'ALS patients receiving plasmapheresis', 'description': 'Plasmapheresis in ALS patients with different titers of autoantibody against NRIP', 'interventionNames': ['Procedure: Plasmapheresis']}], 'interventions': [{'name': 'Plasmapheresis', 'type': 'PROCEDURE', 'description': 'Regular plasmapheresis to remove anti-NRIP autoantibody', 'armGroupLabels': ['ALS patients receiving plasmapheresis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100', 'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Li-Kai Tsai, MD, PhD', 'role': 'CONTACT', 'email': 'milikai@ntuh.gov.tw'}], 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Li-Kai Tsai, MD, PhD', 'role': 'CONTACT', 'email': 'milikai@ntuh.gov.tw', 'phone': '886-2-23123456', 'phoneExt': '63476'}], 'overallOfficials': [{'name': 'Li-Kai Tsai, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Taiwan University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}