Ignite Creation Date:
2025-12-24 @ 2:58 PM
Ignite Modification Date:
2025-12-28 @ 12:47 AM
Study NCT ID:
NCT05122559
Status:
RECRUITING
Last Update Posted:
2025-06-06
First Post:
2021-11-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neuroprotection With N-acetyl Cysteine for Patients With Progressive Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'id': 'D020528', 'term': 'Multiple Sclerosis, Chronic Progressive'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000111', 'term': 'Acetylcysteine'}], 'ancestors': [{'id': 'D003545', 'term': 'Cysteine'}, {'id': 'D000603', 'term': 'Amino Acids, Sulfur'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 98}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-02-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2027-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-03', 'studyFirstSubmitDate': '2021-11-08', 'studyFirstSubmitQcDate': '2021-11-08', 'lastUpdatePostDateStruct': {'date': '2025-06-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Effect of NAC on progression of MS', 'timeFrame': '15 months', 'description': 'Monitoring progression using imaging metrics and changes captured by a wearable multi-sensor device.'}], 'primaryOutcomes': [{'measure': 'Safety and tolerability', 'timeFrame': '15 months', 'description': 'Number of adverse events recorded by system, severity, and by relationship to treatment arm.'}, {'measure': 'Effect of NAC on on progression of brain, thalamic and cervical cord atrophy', 'timeFrame': '15 months', 'description': 'The primary endpoint is brain, thalamic and cord atrophy measured by brain and cervical spine MRI at month 3 and month 15.'}], 'secondaryOutcomes': [{'measure': 'Clinical effects of NAC', 'timeFrame': '15 months', 'description': 'Clinical effects in MS as measured by the 9-HPT, 25-foot walk, symbol digit modalities test (SDMT).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Multiple Sclerosis', 'Multiple Sclerosis, Primary Progressive', 'Multiple Sclerosis, Secondary Progressive']}, 'referencesModule': {'references': [{'pmid': '36182028', 'type': 'DERIVED', 'citation': 'Schoeps VA, Graves JS, Stern WA, Zhang L, Nourbakhsh B, Mowry EM, Henry RG, Waubant E. N-Acetyl Cysteine as a Neuroprotective Agent in Progressive Multiple Sclerosis (NACPMS) trial: Study protocol for a randomized, double-blind, placebo-controlled add-on phase 2 trial. Contemp Clin Trials. 2022 Nov;122:106941. doi: 10.1016/j.cct.2022.106941. Epub 2022 Sep 28.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates the effectiveness of N-acetyl cysteine (NAC) in the treatment of progressive multiple sclerosis. Half of the patients will receive NAC, while the other half will receive a placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\- 40-70 (inclusive) years in age,\n* meet 2017 McDonald criteria (Thompson 2018),\n* patients with primary or secondary progressive MS (Thompson 2018),\n* at least 2 years since progressive symptom onset,\n* evidence of clinical changes over the previous 2 years unrelated to relapses: increased EDSS or 20% slowing on 25-foot walk, change of ambulatory support, cognitive change documented on cognitive testing. Progression defined by patients in terms of ambulation perimeter or type of support to ambulate are acceptable if aforementioned physician-based measure changes are not available.\n* EDSS score 3.0 to 7.0 (inclusive),\n* can be on a stable disease-modifying treatment initiated \\> 3 months prior to screening,\n* can be on stable doses of dalfampridine initiated at least one month before screening.\n\nExclusion Criteria:\n\n* \\- MS relapses in the previous 6 months\n* oral glucocorticosteroid treatment within the prior 3 months\n* patient with issues undergoing MRI scans\n* pregnancy or breastfeeding\n* women of child-bearing potential not able to utilize an effective form of contraception for the duration of the study\n* history of bleeding disorders\n* active gastrointestinal ulcers\n* abnormal liver function testing (aminotransferase (AST) or alanine aminotransferase (ALT) \\>2 times upper limit of normal)\n* current treatment for active malignancy or metastatic malignancy treated in the past year\n* alcohol or substance use disorder\n* allergy to NAC\n* planned surgery or move within 15 months\n* use of medications/supplements with antioxidant properties (including over-the-counter NAC)'}, 'identificationModule': {'nctId': 'NCT05122559', 'acronym': 'NACPMS', 'briefTitle': 'Neuroprotection With N-acetyl Cysteine for Patients With Progressive Multiple Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Randomized Controlled Trial of N-acetyl Cysteine as a Neuroprotective Agent in Progressive Multiple Sclerosis', 'orgStudyIdInfo': {'id': 'P0549747'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'N-acetyl cysteine', 'description': 'N-acetyl cysteine (NAC) 1200mg t.i.d.', 'interventionNames': ['Drug: N-acetyl cysteine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo 1200mg t.i.d.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'N-acetyl cysteine', 'type': 'DRUG', 'otherNames': ['NAC'], 'description': 'N-acetyl cysteine (NAC) is a Glutathione (GSH) precursor with antioxidant properties which make it relevant for neuroprotection.', 'armGroupLabels': ['N-acetyl cysteine']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Lactose Monohydrate, USP (100%), magnesium stearate, silicon dioxide NF', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94158', 'city': 'San Francisco', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Uk Sok Shin, B.A.', 'role': 'CONTACT', 'email': 'uksok.shin@ucsf.edu', 'phone': '(415) 321-9373'}, {'name': 'Alina Dobai, M.D.', 'role': 'CONTACT', 'email': 'AlinaLoredana.Dobai@ucsf.edu', 'phone': '415-476-4882'}], 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'centralContacts': [{'name': 'Uk Sok Shin, BA', 'role': 'CONTACT', 'email': 'uksok.shin@ucsf.edu', 'phone': '(415) 321-9373'}, {'name': 'Emmanuelle Waubant, MD, PhD', 'role': 'CONTACT', 'email': 'emmanuelle.waubant@ucsf.edu', 'phone': '415-514-8199'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emmanuelle Waubant, MD PhD', 'class': 'OTHER'}, 'collaborators': [{'name': 'United States Department of Defense', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor, Neurology UCSF Weill Institute for Neurosciences', 'investigatorFullName': 'Emmanuelle Waubant, MD PhD', 'investigatorAffiliation': 'University of California, San Francisco'}}}}