Ignite Creation Date:
2025-12-24 @ 4:07 PM
Ignite Modification Date:
2026-01-01 @ 7:15 AM
Study NCT ID:
NCT07197866
Status:
RECRUITING
Last Update Posted:
2025-12-17
First Post:
2025-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Extension Trial to Test if TEV-56286 is Effective in Relieving Multiple System Atrophy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019578', 'term': 'Multiple System Atrophy'}], 'ancestors': [{'id': 'D054969', 'term': 'Primary Dysautonomias'}, {'id': 'D001342', 'term': 'Autonomic Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2029-05-17', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-10', 'studyFirstSubmitDate': '2025-09-26', 'studyFirstSubmitQcDate': '2025-09-26', 'lastUpdatePostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2029-05-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants experiencing an adverse event', 'timeFrame': 'Baseline to Week 100'}, {'measure': 'Number of participants who withdrew from the trial due to an adverse event', 'timeFrame': 'Baseline to Week 100'}], 'secondaryOutcomes': [{'measure': 'Number of participants with potentially clinically significant vital sign values', 'timeFrame': 'Baseline to Week 96'}, {'measure': 'Number of participants with potentially clinically significant laboratory test values (hematology and chemistry)', 'timeFrame': 'Baseline to Week 96'}, {'measure': 'Number of participants with potentially clinically significant 12-lead ECG measurements', 'timeFrame': 'Baseline to Week 96'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Multiple System Atrophy']}, 'descriptionModule': {'briefSummary': 'The primary objective of the trial is to describe the long-term safety and tolerability of TEV-56286 administered orally for the treatment of adult participants with Multiple System Atrophy (MSA).\n\nA secondary objective of the trial is to further describe the safety and tolerability of TEV-56286.\n\nThe planned total duration of the trial is approximately 100 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Completion of the treatment period and the week 48(V9) visit of the double-blind trial (TV56286-NDG-20039) whilst remaining compliant with trial requirements\n* Females of childbearing potential may be included only if they have a negative pregnancy test at the baseline visit\n* Females of childbearing potential whose male partners are potentially fertile (ie, no vasectomy) must use highly effective birth control methods for the duration of the trial and for 28 days after the last does of IMP\n* Males who are potentially fertile/reproductively competent (not surgically \\[eg, vasectomy\\] or congenitally sterile) and their female partners who are of childbearing potential must use, together with their female partners, highly effective birth control methods for the duration of the trial and for 28 days after the last dose of investigational medicinal product\n\nNOTE - Additional criteria apply, please contact the investigator for more information\n\nExclusion Criteria:\n\n* Is a female participant who is pregnant, plans to become pregnant, or is breastfeeding during the trial\n* Is of a vulnerable population (eg, people kept in detention or jail)\n* Is using or consuming any prohibited concomitant medications within the specified exclusionary windows of this trial\n\nNote - Additional criteria apply, please contact the investigator for more information'}, 'identificationModule': {'nctId': 'NCT07197866', 'briefTitle': 'An Extension Trial to Test if TEV-56286 is Effective in Relieving Multiple System Atrophy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Teva Branded Pharmaceutical Products R&D, Inc.'}, 'officialTitle': 'An Open-Label Extension, Multi-Centered, Phase 2 Trial to Describe the Safety and Efficacy of TEV-56286 (Emrusolmin) in Participants With Multiple System Atrophy', 'orgStudyIdInfo': {'id': 'TV56286-NDG-20041'}, 'secondaryIdInfos': [{'id': '2025-521642-14-00', 'type': 'CTIS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TEV-56286', 'interventionNames': ['Drug: TEV-56286']}], 'interventions': [{'name': 'TEV-56286', 'type': 'DRUG', 'otherNames': ['Emrusolmin'], 'description': 'administered orally', 'armGroupLabels': ['TEV-56286']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33486', 'city': 'Boca Raton', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Teva Investigational Site 15544', 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}, {'zip': '99202', 'city': 'Spokane', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Teva Investigational Site 15543', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}], 'centralContacts': [{'name': 'Teva U.S. Medical Information', 'role': 'CONTACT', 'email': 'USMedInfo@tevapharm.com', 'phone': '1-888-483-8279'}], 'overallOfficials': [{'name': 'Teva Medical Expert, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Teva Branded Pharmaceutical Products R&D LLC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be assessed for scientific merit, product approval status, and conflicts of interest. If the request is approved, patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please email USMedInfo@tevapharm.com to make your request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Teva Branded Pharmaceutical Products R&D LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}