Ignite Creation Date:
2025-12-25 @ 4:29 AM
Ignite Modification Date:
2025-12-26 @ 3:32 AM
Study NCT ID:
NCT07288320
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-17
First Post:
2025-12-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
An Assessment of Efficacy, Safety, and Pharmacokinetics of NBI-1117568 in Adults With Bipolar I Disorder With Current Mania
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000087122', 'term': 'Mania'}], 'ancestors': [{'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-15', 'studyFirstSubmitDate': '2025-12-15', 'studyFirstSubmitQcDate': '2025-12-15', 'lastUpdatePostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Day 21', 'timeFrame': 'Baseline, Day 21'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Clinical Global Impression - Severity Scale (CGI-S) Score at Day 21', 'timeFrame': 'Baseline, Day 21'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bipolar I Disorder', 'Mania', 'NBI-1117568'], 'conditions': ['Bipolar I Disorder', 'Mania']}, 'descriptionModule': {'briefSummary': 'The primary objective for this study is to evaluate the efficacy of NBI-1117568 compared with placebo on improving manic symptoms in adults with bipolar I disorder who are currently experiencing an episode of mania with or without mixed features.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Participant has a primary diagnosis of bipolar I disorder.\n* The participant has had at least 1 prior documented manic episode that required treatment.\n* The participant is experiencing an acute manic episode or manic episode with mixed features, with or without psychotic symptoms.\n\nKey Exclusion Criteria:\n\n* Any unstable or poorly controlled medical condition or chronic disease (including history of neurological, hepatic, renal, cardiovascular, gastrointestinal, pulmonary, autoimmune, or endocrine disease that may affect study participation or results), or malignancy within 90 days before the start of screening.\n* Primary diagnosis is not bipolar I disorder.\n* History of clozapine treatment for treatment-resistant psychosis.\n* History of psychiatric hospitalization(s) for ≥30 consecutive days during the 90 days before the start of screening.\n\nNote: Additional inclusion/exclusion criteria may apply, per protocol.'}, 'identificationModule': {'nctId': 'NCT07288320', 'briefTitle': 'An Assessment of Efficacy, Safety, and Pharmacokinetics of NBI-1117568 in Adults With Bipolar I Disorder With Current Mania', 'organization': {'class': 'INDUSTRY', 'fullName': 'Neurocrine Biosciences'}, 'officialTitle': 'A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Pharmacokinetics of NBI-1117568 in Adults With Bipolar I Disorder Who Are Currently Experiencing a Manic Episode or Manic Episode With Mixed Features, With or Without Psychotic Symptoms, and Warrant Inpatient Hospitalization', 'orgStudyIdInfo': {'id': 'NBI-1117568-BPD2036'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NBI-1117568', 'description': 'Participants will receive NBI-1117568.', 'interventionNames': ['Drug: NBI-1117568']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will receive placebo matching NBI-1117568.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'NBI-1117568', 'type': 'DRUG', 'description': 'Oral administration', 'armGroupLabels': ['NBI-1117568']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Oral administration', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Neurocrine Medical Information Call Center', 'role': 'CONTACT', 'email': 'medinfo@neurocrine.com', 'phone': '1-877-641-3461'}], 'overallOfficials': [{'name': 'Clinical Development Lead', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Neurocrine Biosciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Neurocrine Biosciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}