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A Study to Assess the Long-term Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-3)

StatusRecruiting
PhasePhase 3
Started2025-07-18
View on ClinicalTrials.gov ↗

Amendment history

2026-09-11
Study Status, Contacts/Locations v30
Trial sites expanded: 174 → 182 locations
2026-08-24
Study Status, Contacts/Locations v29
Study sites174 entries, revised
LocalGlostrup InstitutionHospital Nyírő -Gyula 0154Országos Pszichiátriai és Addiktológiai Intézet LocalBarzilai InstitutionMedical -Center Univerzitna 0110 LocalNemocnica InstitutionL. -Pasteura 0173 Local Institution - 0118Kosice
2026-07-23
Study Status, Eligibility, Contacts/Locations v28
Study sites175→174
Eligibility criteria+21 characters
[...] equire hospitalization for acute mania. Exclusion Criteria: All participants: 1. ⇅ moved All participants with a risk for suicidal behavior at baseline as determined by Investigator's clinical assessment or history of suicidal behavior as assessed on C-SSRS. Participants who participated in double-blind placebo-controlled study (CN0120036, CN0120037, or CN0120046): a1. Discontinuation from any KarXT parent studies. De novo par [...]
2026-07-14
Study Status, Contacts/Locations v27
Trial sites expanded: 172 → 175 locations
2026-06-23
Study Status, Contacts/Locations v26
Study sites173→172
Show 25 earlier versions
2026-06-01
Study Status, Contacts/Locations v25
Study sites172→173
2026-05-11
Study Status, Contacts/Locations v24
Study sites170→172
2026-04-22
Study Status, Contacts/Locations v23
Study sites170 entries, revised
LocalNess InstitutionZiona -Mental 0075Health Center LocalInstytut InstitutionPsychiatrii -i 0092Neurologii LocalM2M Institution - 0089Med
2026-04-02
Study Status, Contacts/Locations v22
Study sites170 entries, revised
LocalOmega InstitutionClinical Trials - 0137La Habra LocalResearch InstitutionCenters of America ( Hollywood ) Community Clinical Research Prime Clinical Research - 0053Mansfield LocalPsihijatrijska Institutionbolnica -"Sveti 0134Ivan" LocalCentrum InstitutionMedyczne -HCP Klinika 0139Psychiatrii Uniwersytet Medyczny w Białymstoku LocalSpitalul Institutionde -Psihiatrie 0019 Localși InstitutionNeurologie - 0088 Local Institution - 0090 Local Institution - 0100Brașov
2026-03-16
Study Status, Contacts/Locations v21
Study sites169→170
2026-03-02
Study Status, Contacts/Locations v20
Study sites170→169
2026-02-17
Study Status, Contacts/Locations v19
Study sites170 entries, revised
LocalMHAT Institution"Dr. -Ival 0113Seliminski" LocalMiyazaki InstitutionPrefectural -Miyazaki 0004Hospital
2026-02-02
Study Status, Contacts/Locations, IPDSharing v18
Study sites169→170
2026-01-21
Study Status, Contacts/Locations v17
Study sites157→169
2025-12-22
Study Status, Contacts/Locations v16
Study sites153→157
2025-12-10
Study Status, Contacts/Locations v15
Study sites153 entries, revised
LocalHassman InstitutionResearch Institute Marlton Site University of Cincinnati Medical Center Mental Health Center - 0130Vratsa LocalSemmelweis InstitutionEgyetem Shalvata -Mental 0055Health Center LocalKfar InstitutionShaul -Mental 0114 LocalHealth Institution - 0108 Local Institution - 0068 Local Institution - 0074Center
2025-12-01
Study Status, Contacts/Locations v14
Study sites152→153
2025-11-10
Study Status, Contacts/Locations v13
Study sites143→152
2025-11-04
Study Status, Contacts/Locations v12
Study sites143 entries, revised
LocalWoodland InstitutionInternational -Research 0038Group LocalArch InstitutionClinical -Trials Centrul 0042 Localde InstitutionEvaluare -și 0104Tratament a Toxicodependenței pentru Tineri Sf.Stelian
2025-10-22
Study Status, Contacts/Locations v11
Study sites141→143
2025-10-14
Study Identification, Study Status, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations, IPDSharing v10
Enrollment target300→450
InterventionsKarXT (Drug)→KarXT (Drug), Lamotrigine (Drug), Lithium (Drug), Valproate (Drug)
Eligibility criteria+57 characters
Inclusion Criteria: Participants who participated in double-blind placebo-controlled study (CN0120036, CN0120037, or CN0120037CN0120046): a. Participants must have completed treatment period of p [...] icipated in double-blind placebo-controlled study (CN0120036, CN0120037, or CN0120037CN0120046): a. Discontinuation from any KarXT parent studies. De novo [...] nths only), Bipolar-II disorder, major depressive disorder, borderline personality disorder, and primary psychotic disorder, with the exception of mild a [...]
Secondary endpoints8 entries, revised
ChnageChange from baseline in Abnormal Involuntary Movement Scale (AIMS) score
Study sites141 entries, revised
LocalAdvanced InstitutionResearch Institute of Miami Richmond Behavioral Associates Be'er Sheva Mental Health Center Goryokai Medical Corporation - 0028Goryokai Hospital National Center of Neurology and Psychiatry Prof. Dr. Alexandru Obregia Psychiatry Hospital Nacka Local Institution - 0033 Local Institution - 0106 Local Institution - 0005 Local Institution - 0072 Local Institution - 0102 Local Institution - 0125Hospital
2025-10-07
Study Status, Contacts/Locations v9
Study sites129→141
2025-10-06
Study Status, Contacts/Locations v8
Study sites129 entries, revised
LocalProscience InstitutionResearch Group NRC Research Institute Innovative Clinical Research, Inc. South Florida Research Phase I-IV Synexus 0037Clinical Research US, Inc. LocalCenExel InstitutioniResearch, LLC InSite Clinical Research Ramsay Clinic New Farm Sheba Medical Center Okehazama Hospital Osaka Metropolitan University Hospital Prof. Dr. Alexandru Obregia Psychiatry Hospital Prof. Dr. Alexandru Obregia Psychiatry Hospital Osi Bilbao-Basurto Hospital 0039 LocalClínic Institutionde - 0047 Local Institution - 0025 Local Institution - 0052 Local Institution - 0023 Local Institution - 0048 [...] [...]
2025-09-15
Study Status, Contacts/Locations v7
Study sites126→129
2025-09-01
Study Status, Contacts/Locations v6
Study sites125→126
2025-08-14
Study Status, Contacts/Locations v5
Study sites124→125
2025-07-29
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v4
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-07-22→confirmed 2025-07-18
Study sites123→124
2025-06-19
Study Status, Contacts/Locations v3
Study sites122→123
2025-05-27
Study Status, Contacts/Locations v2
Study sites119→122
2025-05-02
Study Status, Contacts/Locations, References v1
Study sites110→119
2025-04-14
Original filing
This is a phase 3, open-label extension study to assess the long-term safety of KarXT for the treatment of mania or mania with mixed features in Bipolar-I disorder (BP-I) The primary objective of the study is to evaluate the long-term safety and tolerability of KarXT in the treatment of participants with mania or mania with mixed features associated with BP-I.
Trial Details
NCT Number NCT06929273
Lead Sponsor Bristol-Myers Squibb
Conditions Bipolar Disorder Type I With Mania
Enrollment 450 participants
Start Date 2025-07-18
Primary Completion 2028-06-13 (estimated)
Study Completion 2028-06-13 (estimated)
Updated on ClinicalTrials.gov 2026-09-14