Health Condition 1: F318- Other bipolar disorders
Conditions
Interventions
Intervention1: KarXT: Study Arm(s)
Arm Title / Arm Use: KarXT
Intervention Description / Dosage Levels: 50 mg/20 mg OR 75 mg/20 mg OR 100 mg/20 mg OR 125 mg/30 mg
Route of Administration: Oral
Contro
Sponsors
BRISTOL MYERS SQUIBB INDIA PRIVATE LIMITED
Eligibility
Inclusion criteria
Inclusion criteria: Signed Written Informed Consent 1)Participants must be able and willing to sign and date an IRB/IEC-approved written ICF in accordance with regulatory, local, and institutional guidelines. This ICF must be obtained before performing any protocol-related procedures that are not part of normal patient care. Participant must be fluent in the language of the ICF to consent. Type of Participant and Target Disease Characteristics 2)Completed treatment period of the parent study (CN0120036, orCN0120037). 3)Able to comprehend and satisfactorily comply with protocol requirements per investigator judgment. Reproductive Status Note: The investigator or designee shall counsel IOCBP participants (as defined in APPENDIX 3) and male (as assigned at birth) participants who are sexually active with IOCBP on the importance of pregnancy prevention and the implications of an unexpected pregnancy. Note: The investigator or designee shall evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention. Note: Local laws and regulations may require the use of alternative and/or additional contraceptive methods.(See APPENDIX 4) 4)Female (as assigned at birth) participants: Note: Female (as assigned at birth) participants who are not of childbearing potential (as defined in APPENDIX 3) must have documented proof. Note: Documentation can be obtained from the site personnel s review of the participant s medical records, medical examination, or medical history interview. Note: Individuals who are not of childbearing potential are exempt from contraceptive requirements. a)IOCBP must have a negative highly sensitive urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin) within 24 hours prior to the start of study intervention. Note: If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive. Note: The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to potentially decrease the risk for inclusion of an individual with an undetected pregnancy. IOCBP must agree to follow instructions for method(s) of contraception as described below and included in the ICF. (1)IOCBP are permitted to use hormonal contraceptive methods (as described in APPENDIX 3). c)A female (as assigned at birth) is eligible to participate if they are not pregnant or breastfeeding and at least 1of the following conditions applies: (1)Is not an IOCBP OR (2)Is an IOCBP and using a contraceptive method that is highly effective (with a failure rate of less than 1 percent per year), preferably with user independent methods, as described in APPENDIX 3, during the intervention period and for at least 16 days after the last dose and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction for the same period. 5)Male (as assigned at birth) participants: 6)Male (as assigned at birth) participants should maintain their usual practi
Exclusion criteria
Exclusion criteria: Participants entering from CN0120036/CN0120037are excluded from the study if any of the following criteria apply: Psychiatric Conditions 1)Discontinuation from any KarXT parent studies. 2)If, in the opinion of the investigator (and/or Sponsor), participant is unsuitable for enrollment in the study or the participant has any finding that, in the view of the investigator (and/or Sponsor), may compromise the safety of the participant or affect their ability to adhere to the protocol visit schedule or fulfill visit requirements. 3)Risk forsuicidal behavior at baseline as determined by the Investigator s clinical assessment, and/or C-SSRS as confirmed by the following: a)Answer Yes on items 4 or 5 (C-SSRS -ideation) since last visit b)Answer Yes to any of the 5 items (C-SSRS behavior) since last visit c)Suicide attempt during the parent study. 4)Risk of violent or destructive behavior. Medical Conditions 5)Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, medical history, vital signs, ECG, or clinical laboratory determinations beyond what is consistent with the target population. Prior/Concomitant Therapy 6)Inability to comply with restrictions and prohibited treatments as listed in Section 7.7: Prior and Concomitant Therapy. 7)Anticipated use of lorazepam greater than 3mg daily for more than 3 times a week during this study. Physical and Laboratory Findings 8)Blood pressure of greater than or equal to 160/100 mmHg (average of triplicate seated measures) at Screening 9)Heart rate of greater than or equal to 110 bpm (average of triplicate seated measures) at Screening De Novo Participantsare excluded from the study if any of the following criteria apply: Psychiatric Conditions 10)Primary diagnosis of BP-I where present mania is first manic episode. 11)Primary diagnosis of BP-I with rapid cycling (ie, greater than or equal too distinct mood episodes in one year). 12)Any primary DSM-5-TR disorder other than BP-I with mania or mania with mixed features within 12 months before Screening (ie, primary focus of treatment, confirmed using MINI version 7.0.2 at Screening) including BP-I with depression, (previous 3 months only), BP-II disorder,major depressive disorder, and primary psychotic disorder, with the exception of mild anxiety disorders. 13)Current manic episode requiringhospitalization. 14)A DSM-5-TR diagnosis of moderate to severe substance use disorder (except tobacco use disorder) within 12 months before Screening (confirmed using MINI version 7.0.2 at Screening), or current use as determined by urine toxicology screen or alcohol test. a)Participants who test positive for cannabis at Screening may be permitted to enroll in consultation with the Medical Monitor if the participant s pattern of use is not indicative of a substance use disorder. 15)Risk for suicidal behavior at Screening as determined by the Investigator s clinical assessment, and/or C-SSRS as confirmed by the following: a)Answer Yes on items 4 or 5 (C-SSRS -ideation) with the most recent episode occurring within 6 months of Screeningorbetween Screening and baselineor,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with treatment emergent adverse events (TEAEs)Timepoint: Up to week 54 | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants with AEs of special interest (AESIs) Number of participants with serious AEs (SAEs) Number of participants with TEAEs leading to treatment discontinuation Number of participants with change in suicidal ideation as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) Change from baseline in Barnes Akathisia Rating Scale (BARS) score Change from baseline in Simpson Angus Scale (SAS) score Change from baseline in Abnormal Involuntary Movement Scale (AIMS) score Change from baseline in International Prostate Symptom Score (IPSS) Timepoint: Up to week 54 Up to week 54 Up to week 52 Up to week 54 Up to week 54 Up to week 54 Up to week 54 Up to week 54 | — |
Countries
Argentina, Australia, Bulgaria, Croatia, Hungary, India, Israel, Italy, Japan, New Zealand, Poland, Romania, Slovakia, Spain, Sweden, United States of America
Contacts
Public ContactShilpi Sinha
Bristol-Myers Squibb India Pvt. Ltd.
Outcome results
None listed