A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-2)

Official title

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-2)

Overview

This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter, inpatient study in participants with bipolar disorder experiencing an acute episode of mania or mania with mixed features. The primary objective of the study is to evaluate the efficacy of KarXT compared to placebo in treating symptoms of mania during a 3-week inpatient period. The duration of the study including screening, the double-blind inpatient treatment period and safety-follow-up is no more than seven weeks.

Interventions

• Drug KarXT
  Specified dose on specified days
• Other Placebo
  Specified dose on specified days

Primary outcome measures

• Change from baseline in Young Mania Rating Scale (YMRS) score [Time frame: At week 3]

Secondary outcome measures (3)

• Change from baseline in Clinical Global Impressions-Bipolar (CGI-BP) [Time frame: At week 3]
• Occurrence of response based on ≥ 50% decrease from baseline in YMRS score or total score [Time frame: At week 3]
• Occurrence of response based on change from baseline ≥ 1 in CGI-BP [Time frame: At week 3]

Eligibility criteria

Inclusion criteria

• Participants must have a primary diagnosis of Bipolar-I disorder established by a comprehensive psychiatric evaluation.
• Participants must be experiencing an acute episode or relapse of mania or mania with mixed features (≤ 3 weeks).
• Participants must require hospitalization for the acute exacerbation or relapse of mania.
• Participants must have all psychotropic medications washed out in no more than 14 days prior to the first dose of the study drug.
• Participants must have a Young Mania Rating Scale (YMRS) score of ≥ 20 at Screening and at Baseline.
• Participants must have a Clinical Global Impressions-Bipolar (CGI-BP) ≥ 4 at Screening and at Baseline.

Exclusion criteria

• Participants must not have any primary Diagnostic and Statistical Manual of Mental Disorders (5th Edition, Text Revision) (DSM-5-TR) disorder, other than BP-I with mania or mania with mixed features within 12 months before screening, including BP-I with depression (for previous 3 months only), BP-II disorder, borderline personality disorder, major depressive disorder, and primary psychotic disorder, with the exception of mild anxiety disorders.
• Participants must not have a primary diagnosis of BP-I with rapid cycling (≥ 4 distinct mood episodes in one year).
• Participants must not have a DSM-5-TR diagnosis of moderate to severe substance use disorder (except tobacco use disorder) within the 12 months before screening, or current use as determined by urine toxicology screen or alcohol test.
• Participants must not be at risk for suicidal behavior at screening or the baseline visit as determined by the Investigator's clinical assessment and the Columbia-Suicide Severity Rating Scale (C-SSRS).
• Participants must not have cirrhosis, liver cancer, clinically significant liver disease based on the liver function test results.
• Other protocol-defined Inclusion/Exclusion criteria apply.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

United States · 28 centers

• Pillar Clinical Research- Little Rock — Little Rock
• Woodland Research Northwest — Rogers
• Proscience Research Group — Culver City
• Clinical Innovations, Inc. dba CITrials — Riverside
• Collaborative Neuroscience Research, LLC — Torrance
• Local Institution - 0036 — Hialeah Gardens
• Behavioral Clinical Research — Hollywood
• LCC Medical Research Institute — Miami
• … and 20 more centers

Romania · 11 centers

• Prof. Dr. Alexandru Obregia Psychiatry Hospital — Bucharest
• Prof. Dr. Alexandru Obregia Psychiatry Hospital — Bucharest
• Prof. Dr. Alexandru Obregia Psychiatry Hospital — Bucharest
• Prof. Dr. Alexandru Obregia Psychiatry Hospital — Bucharest
• Prof. Dr. Alexandru Obregia Psychiatry Hospital — Bucharest
• Prof. Dr. Alexandru Obregia Psychiatry Hospital — Bucharest
• Local Institution - 0097 — Bucharest
• Centrul de Evaluare și Tratament a Toxicodependenței pentru Tineri Sf.Stelian — Bucharest
• … and 3 more centers

India · 8 centers

• GMERS Medical College and General Hospital — Vadodara
• Local Institution - 0082 — Belagavi
• Chethana Center for Neuropsychiatry — Kozhikode
• Dayanand Medical College and Hospital — Ludhiana
• Asha Hospital - Hyderabad — Hyderabad
• Local Institution - 0055 — Hyderabad
• Nil Ratan Sircar Medical College and Hospital — Kolkata
• Local Institution - 0096 — Kolkata

Ukraine · 7 centers

• Local Institution - 0088 — Dnipro
• Local Institution - 0092 — Hlevakha
• … and 5 more centers

China · 6 centers

• Local Institution - 0106 — Wuhu
• Local Institution - 0103 — Beijing
• Local Institution - 0108 — Wuhan
• Local Institution - 0107 — Changsha
• Local Institution - 0105 — Jining Shi
• Local Institution - 0104 — Tianjin

Israel · 6 centers

• Shalvata Mental Health Center — Hod HaSharon
• Ness Ziona Mental Health Center — Ness Ziona
• Local Institution - 0058 — Petah Tikva
• Sheba Medical Center — Ramat Gan
• Be'er Sheva Mental Health Center — Beersheba
• Kfar Shaul Mental Health Center — Jerusalem

Croatia · 5 centers

• Local Institution - 0009 — Zagreb
• Klinika za psihijatriju "Vrapče" — Zagreb
• Klinika za psihijatriju "Vrapče" — Zagreb
• Klinika za psihijatriju "Vrapče" — Zagreb
• Psihijatrijska bolnica "Sveti Ivan" — Zagreb

Italy · 5 centers

• Local Institution - 0001 — Milan
• Local Institution - 0056 — Pisa
• Local Institution - 0007 — Siena
• Local Institution - 0041 — Ancona
• Local Institution - 0040 — Genova

Slovakia · 3 centers

• Local Institution - 0071 — Košice
• Local Institution - 0073 — Košice
• Crystal Comfort — Vranov nad Topľou

Spain · 3 centers

• Local Institution - 0069 — Barcelona
• Local Institution - 0039 — Bilbao
• Local Institution - 0044 — Barcelona

Sweden · 3 centers

• Nacka Local Hospital — Nacka
• Local Institution - 0067 — Uppsala
• Local Institution - 0070 — Gothenburg

Identifiers

NCT: NCT06951711 · CN012-0037 · 2024-520195-94 · U1111-1316-7466

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗