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

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-1)

Overview

The purpose of this study is to evaluate the efficacy and safety of KarXT for the treatment of manic episodes in Bipolar-I Disorder

Detailed description

This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter, inpatient study in subjects 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 a ≥ 50% decrease from baseline in YMRS total score [Time frame: At week 3]
• Occurrence of response based on CGI-BP change from baseline ≥ 1 [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 a history of irritable bowel syndrome (with or without constipation) or serious constipation requiring treatment within the last 6 months.
• Participants must not have a history or high risk of urinary retention, gastric retention, or untreated narrow-angle glaucoma.
• 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 · 22 centers

• Local Institution - 0058 — Bentonville
• Woodland International Research Group — Little Rock
• Advanced Research Center Inc. — Anaheim
• CITrials — Bellflower
• Local Institution - 0014 — Cerritos
• Collaborative Neuroscience Research, LLC — Long Beach
• NRC Research Institute — Los Angeles
• Catalina Research Institute, LLC — Montclair
• … and 14 more centers

Japan · 19 centers

• Hotei Hospital — Kōnan
• Okehazama Hospital — Toyoake
• National Kohnodai Medical Center. — Ichikawa
• Local Institution - 0100 — Kitakyushu
• Obihiro Kosei Hospital — Obihiro
• Goryokai Medical Corporation - Goryokai Hospital — Sapporo
• Kansai Medical University Medical Center — Moriguchi
• Rainbow and Sea Hospital — Karatsu-shi
• … and 11 more centers

Bulgaria · 7 centers

• Local Institution - 0138 — Kazanlak
• Center for Mental Health Prof. Dr. Ivan Temkov — Burgas
• Local Institution - 0139 — Haskovo
• State Psychiatric Hospital Sv. Ivan Rilski Novi Iskar — Novi Iskar
• "University Multiprofile Hospital for Active Treatment - Dr. Georgi Stranski" EAD — Pleven
• MHAT "Dr. Ival Seliminski" — Sliven
• Mental Health Center - Vratsa — Vratsa

Poland · 7 centers

• Centrum Medyczne HCP — Poznan
• Instytut Psychiatrii i Neurologii — Warsaw
• Klinika Psychiatrii Uniwersytet Medyczny w Białymstoku — Bialystok
• Local Institution - 0111 — Gdansk
• M2M Med — Rybnik
• Local Institution - 0102 — Sosnowiec
• Clinica Inventiva — Tuszyn

Ukraine · 7 centers

• Local Institution - 0131 — Smila
• Local Institution - 0133 — Skarzhyntsi
• Local Institution - 0130 — Dnipro
• Local Institution - 0126 — Kropyvnytskyi
• Local Institution - 0129 — Kyiv
• Local Institution - 0132 — Poltava
• Local Institution - 0137 — Ternopil

Argentina · 5 centers

• Hospital Italiano de Buenos Aires — ABB
• Clinica del Prado — Las Heras
• Sanatorio Morra S.A. — Córdoba
• Local Institution - 0109 — Mendoza
• Local Institution - 0140 — Santiago del Estero

Hungary · 3 centers

• Petz Aladar Egyetemi Oktato Korhaz — Győr
• Semmelweis Egyetem — Budapest
• Local Institution - 0114 — Budapest

Australia · 2 centers

• Ramsay Clinic Northside — St Leonards
• Ramsay Clinic New Farm — Brisbane

New Zealand · 1 center

• North Shore Hospital — Auckland

Identifiers

NCT: NCT06951698 · CN012-0036 · 2024-520165-32 · U1111-1316-7438

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗