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

Phase 3

Not yet recruiting

• Conditions: Bipolar Disorder Type I With Mania
• Interventions: Drug: KarXT

• Registration Number: NCT06929273
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-04-14
• Study First Submitted QC: 2025-04-14
• Study First Posted: 2025-04-16
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-02
• Last Update Posted: 2025-05-05
• Study Start: 2025-07-22
• Primary Completion: 2028-06-13
• Study Completion: 2028-06-13

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Participants who participated in double-blind placebo-controlled study (CN0120036 or CN0120037):

  a. Participants must have completed treatment period of parent study.

• De novo participants who did not participate in double-blind placebo-controlled studies:

  1. Participants must have primary diagnosis of Bipolar-I disorder established by a comprehensive psychiatric evaluation based on DSM-5-TR criteria and confirmed by the Mini International Neuropsychiatric Interview (MINI, v7.0.2), with symptoms of mania or mixed mania.
  2. Participants must have Young Mania Rating Scale (YMRS) score of ≥ 14 at Screening and at baseline.
  3. Participants must have CGI-BP score of ≥ 3 at Screening and at baseline.
  4. Participants does not require hospitalization for acute mania.

Exclusion Criteria

• Participants who participated in double-blind placebo-controlled study (CN0120036 or CN0120037):

  a. Discontinuation from any KarXT parent studies.

• De novo participants who did not participate in double-blind placebo-controlled studies:

  1. 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.
  2. Participants must not have primary diagnosis of BP-I with rapid cycling (ie, ≥ 4 distinct mood episodes in one year).
  3. Participants must not have any primary DSM-5-TR disorder other than BP-I with mania or mania with mixed features within 12 months before Screening (confirmed using MINI version 7.0.2 at Screening), including BP-I with depression, (previous 3 months only), Bipolar-II disorder, major depressive disorder, and primary psychotic disorder, with the exception of mild anxiety disorders.
  4. Individual has a DSM-5-TR diagnosis of moderate to severe substance use disorder (except tobacco use disorder) within the 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.
  5. Participants must not have history of irritable bowel syndrome (with or without constipation) or serious constipation requiring treatment within the last 6 months.
  6. Participants must not have history or high risk of urinary retention, gastric retention, or untreated narrow-angle glaucoma.
  7. Other protocol-defined Inclusion/Exclusion criteria apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
KarXT	KarXT	-

Primary Outcome Measures

Name	Time	Method
Number of participants with treatment emergent adverse events (TEAEs)	Up to week 54

Secondary Outcome Measures

Name	Time	Method
Number of participants with AEs of special interest (AESIs)	Up to week 54
Number of participants with serious AEs (SAEs)	Up to week 54
Number of participants with TEAEs leading to treatment discontinuation	Up to week 54
Number of participants with change in suicidal ideation as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)	Up to week 54
Change from baseline in Barnes Akathisia Rating Scale (BARS) score	Up to week 54
Change from baseline in Simpson Angus Scale (SAS) score	Up to week 54
Chnage from baseline in Abnormal Involuntary Movement Scale (AIMS) score	Up to week 54
Change from baseline in International Prostate Symptom Score (IPSS)	Up to week 54	Only for males ≥ 45 years of age

Trial Locations

Locations (119)

Local Institution - 0113; 🇧🇬 Sliven, Bulgaria

Local Institution - 0120; 🇺🇸 Glendale, Arizona, United States

Local Institution - 0123; 🇺🇸 Torrance, California, United States

Local Institution - 0059; 🇺🇸 Hollywood, Florida, United States

Local Institution - 0053; 🇺🇸 Hollywood, Florida, United States

Local Institution - 0121; 🇺🇸 North Las Vegas, Nevada, United States

Local Institution - 0122; 🇺🇸 North Las Vegas, Nevada, United States

Local Institution - 0124; 🇺🇸 Charlotte, North Carolina, United States

Local Institution - 0119; 🇸🇰 Košice, Košický Kraj, Slovakia

Local Institution - 0125; 🇸🇪 Nacka, Stockholms Län [se-01], Sweden

Local Institution - 0022; 🇺🇸 Bentonville, Arkansas, United States

Local Institution - 0021; 🇺🇸 Little Rock, Arkansas, United States

Local Institution - 0038; 🇺🇸 Little Rock, Arkansas, United States

Local Institution - 0057; 🇺🇸 Rogers, Arkansas, United States

Local Institution - 0027; 🇺🇸 Anaheim, California, United States

Local Institution - 0044; 🇺🇸 Cerritos, California, United States

Local Institution - 0037; 🇺🇸 Culver City, California, United States

Local Institution - 0085; 🇺🇸 Garden Grove, California, United States

Local Institution - 0056; 🇺🇸 Montclair, California, United States

Local Institution - 0039; 🇺🇸 Orange, California, United States

Local Institution - 0043; 🇺🇸 Riverside, California, United States

Local Institution - 0050; 🇺🇸 Santa Ana, California, United States

Local Institution - 0026; 🇺🇸 Hialeah Gardens, Florida, United States

Local Institution - 0047; 🇺🇸 Miami Lakes, Florida, United States

Local Institution - 0025; 🇺🇸 Miami Springs, Florida, United States

Local Institution - 0030; 🇺🇸 Miami, Florida, United States

Local Institution - 0028; 🇺🇸 Miami, Florida, United States

Local Institution - 0045; 🇺🇸 Saint Petersburg, Florida, United States

Local Institution - 0032; 🇺🇸 Stuart, Florida, United States

Local Institution - 0052; 🇺🇸 Atlanta, Georgia, United States

Local Institution - 0054; 🇺🇸 Atlanta, Georgia, United States

Local Institution - 0023; 🇺🇸 Decatur, Georgia, United States

Local Institution - 0024; 🇺🇸 Savannah, Georgia, United States

Local Institution - 0031; 🇺🇸 Chicago, Illinois, United States

Local Institution - 0020; 🇺🇸 Chicago, Illinois, United States

Local Institution - 0049; 🇺🇸 Gaithersburg, Maryland, United States

Local Institution - 0029; 🇺🇸 Flowood, Mississippi, United States

Local Institution - 0042; 🇺🇸 Saint Louis, Missouri, United States

Local Institution - 0058; 🇺🇸 Marlton, New Jersey, United States

Local Institution - 0033; 🇺🇸 Staten Island, New York, United States

Local Institution - 0055; 🇺🇸 Cincinnati, Ohio, United States

Local Institution - 0040; 🇺🇸 North Canton, Ohio, United States

Local Institution - 0048; 🇺🇸 DeSoto, Texas, United States

Local Institution - 0046; 🇺🇸 Houston, Texas, United States

Local Institution - 0036; 🇺🇸 Irving, Texas, United States

Local Institution - 0034; 🇺🇸 Richardson, Texas, United States

Local Institution - 0105; 🇦🇺 St Leonards, New South Wales, Australia

Local Institution - 0087; 🇦🇺 Brisbane, Queensland, Australia

Local Institution - 0082; 🇧🇬 Burgas, Bulgaria

Local Institution - 0107; 🇧🇬 Novi Iskar, Bulgaria

Local Institution - 0081; 🇧🇬 Pleven, Bulgaria

Local Institution - 0114; 🇧🇬 Vratsa, Bulgaria

Local Institution - 0018; 🇭🇷 Zagreb, Grad Zagreb, Croatia

Local Institution - 0017; 🇭🇷 Zagreb, Croatia

Local Institution - 0019; 🇭🇷 Zagreb, Croatia

Local Institution - 0103; 🇭🇷 Zagreb, Croatia

Local Institution - 0109; 🇭🇺 Győr, Győr-Moson-Sopron, Hungary

Local Institution - 0110; 🇭🇺 Budapest, Hungary

Local Institution - 0108; 🇭🇺 Budapest, Hungary

Local Institution - 0111; 🇮🇳 Vadodara, Gujarat, India

Local Institution - 0079; 🇮🇳 Kozhikode, Kerala, India

Local Institution - 0078; 🇮🇳 Hyderabad, Telangana, India

Local Institution - 0080; 🇮🇳 Hyderabad, Telangana, India

Local Institution - 0076; 🇮🇳 Kolkata, West Bengal, India

Local Institution - 0077; 🇮🇳 Ludhiana, India

Local Institution - 0106; 🇮🇱 Be'er Sheva, HaDarom, Israel

Local Institution - 0068; 🇮🇱 Hod HaSharon, HaMerkaz, Israel

Local Institution - 0075; 🇮🇱 Ness Ziona, HaMerkaz, Israel

Local Institution - 0084; 🇮🇱 Petah Tikva, HaMerkaz, Israel

Local Institution - 0067; 🇮🇱 Ramat Gan, HaMerkaz, Israel

Local Institution - 0074; 🇮🇱 Jerusalem, Yerushalayim, Israel

Local Institution - 0066; 🇮🇹 Milano, Lombardia, Italy

Local Institution - 0083; 🇮🇹 Pisa, Toscana, Italy

Local Institution - 0065; 🇮🇹 Siena, Toscana, Italy

Local Institution - 0070; 🇮🇹 Ancona, Italy

Local Institution - 0069; 🇮🇹 Genova, Italy

Local Institution - 0008; 🇯🇵 Konan, Aichi, Japan

Local Institution - 0003; 🇯🇵 Toyoake, Aichi, Japan

Local Institution - 0001; 🇯🇵 Ichikawa, Chiba, Japan

Local Institution - 0063; 🇯🇵 Kitakyushu, Fukuoka, Japan

Local Institution - 0015; 🇯🇵 Obihiro, Hokkaido, Japan

Local Institution - 0005; 🇯🇵 Sapporo, Hokkaido, Japan

Local Institution - 0007; 🇯🇵 Sakai-shi, Osaka, Japan

Local Institution - 0011; 🇯🇵 Karatsu-shi, Saga-Ken, Japan

Local Institution - 0016; 🇯🇵 Iruma, Saitama, Japan

Local Institution - 0012; 🇯🇵 Kumagaya, Saitama, Japan

Local Institution - 0009; 🇯🇵 Itabashi City, Tokyo, Japan

Local Institution - 0072; 🇯🇵 Kodaira, Tokyo, Japan

Local Institution - 0006; 🇯🇵 Fukuoka, Japan

Local Institution - 0004; 🇯🇵 Miyazaki, Japan

Local Institution - 0010; 🇯🇵 Osaka, Japan

Local Institution - 0013; 🇯🇵 Osaka, Japan

Local Institution - 0073; 🇯🇵 Tokyo, Japan

Local Institution - 0002; 🇯🇵 Wakayama, Japan

Local Institution - 0014; 🇯🇵 Yamagata, Japan

Local Institution - 0086; 🇳🇿 Auckland, New Zealand

Local Institution - 0092; 🇵🇱 Warsaw, Mazowieckie, Poland

Local Institution - 0090; 🇵🇱 Bialystok, Podlaskie, Poland

Local Institution - 0093; 🇵🇱 Gdańsk, Pomorskie, Poland

Local Institution - 0088; 🇵🇱 Poznań, Wielkopolskie, Poland

Local Institution - 0091; 🇵🇱 Tuszyn, Łódzkie, Poland

Local Institution - 0089; 🇵🇱 Chorzów, Śląskie, Poland

Local Institution - 0100; 🇷🇴 Brașov, Brăila, Romania

Local Institution - 0095; 🇷🇴 Bucharest, București, Romania

Local Institution - 0096; 🇷🇴 Bucharest, București, Romania

Local Institution - 0098; 🇷🇴 Bucharest, București, Romania

Local Institution - 0099; 🇷🇴 Bucharest, București, Romania

Local Institution - 0101; 🇷🇴 Bucharest, București, Romania

Local Institution - 0102; 🇷🇴 Bucharest, București, Romania

Local Institution - 0104; 🇷🇴 Bucharest, București, Romania

Local Institution - 0094; 🇷🇴 București, Romania

Local Institution - 0097; 🇷🇴 Iași, Romania

Local Institution - 0118; 🇸🇰 Kosice, Košický Kraj, Slovakia

Local Institution - 0117; 🇸🇰 Vranov nad Topľou, Prešovský Kraj, Slovakia

Local Institution - 0115; 🇪🇸 Barcelona, Barcelona [Barcelona], Spain

Local Institution - 0071; 🇪🇸 Barcelona, Catalunya [Cataluña], Spain

Local Institution - 0064; 🇪🇸 Bilbo, País Vasco, Spain

Local Institution - 0112; 🇸🇪 Uppsala, Uppsala Län [se-03], Sweden

Local Institution - 0116; 🇸🇪 Gothenburg, Västra Götalands Län [se-14], Sweden