Clinical trial • Phase III • Psychiatry
Trospium chloride; Xanomeline tartrate for Bipolar I disorder | Mania
Phase III trial of Trospium chloride; Xanomeline tartrate for Bipolar I disorder | Mania.
Overview
- Trial Therapeutic Area
- Psychiatry
- Trial Disease
- Bipolar I disorder | Mania
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 10-09-2025
- First CTIS Authorization Date
- 15-01-2026
Trial design
Randomised, placebo (karxt matching placebo) plus background mood stabilizer (lithium, valproate, or lamotrigine); dose/schedule not specified in available documents.-controlled Phase III trial across 25 sites in Denmark, Poland, France and others.
- Randomised
- Yes
- Comparator
- Placebo (KarXT Matching Placebo) plus background mood stabilizer (lithium, valproate, or lamotrigine); dose/schedule not specified in available documents.
- Target Sample Size
- 239
- Trial Duration For Participant
- 35
Eligibility
Recruits 239 No vulnerable populations selected; participants are adults aged 18 to 65 and provide informed consent themselves. No assent procedures for minors are described..
- Vulnerable Population
- No vulnerable populations selected; participants are adults aged 18 to 65 and provide informed consent themselves. No assent procedures for minors are described.
Inclusion criteria
- {"criterion_text":"- Participant must be 18 to 65 years of age, inclusive, at the time of signing the ICF."}
- {"criterion_text":"- Individuals have a primary diagnosis of Bipolar-I disorder established by a comprehensive psychiatric evaluation based on the DSM-5-TR criteria and confirmed by the Mini International Neuropsychiatric Interview (MINI) version 7.0.2 Standard with Borderline Personality Disorder version."}
- {"criterion_text":"- Individual is experiencing an acute exacerbation or relapse of manic episode, with or without mixed features (≤ 3 weeks)."}
- {"criterion_text":"- The individual requires hospitalization for the acute exacerbation or relapse of mania."}
- {"criterion_text":"- Body mass index ≥ 18 and ≤ 40 kg/m2"}
- {"criterion_text":"- Currently experiencing an acute episode of mania or mania with mixed features with a therapeutic dose of lithium, valproate, or lamotrigine. The dose of the mood stabilizer must have remained stable for at least two weeks prior to screening. Additionally, participants on valproate must have been receiving treatment with valproate for a minimum of seven months."}
- {"criterion_text":"- YMRS Total Score of ≥ 18 at Screening and at Baseline, and < 20% reduction in YMRS from screening to baseline."}
- {"criterion_text":"- Clinical Global Impression Severity scale (CGI-BP) ≥ 4"}
Exclusion criteria
- {"criterion_text":"- Any primary DSM-5-TR disorder other than BP-I within 12 months before screening (confirmed using MINI version 7.0.2 Standard with Borderline Personality Disorder version at screening) including BP-I depression, BP-I with rapid cycling, first manic episode, BP-II, borderline personality disorder, and major depressive disorder."}
- {"criterion_text":"- 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 Standard with Borderline Personality Disorder version at screening), or current use as determined by urine toxicology screen or alcohol test."}
- {"criterion_text":"- Risk for suicidal behavior at screening as determined by the investigator’s clinical assessment and the C-SSRS with an answer “Yes” to item 4 or 5 within 6 months before screening or between screening and baseline, or suicide attempt within 12 months before screening, or between screening and baseline"}
- {"criterion_text":"- History of irritable bowel syndrome (with or without constipation) or any serious constipation requiring treatment within the last 6 months."}
- {"criterion_text":"- History or high risk of urinary retention, gastric retention, or narrow-angle glaucoma."}
- {"criterion_text":"- Participants with HIV, cirrhosis, biliary duct abnormalities, hepatobiliary carcinoma, and/or active hepatic viral infections based on either medical history or the LFT results."}
- {"criterion_text":"- Elevations in hepatic transaminases at screening ≥ 2 × ULN for ALT and AST and/or bilirubin > 1.5× ULN, unless in the context of Gilbert’s syndrome."}
- {"criterion_text":"- All grades of hepatic impairment (mild [Child-Pugh Class A], moderate [Child-Pugh Class B], and severe [Child-Pugh Class C])."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Change from baseline in Young Mania Rating Scale (YMRS, used to evaluate manic symptoms) score at Week 5.","definition_or_measurement_approach":"Change from baseline in YMRS score at Week 5; YMRS is used to evaluate manic symptoms."}
Secondary endpoints
- {"endpoint_text":"- Change from baseline in CGI-BP (used to evaluate daily functioning) at Week 5.","definition_or_measurement_approach":"Change from baseline in CGI-BP score at Week 5; CGI-BP used to evaluate daily functioning."}
Recruitment
- Planned Sample Size
- 239
- Recruitment Window Months
- 17
- Consent Approach
- Participants (adults aged 18–65) provide written informed consent (ICF). Subject information and informed consent forms are available in multiple language versions (documents listed in English, Polish, French, Italian, Bulgarian and Romanian among others). Specialized ICFs are provided for topics such as pregnant partner/participant and optional biomarker/future research; no assent procedures for minors are described.
Geography
- Total Number Of Sites
- 25
- Total Number Of Participants
- 185
Denmark
- Earliest CTIS Part Ii Submission Date
- 12-12-2025
- Latest Decision Or Authorization Date
- 15-01-2026
- Processing Time Days
- 34
- Number Of Sites
- 2
- Number Of Participants
- 18
Sites
- Site Name
- Region Nordjylland
- Department Name
- Department of Psychiatry
- Principal Investigator Name
- René Ernst Nielsen
- Principal Investigator Email
- ren@rn.dk
- Contact Person Name
- René Ernst Nielsen
- Contact Person Email
- ren@rn.dk
- Site Name
- Region Hovedstadens Psykiatriske
- Department Name
- Mental Health Center Glostrup
- Principal Investigator Name
- Bjørn H. Ebdrup
- Principal Investigator Email
- bjoern.ebdrup@regionh.dk
- Contact Person Name
- Bjørn H. Ebdrup
- Contact Person Email
- bjoern.ebdrup@regionh.dk
Poland
- Earliest CTIS Part Ii Submission Date
- 16-12-2025
- Latest Decision Or Authorization Date
- 19-01-2026
- Processing Time Days
- 34
- Number Of Sites
- 5
- Number Of Participants
- 35
Sites
- Site Name
- Inventiva Biomedical And Research Sp. z o.o.
- Department Name
- -
- Principal Investigator Name
- Jarosław Strzelec
- Principal Investigator Email
- jarek35a@hotmail.com
- Contact Person Name
- Jarosław Strzelec
- Contact Person Email
- jarek35a@hotmail.com
- Site Name
- M2M Med. Sp. z o.o. Sp. j.
- Department Name
- -
- Principal Investigator Name
- Wojciech Eysymontt
- Principal Investigator Email
- w.eysymontt@m2m-badania.pl
- Contact Person Name
- Wojciech Eysymontt
- Contact Person Email
- w.eysymontt@m2m-badania.pl
- Site Name
- Uniwersyteckie Centrum Kliniczne
- Department Name
- Klinika Psychiatrii Dorosłych
- Principal Investigator Name
- Wiesław Cubala
- Principal Investigator Email
- cubala@gumed.edu.pl
- Contact Person Name
- Wiesław Cubala
- Contact Person Email
- cubala@gumed.edu.pl
- Site Name
- Uniwersytecki Szpital Kliniczny W Bialymstoku
- Department Name
- Klinika Psychiatry
- Principal Investigator Name
- Napoleon Waszkiewicz
- Principal Investigator Email
- napwas@wp.pl
- Contact Person Name
- Napoleon Waszkiewicz
- Contact Person Email
- napwas@wp.pl
- Site Name
- Instytut Psychiatrii I Neurologii
- Department Name
- II Klinika Psychiatryczna
- Principal Investigator Name
- Adam Wichniak
- Principal Investigator Email
- wichniak@ipin.edu.pl
- Contact Person Name
- Adam Wichniak
- Contact Person Email
- wichniak@ipin.edu.pl
France
- Earliest CTIS Part Ii Submission Date
- 17-10-2025
- Latest Decision Or Authorization Date
- 19-01-2026
- Processing Time Days
- 94
- Number Of Sites
- 1
- Number Of Participants
- 15
Sites
- Site Name
- CHU Gabriel-Montpied
- Department Name
- Psychiatrie Adulte
- Principal Investigator Name
- Pierre-Michel LLORCA
- Principal Investigator Email
- pmllorca@chu-clermontferrand.fr
- Contact Person Name
- Pierre-Michel LLORCA
- Contact Person Email
- pmllorca@chu-clermontferrand.fr
Italy
- Earliest CTIS Part Ii Submission Date
- 10-11-2025
- Latest Decision Or Authorization Date
- 16-01-2026
- Processing Time Days
- 67
- Number Of Sites
- 5
- Number Of Participants
- 25
Sites
- Site Name
- IRCCS Ospedale Policlinico San Martino
- Department Name
- Department of Psychiatry
- Principal Investigator Name
- Gianluca Serafini
- Principal Investigator Email
- Gianluca.Serafini@unige.it
- Contact Person Name
- Gianluca Serafini
- Contact Person Email
- Gianluca.Serafini@unige.it
- Site Name
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
- Department Name
- Psichiatria
- Principal Investigator Name
- Paolo Brambilla
- Principal Investigator Email
- paolo.brambilla@policlinico.mi.it
- Contact Person Name
- Paolo Brambilla
- Contact Person Email
- paolo.brambilla@policlinico.mi.it
- Site Name
- Azienda Ospedaliero-Universitaria Senese
- Department Name
- UOC Psichiatria Universitaria
- Principal Investigator Name
- Andrea Fagiolini
- Principal Investigator Email
- andrea.fagiolini@unisi.it
- Contact Person Name
- Andrea Fagiolini
- Contact Person Email
- andrea.fagiolini@unisi.it
- Site Name
- Azienda Ospedaliero Universitaria Pisana
- Department Name
- UO Psichiatria
- Principal Investigator Name
- Giulio Perugi
- Principal Investigator Email
- giulio.perugi@med.unipi.it
- Contact Person Name
- Giulio Perugi
- Contact Person Email
- giulio.perugi@med.unipi.it
- Site Name
- Azienda Ospedaliero Universitaria Delle Marche
- Department Name
- SOD Clinica Psichiatrica
- Principal Investigator Name
- Umberto Volpe
- Principal Investigator Email
- u.volpe@univpm.it
- Contact Person Name
- Umberto Volpe
- Contact Person Email
- u.volpe@univpm.it
Romania
- Earliest CTIS Part Ii Submission Date
- 26-11-2025
- Latest Decision Or Authorization Date
- 19-01-2026
- Processing Time Days
- 54
- Number Of Sites
- 10
- Number Of Participants
- 72
Sites
- Site Name
- Centru De Evaluare Si Tratament A Toxicodependentelor Pentru Tineri Sf. Stelian
- Department Name
- Neurology
- Principal Investigator Name
- Traian Liciniu Barbu
- Principal Investigator Email
- trabar98@yahoo.com
- Contact Person Name
- Traian Liciniu Barbu
- Contact Person Email
- trabar98@yahoo.com
- Site Name
- Spitalul Clinic De Psihiatrie Si Neurologie Brasov
- Department Name
- Neurology
- Principal Investigator Name
- Petru Iftenie
- Principal Investigator Email
- petru_ifteni@yahoo.com
- Contact Person Name
- Petru Iftenie
- Contact Person Email
- petru_ifteni@yahoo.com
- Site Name
- Institutul Național de Gerontologie și Geriatrie "Ana Aslan"
- Department Name
- Neurology
- Principal Investigator Name
- Traian Purnichi
- Principal Investigator Email
- traian.purnichi@gmail.com
- Contact Person Name
- Traian Purnichi
- Contact Person Email
- traian.purnichi@gmail.com
- Site Name
- Spitalul Clinic de Psihiatrie "Profesor Dr. Alexandru Obregia"
- Department Name
- Neurology
- Principal Investigator Name
- Valentin Matei
- Principal Investigator Email
- valipmatei@yahoo.com
- Contact Person Name
- Valentin Matei
- Contact Person Email
- valipmatei@yahoo.com
- Site Name
- Spitalul Universitar De Urgenta Militar Central Dr. Carol Davila
- Department Name
- Neurology
- Principal Investigator Name
- Octavian Vasiliu
- Principal Investigator Email
- octavvasiliu@yahoo.com
- Contact Person Name
- Octavian Vasiliu
- Contact Person Email
- octavvasiliu@yahoo.com
- Site Name
- Spitalul Clinic De Psihiatrie Prof.Dr.Alexandru Obregia
- Department Name
- Neurology
- Principal Investigator Name
- Laura Cristina Dolis
- Principal Investigator Email
- drcristinadolis@gmail.com
- Contact Person Name
- Laura Cristina Dolis
- Contact Person Email
- drcristinadolis@gmail.com
- Site Name
- Spitalul Clinic De Psihiatrie Prof.Dr.Alexandru Obregia
- Department Name
- Neurology
- Principal Investigator Name
- Cristinel Stefanescu
- Principal Investigator Email
- cristinel.stefanescu@gmail.com
- Contact Person Name
- Cristinel Stefanescu
- Contact Person Email
- cristinel.stefanescu@gmail.com
- Site Name
- Spitalul Clinic De Psihiatrie Prof.Dr.Alexandru Obregia
- Department Name
- Neurology
- Principal Investigator Name
- Adela Ciobanu
- Principal Investigator Email
- adela.ciobanu@yahoo.com
- Contact Person Name
- Adela Ciobanu
- Contact Person Email
- adela.ciobanu@yahoo.com
- Site Name
- Spitalul Clinic De Psihiatrie Prof.Dr.Alexandru Obregia
- Department Name
- Neurology
- Principal Investigator Name
- Mihnea Manea
- Principal Investigator Email
- maneamihnea@gmail.com
- Contact Person Name
- Mihnea Manea
- Contact Person Email
- maneamihnea@gmail.com
- Site Name
- Institutul De Psihiatrie Socola Iasi
- Department Name
- Neurology
- Principal Investigator Name
- Cristinel Stefanescu
- Principal Investigator Email
- cristinel.stefanescu@gmail.com
- Contact Person Name
- Cristinel Stefanescu
- Contact Person Email
- cristinel.stefanescu@gmail.com
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 15-12-2025
- Latest Decision Or Authorization Date
- 16-02-2026
- Processing Time Days
- 63
- Number Of Sites
- 2
- Number Of Participants
- 20
Sites
- Site Name
- University Multiprofile Hospital For Active Treatment Dr. Georgi Stranski EAD
- Department Name
- First Psychiatric Clinic-Psychiatry Level III
- Principal Investigator Name
- Maya Stoimenova-Popova
- Principal Investigator Email
- umbal@umbalpln.com
- Contact Person Name
- Maya Stoimenova-Popova
- Contact Person Email
- umbal@umbalpln.com
- Site Name
- State Psychiatric Saint Ivan Rilski Hospital
- Department Name
- Department of General Psyhiatry-closed type for adult-men Department of General Psyhiatry-closed ty
- Principal Investigator Name
- Tsveteslava Galabova
- Principal Investigator Email
- account_kurilo@abv.bg
- Contact Person Name
- Tsveteslava Galabova
- Contact Person Email
- account_kurilo@abv.bg
Sponsor
Primary sponsor
- Full Name
- Bristol-Myers Squibb Services Unlimited Company
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Ireland
Contract research organisations
- Name
- Iqvia Holdings Inc.
- Responsibilities
- Site Payments
- Name
- Syneos Health Inc.
- Responsibilities
- Subject eligbility review/Medical monitoring
- Name
- Medidata Solutions Inc.
- Responsibilities
- Data Management Platform
- Name
- Accenture Solutions Private Limited
- Responsibilities
- Embarc operations; Pharmacovigilance duties: Medical review and Cases Data Entry
Third parties
- {"country":"India","full_name":"Accenture Solutions Private Limited","duties_or_roles":"Embarc operations","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"Data Management Platform","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Iqvia Holdings Inc.","duties_or_roles":"Site Payments","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"Subject eligbility review/Medical monitoring","organisation_type":"Pharmaceutical company"}
- {"country":"India","full_name":"Accenture Solutions Private Limited","duties_or_roles":"Pharmacovigilance duties: Medical review and Cases Data Entry","organisation_type":"Pharmaceutical company"}
- {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"Central Lab","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Empatica Inc.","duties_or_roles":"Digital biomarker device and software","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"eCOA rater station development, eCOA data review, PRO/COA licensing and translations; Rater training","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Provides electronic payments, travel arrangements,electronic study-related comunications to patients","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Labcorp","duties_or_roles":"Specialty Biomarker Testing Lab for HLA Alleles","organisation_type":"Laboratory/Research/Testing facility"}
Investigational products
- Investigational Product Name
- KarXT
- Active Substance
- Trospium chloride; Xanomeline tartrate
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- Oral
- Authorisation Status
- Authorised (prodAuthStatus 1)
- Investigational Product Name
- KarXT Matching Placebo
- Modality
- Other
- Combination Treatment
- Yes
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