SchizophreniaPhase 3NCT07424404

A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents

A Phase 3 study testing KarXT and KarX-EC in people with Schizophrenia and Autism-Related Irritability, run by Karuna Therapeutics, Inc., a Bristol Myers Squibb company at 104 sites in 11 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

Search all trials

Trial summary

The purpose of this study is to evaluate the long-term safety and tolerability of Xanomeline and Trospium Chloride for the treatment of psychiatric disorders in children and adolescents Read more about this study

Who is it for?: Ages 5 to 17 years
Conditions the study is for: Schizophrenia, Autism-Related Irritability
What is being tested?: KarXT and KarX-EC
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 400 participants
Where: 104 sitesin 11 countries
Study dates: 7 Apr 2026to 8 Mar 2030
Phase: Phase 3
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 5 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

Participants must have completed the double-blind treatment period (ie, Visit 8) of Study CN0120020 or the double-blind treatment period (ie, Week 8) of Study CN0120044 or CN0120045 without an adverse event (AE) that, in the opinion of the investigator, may indicate an unacceptable safety risk.
De-novo participants must have confirmed diagnosis of ASD with symptoms of irritability, as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria, confirmed by the Kiddie Schedule for Affective Disorders and Schizophrenia-Present and Lifetime version (K-SADS-PL).

Who cannot join

Participants must not have a significant risk of committing violent acts, serious self-harm, or attempting suicide based on history or routine psychiatric status examination, or those who are homicidal or are considered to be a high risk to others, or who have an answer of "Yes" on Questions 4 or 5 on the suicidal ideation section of the "Since Last Visit" version of the C-SSRS at baseline (Visit 1). Nonsuicidal, self-injurious behavior is not exclusionary.
Participants must not have any clinically significant abnormality including any finding(s) from the physical examination, vital signs, or ECG at the end of treatment visit of Study CN0120020, CN0120044 or CN00120045 that the investigator, in consultation with the Sponsor Medical Monitor, would jeopardize the safety of the participant.
Participants must not have either a systolic blood pressure (sBP) or diastolic blood pressure (dBP) meeting criteria for stage 2 hypertension (HTN), regardless of the presence or absence of symptoms.
Other protocol-defined Inclusion/Exclusion criteria apply.

Trial locations and contacts

104 sites in 11 countries. Contact the study team or a site near you to ask about taking part.

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact

855-907-3286

Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #. contact

Country

City, postcode or hospital

Sites recruiting now only

104 sites in 11 countries

United States56 sites, 54 recruiting

Advanced Research Center Inc.
Anaheim, California, 92805
Steven Macina, Site 0077, 714-999-6688
Recruiting
Local Institution - 0159
Anaheim, California, 92805
Site 0159
Not yet recruiting
Atlanta Center for Medical Research
Atlanta, Georgia, 30331
Elyssa Barron, Site 0057, 404-881-5800
Recruiting
Local Institution - 0152
Bloomfield Hills, Michigan, 48302
Site 0152
Not yet recruiting
Local Institution - 0145
Boca Raton, Florida, 33428
Site 0145
Not yet recruiting
Boston Children's Hospital
Boston, Massachusetts, 02445
Joseph Gonzalez-Heydrich, Site 0076
Recruiting
Local Institution - 0175
Chicago, Illinois, 60611
Site 0175
Not yet recruiting
EmVenio Research Center - Prime Healthcare
Chicago, Illinois, 60622
Mitchell Glaser, Site 0044, 773-620-2995
Recruiting
Inland Psychiatric Medical Group.
Chino, California, 91710
Nandita Puchakayala, Site 0058, 909-488-9116
Recruiting
University of Cincinnati Cancer Institute
Cincinnati, Ohio, 45219
Melissa DelBello, Site 0051
Recruiting
Local Institution - 0148
Cincinnati, Ohio, 45229
Site 0148
Not yet recruiting
Local Institution - 0142
Columbia, Missouri, 65201
Site 0142
Not yet recruiting
Proscience Research Group
Culver City, California, 90230
Marina Bussel, Site 0024, 424-227-8127
Recruiting
Local Institution - 0149
Dallas, Texas, 75243
Site 0149
Not yet recruiting
Local Institution - 0143
Danville, Pennsylvania, 17821
Site 0143
Not yet recruiting
Local Institution - 0173
Decatur, Georgia, 30030
Site 0173
Not yet recruiting
Local Institution - 0054
Dothan, Alabama, 36303
Site 0054
Not yet recruiting
Local Institution - 0155
Everett, Washington, 98201
Site 0155
Not yet recruiting
Local Institution - 0160
Gainesville, Florida, 32607
Site 0160
Not yet recruiting
Local Institution - 0164
Gainesville, Florida, 32607
Site 0164
Not yet recruiting
VAST Clinical Research
Garland, Texas, 75043
Asikaiwe Chima, Site 0046
Recruiting
Local Institution - 0162
Glendale, California, 91203
Site 0162
Not yet recruiting
Local Institution - 0061
Great Neck, New York, 11021
Site 0061
Not yet recruiting
Local Institution - 0168
Hollywood, Florida, 33024
Site 0168
Not yet recruiting
Evolution Research Group
Houston, Texas, 77043
Carlin Barnes, Site 0169
Recruiting
Local Institution - 0047
Houston, Texas, 77090
Site 0047
Not yet recruiting
Local Institution - 0144
Las Vegas, Nevada, 89128
Site 0144
Not yet recruiting
Salveo Integrative Health - Lawrenceville
Lawrenceville, Georgia, 30046
Shahzad Hashmi, Site 0103
Recruiting
Local Institution - 0132
Lexington, Massachusetts, 02421
Site 0132
Not yet recruiting
Local Institution - 0147
Lincoln, Nebraska, 68526
Site 0147
Not yet recruiting
Local Institution - 0153
Los Angeles, California, 90095
Site 0153
Not yet recruiting
Local Institution - 0170
Louisville, Kentucky, 40202
Site 0170
Not yet recruiting
Local Institution - 0137
Nashville, Tennessee, 37212
Site 0137
Not yet recruiting
Local Institution - 0146
Neptune City, New Jersey, 07753-4859
Site 0146
Not yet recruiting
Local Institution - 0154
New Haven, Connecticut, 06520
Site 0154
Not yet recruiting
Local Institution - 0158
Orange, California, 92868
Site 0158
Not yet recruiting
Local Institution - 0171
Orangeburg, New York, 10962
Site 0171
Not yet recruiting
Local Institution - 0141
Orem, Utah, 84097
Site 0141
Not yet recruiting
Apg Research, Llc
Orlando, Florida, 32803
Morteza Nadjafi, Site 0032, 407-423-7149
Recruiting
Local Institution - 0163
Phoenix, Arizona, 85006
Site 0163
Not yet recruiting
Local Institution - 0150
Pittsburgh, Pennsylvania, 15213-3403
Site 0150
Not yet recruiting
Local Institution - 0165
Plano, Texas, 75093
Withdrawn
Local Institution - 0176
Plano, Texas, 75093
Site 0176
Not yet recruiting
Local Institution - 0050
Richmond, Virginia, 23284
Site 0050
Not yet recruiting
Local Institution - 0172
Saint Charles, Missouri, 63304
Site 0172
Not yet recruiting
Local Institution - 0181
San Antonio, Texas, 78249
Site 0181
Not yet recruiting
Local Institution - 0174
San Diego, California, 92102
Site 0174
Not yet recruiting
UCSF Neurosciences Clinical Research Unit (NCRU)
San Francisco, California, 94158
Danai Nyasha Chagwedera, Site 0089, 415-746-9047
Recruiting
Local Institution - 0157
San Rafael, California, 94903
Site 0157
Not yet recruiting
Local Institution - 0066
Spring, Texas, 77381
Site 0066
Not yet recruiting
Local Institution - 0156
Staten Island, New York, 10314
Site 0156
Not yet recruiting
Denali Health Atlanta, LLC
Stone Mountain, Georgia, 30083
Maria Johnson, Site 0039
Recruiting
Local Institution - 0151
The Bronx, New York, 10461
Site 0151
Not yet recruiting
Local Institution - 0139
West Chester, Ohio, 45069
Withdrawn
Local Institution - 0167
West Point, Utah, 84015
Site 0167
Not yet recruiting
Local Institution - 0059
Worcester, Massachusetts, 01608
Site 0059
Not yet recruiting

Other trials in United States

Poland10 sites, 6 recruiting

Local Institution - 0126
Gdansk, Pomeranian Voivodeship, 80-542
Site 0126
Not yet recruiting
Local Institution - 0121
Gdansk, 80-546
Site 0121
Not yet recruiting
Local Institution - 0124
Katowice, 40-146
Withdrawn
Local Institution - 0122
Lublin, 20-059
Withdrawn
Local Institution - 0177
Lublin, 20-701
Site 0177
Not yet recruiting
Local Institution - 0128
Poznan, Greater Poland Voivodeship, 60-744
Site 0128
Not yet recruiting
Local Institution - 0123
Szczecin, West Pomeranian Voivodeship, 70-419
Site 0123
Not yet recruiting
Local Institution - 0127
Warsaw, Masovian Voivodeship, 02-957
Withdrawn
Local Institution - 0125
Wroclaw, Lower Silesian Voivodeship, 54-234
Withdrawn
Local Institution - 0178
Zabrze, 41-807
Site 0178
Not yet recruiting

Other trials in Poland

Japan7 sites, 7 recruiting

Local Institution - 0086
Bunkyo-ku, Tokyo, 113-8431
Site 0086
Not yet recruiting
Local Institution - 0075
Chikugo, Fukuoka, 833-0041
Site 0075
Not yet recruiting
Local Institution - 0062
Miyakonojō, Miyazaki, 885-0093
Site 0062
Not yet recruiting
Local Institution - 0056
Ōta-ku, Tokyo, 143-8541
Site 0056
Not yet recruiting
Goryokai Medical Corporation - Goryokai Hospital
Sapporo, Hokkaido, 002-8029
Kimihiro Nakajima, Site 0073, +81-11-771-5660
Recruiting
Local Institution - 0063
Yokohama, Kanagawa, 213-8507
Site 0063
Not yet recruiting
Local Institution - 0025
Zentsujichó, Kagawa-ken, 765-8507
Site 0025
Not yet recruiting

Other trials in Japan

Romania6 sites, 6 recruiting

Local Institution - 0029
Bucharest, Bucharest, 041914
Site 0029
Not yet recruiting
Local Institution - 0040
Bucharest, 021056
Site 0040
Not yet recruiting
Cabinet Medical Individual Dr Gheorghita Karina Lidia
Bucharest, 031871
Karina Gheorghita, Site 0042
Recruiting
Cluj Napoca Emergency Hospital for Children, Department of Pediatric Psychiatry
Cluj-Napoca, 400370
Elena Predescu, Site 0031
Recruiting
Local Institution - 0008
Iași, 700282
Site 0008
Not yet recruiting
Emergency Clinical Hospital For Children Louis Turcanu Timis
Timișoara, 300329
Laura Nussbaum, Site 0038
Recruiting

Other trials in Romania

Canada5 sites, 5 recruiting

Local Institution - 0138
Calgary, Alberta, T2N 4Z6
Site 0138
Not yet recruiting
Local Institution - 0111
Edmonton, Alberta, T6G 1Z1
Site 0111
Not yet recruiting
Local Institution - 0110
Kingston, Ontario, K7L4X3
Site 0110
Not yet recruiting
Local Institution - 0112
Montreal, Quebec, H3T 1C5
Site 0112
Not yet recruiting
Local Institution - 0113
Toronto, Ontario, M4G 1R8
Site 0113
Not yet recruiting

Other trials in Canada

Australia4 sites, 4 recruiting

Local Institution - 0106
Brisbane, Queensland, 4101
Site 0106
Not yet recruiting
Local Institution - 0108
Melbourne, Victoria, 3052
Site 0108
Not yet recruiting
Local Institution - 0109
Melbourne, Victoria, 3168
Site 0109
Not yet recruiting
Local Institution - 0107
Westmead, New South Wales, 2145
Site 0107
Not yet recruiting

Other trials in Australia

India4 sites, 4 recruiting

Local Institution - 0183
Kanpur, Uttar Pradesh, 208002
Site 0183
Not yet recruiting
Local Institution - 0135
Kolkata, West Bengal, 700027
Site 0135
Not yet recruiting
Local Institution - 0134
Kozhikode, Kerala, 673009
Site 0134
Not yet recruiting
Local Institution - 0136
Nagpur, Maharashtra, 441108
Site 0136
Not yet recruiting

Other trials in India

Spain4 sites, 4 recruiting

Local Institution - 0101
Barcelona, 08036
Site 0101
Not yet recruiting
Local Institution - 0099
Barcelona, 8035
Site 0099
Not yet recruiting
Local Institution - 0098
Madrid, 28007
Site 0098
Not yet recruiting
Local Institution - 0100
Madrid, 28031
Site 0100
Not yet recruiting

Other trials in Spain

France3 sites, 3 recruiting

Local Institution - 0118
Bordeaux, 33076
Site 0118
Not yet recruiting
Local Institution - 0120
Bron, 69678
Site 0120
Not yet recruiting
Local Institution - 0119
Paris, 75019
Site 0119
Not yet recruiting

Other trials in France

Hungary3 sites, 3 recruiting

Local Institution - 0129
Budapest, 1143
Site 0129
Not yet recruiting
Local Institution - 0130
Gyula, 5700
Site 0130
Not yet recruiting
Local Institution - 0131
Szeged, 6720
Site 0131
Not yet recruiting

Other trials in Hungary

Puerto Rico2 sites, 2 recruiting

Local Institution - 0180
San Juan, 00927
Site 0180
Not yet recruiting
Local Institution - 0013
San Juan, 917
Site 0013
Not yet recruiting

Other trials in Puerto Rico

About this study

Official title: A Phase 3 Multicenter, Open-label Study to Assess the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride in Children and Adolescents With Psychiatric Disorders

The purpose of this study is to evaluate the long-term safety and tolerability of Xanomeline and Trospium Chloride for the treatment of psychiatric disorders in children and adolescents

Conditions: Schizophrenia, Autism-Related Irritability
Being tested: KarXT, KarX-EC
Keywords: KarXT, Adolescent schizophrenia, Autism, Children and adolescents, Irritability
Medical subject headings: Schizophrenia, Autistic Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

KarXTDrug
Also called BMS-986510, Xanomeline/Trospium chloride
Specified dose on specified days
KarX-ECDrug
Also called BMS-986519, Xanomeline Enteric-coated
Specified dose on specified days

Study groups in NCT07424404
Study group	Role	What they receive
Administration of KarXT for Schizophrenia	Experimental	Not described Receives: Drug: KarXT
Administration of KarXT + KarX-EC for Autism Spectrum Disorder	Experimental	Not described Receives: Drug: KarXT; Drug: KarX-EC

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of participants with treatment emergent adverse events (TEAEs)
Measured: Up to 56 weeks
Number of participants with adverse events of special interest (AESIs)
Measured: Up to 56 weeks
Number of participants with serious adverse events (SAEs)
Measured: Up to 56 weeks

Secondary outcomes (6)

Number or participants with cholinergic symptoms
Measured: Up to 56 weeks
Number of participants with anticholinergic symptoms
Measured: Up to 56 weeks
Number of participants with suicidal ideation and behavior assessed using the Columbia Suicide Severity Rating Scale (C-SSRS)
Measured: Up to 56 weeks
Change from baseline on the Simpson-Angus Scale (SAS)
Measured: Up to 52 weeks
Change from baseline on the Abnormal Involuntary Movement Scale (AIMS)
Measured: Up to 52 weeks
Change from baseline on the Barnes-Akathisia Rating Scale (BARS)
Measured: Up to 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Apr 20268 Mar 2030

First posted20 Feb 2026
Study start7 Apr 2026
Primary completion8 Mar 2030 (estimated)
Study completion8 Mar 2030 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for SchizophreniaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 400 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07424404
Sponsor's protocol ID: CN012-0021
Other IDs: 2025-524062-16-00, U1111-1325-9994, 2025
Status last verified: Oct 2026
First submitted: 13 Feb 2026
Last updated: 15 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

Interested in taking part?

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

855-907-3286

Clinical.Trials@bms.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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All Schizophrenia trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3 Multicenter, Open-label Study to Assess the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride in Children and Adolescents With Psychiatric Disorders
ClinicalTrials.gov ID: NCT07424404
Acronym / sponsor ID: CN012-0021
Conditions: Schizophrenia, Autism-Related Irritability
Keywords: KarXT, Adolescent schizophrenia, Autism, Children and adolescents, Irritability
Phase: Phase 3
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 400 participants (estimated)
Lead sponsor: Karuna Therapeutics, Inc., a Bristol Myers Squibb companyIndustry (pharma, biotech, devices)
Study start: 7 Apr 2026 (actual)
Primary completion: 8 Mar 2030 (estimated)
Study completion: 8 Mar 2030 (estimated)
First posted: 20 Feb 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to evaluate the long-term safety and tolerability of Xanomeline and Trospium Chloride for the treatment of psychiatric disorders in children and adolescents

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Administration of KarXT for Schizophrenia	Experimental	Drug: KarXT
Administration of KarXT + KarX-EC for Autism Spectrum Disorder	Experimental	Drug: KarXT, Drug: KarX-EC

Who may qualify

Ages: 5 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (2 listed)

Participants must have completed the double-blind treatment period (ie, Visit 8) of Study CN0120020 or the double-blind treatment period (ie, Week 8) of Study CN0120044 or CN0120045 without an adverse event (AE) that, in the opinion of the investigator, may indicate an unacceptable safety risk.
De-novo participants must have confirmed diagnosis of ASD with symptoms of irritability, as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria, confirmed by the Kiddie Schedule for Affective Disorders and Schizophrenia-Present and Lifetime version (K-SADS-PL).

Key exclusion criteria (4 listed)

Participants must not have a significant risk of committing violent acts, serious self-harm, or attempting suicide based on history or routine psychiatric status examination, or those who are homicidal or are considered to be a high risk to others, or who have an answer of "Yes" on Questions 4 or 5 on the suicidal ideation section of the "Since Last Visit" version of the C-SSRS at baseline (Visit 1). Nonsuicidal, self-injurious behavior is not exclusionary.
Participants must not have any clinically significant abnormality including any finding(s) from the physical examination, vital signs, or ECG at the end of treatment visit of Study CN0120020, CN0120044 or CN00120045 that the investigator, in consultation with the Sponsor Medical Monitor, would jeopardize the safety of the participant.
Participants must not have either a systolic blood pressure (sBP) or diastolic blood pressure (dBP) meeting criteria for stage 2 hypertension (HTN), regardless of the presence or absence of symptoms.
Other protocol-defined Inclusion/Exclusion criteria apply.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
KarXTAlso: BMS-986510, Xanomeline/Trospium chlorideSpecified dose on specified days	Drug	Administration of KarXT + KarX-EC for Autism Spectrum Disorder, Administration of KarXT for Schizophrenia
KarX-ECAlso: BMS-986519, Xanomeline Enteric-coatedSpecified dose on specified days	Drug	Administration of KarXT + KarX-EC for Autism Spectrum Disorder

Primary outcome

Number of participants with treatment emergent adverse events (TEAEs)
Time frame: Up to 56 weeks
Number of participants with adverse events of special interest (AESIs)
Time frame: Up to 56 weeks
Number of participants with serious adverse events (SAEs)
Time frame: Up to 56 weeks

6 secondary outcomes

Number or participants with cholinergic symptoms
Time frame: Up to 56 weeks
Number of participants with anticholinergic symptoms
Time frame: Up to 56 weeks
Number of participants with suicidal ideation and behavior assessed using the Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: Up to 56 weeks
Change from baseline on the Simpson-Angus Scale (SAS)
Time frame: Up to 52 weeks
Change from baseline on the Abnormal Involuntary Movement Scale (AIMS)
Time frame: Up to 52 weeks
Change from baseline on the Barnes-Akathisia Rating Scale (BARS)
Time frame: Up to 52 weeks

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
BMS Clinical Trial InformationLink provided by the sponsor.
BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
Individual participant dataSharing planned: Yes. BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

Related trials for Schizophrenia

Recruiting
Supporting Patients by Family Education in Psychotic Illness: A Prospective Cohort Study
Psychotic Disorders, Family Members
RecruitingObservational study
The ATP Project (Antipsychotic-TEP-Psychosis)
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RecruitingPhase 2
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact

855-907-3286

Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #. contact

Bristol-Myers Squibb study director

Bristol-Myers Squibb

104 sites in 11 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing KarXT and KarX-EC in people with Schizophrenia and Autism-Related Irritability, run by Karuna Therapeutics, Inc., a Bristol Myers Squibb company at 104 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 104 sites in United States, Poland, Japan, Romania, Canada and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact BMS Clinical Trials Contact Center www.BMSClinicalTrials.com (855-907-3286, Clinical.Trials@bms.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with treatment emergent adverse events (TEAEs) (time frame: Up to 56 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07424404.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.