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SchizophreniaPhase 3NCT07288567

A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Schizophrenia in Adolescents (EMERGENT TEEN)

A Phase 3 study testing KarXT in people with Schizophrenia, run by Bristol-Myers Squibb at 37 sites in 4 countries.

Recruiting

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

Sites and contacts
Official record

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Trial summary

The purpose of this study is to evaluate the efficacy and safety of KarXT for treatment of Schizophrenia in adolescents. Read more about this study

Who is it for?
Ages 13 to 17 years
Conditions the study is for
Schizophrenia
What is being tested?
KarXT
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
166 participants
Where
37 sitesin 4 countries
Study dates
29 Jan 2026to 18 Dec 2029
Phase
Phase 3

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 13 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Diagnosis of schizophrenia as defined by the 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) and experiencing symptoms of psychosis at screening (Visit 1).
  • PANSS total score of at least 70 at screening (Visit 1) and randomization (Visit 2).
  • Participant has a CGI-S score of ≥ 4 at screening (Visit 1) and randomization (Visit 2).

Who cannot join

  • Any primary DSM-5-TR disorder other than schizophrenia within 12 months before screening.
  • History or presence of clinically significant cardiovascular, pulmonary, hepatic impairment, renal, hematologic, GI, endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other condition that, in the opinion of the investigator, would jeopardize the safety of the participant or the validity of the study results.
  • All grades of hepatic impairment (mild [Child-Pugh Class A], moderate [Child-Pugh Class B], and severe [Child-Pugh Class C]). Participants with known intellectual disability defined as an IQ less than 70; or, either clinical evidence or known social or school history indicative of intellectual disability.
  • Any neurological disorder, except for Tourette's Syndrome.
  • Participants who have either a systolic blood pressure (sBP) or diastolic blood pressure (dBP) meeting criteria for stage 2 HTN, regardless of the presence or absence of symptoms.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Trial locations and contacts

37 sites in 4 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

37 sites in 4 countries

United States20 sites, 20 recruiting

  • Advanced Research Center Inc.

    Anaheim, California, 92805

    Steven Macina, Site 0077, 714-999-6688

    Recruiting

  • Atlanta Center for Medical Research

    Atlanta, Georgia, 30331

    Elyssa Barron, Site 0057, 404-881-5800

    Recruiting

  • Boston Children's Hospital

    Boston, Massachusetts, 02115

    Joseph Gonzalez-Heydrich, Site 0076

    Recruiting

  • Local Institution - 0122

    Chicago, Illinois, 60611

    Site 0122

    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 Dept of Psychiatry and Behavioral Neuroscience

    Cincinnati, Ohio, 45219

    Melissa DelBello, Site 0051

    Recruiting

  • Proscience Research Group

    Culver City, California, 90230

    Marina Bussel, Site 0024, 424-227-8127

    Recruiting

  • VAST Clinical Research

    Garland, Texas, 75043

    Asikaiwe Chima, Site 0046

    Recruiting

  • Local Institution - 0061

    Great Neck, New York, 11021

    Site 0061

    Not yet recruiting

  • Local Institution - 0119

    Hollywood, Florida, 33024

    Site 0119

    Not yet recruiting

  • Memorial Hermann

    Houston, Texas, 77043

    Carlin Barnes, Site 0120

    Recruiting

  • Salveo Integrative Health - Lawrenceville

    Lawrenceville, Georgia, 30046

    Shahzad Hashmi, Site 0106

    Recruiting

  • Local Institution - 0113

    Nashville, Tennessee, 37212

    Site 0113

    Not yet recruiting

  • Apg Research, Llc

    Orlando, Florida, 32803

    Morteza Nadjafi, Site 0032, 407-423-7149

    Recruiting

  • Local Institution - 0050

    Richmond, Virginia, 23220

    Site 0050

    Not yet recruiting

  • UCSF Neurosciences Clinical Research Unit (NCRU)

    San Francisco, California, 94158

    Danai Nyasha Chagwedera, Site 0089, 415-746-9047

    Recruiting

  • Local Institution - 0066

    Spring, Texas, 77381

    Site 0066

    Not yet recruiting

  • Denali Health Atlanta, LLC

    Stone Mountain, Georgia, 30083

    Maria Johnson, Site 0039

    Recruiting

  • Local Institution - 0059

    Worcester, Massachusetts, 01608

    Site 0059

    Not yet recruiting

Other trials in United States

Japan7 sites, 7 recruiting

  • Local Institution - 0086

    Bunkyo-ku, Tokyo, 113-8431

    Site 0086

    Not yet recruiting

  • Local Institution - 0075

    Chikugo-Shi, 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, 1438541

    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

Romania7 sites, 7 recruiting

  • Local Institution - 0029

    Bucharest, Bucharest, 041914

    Site 0029

    Not yet recruiting

  • Clinica Animedica Bucuresti

    Bucharest, 021056

    Monica Safer, Site 0040, 0722656378

    Recruiting

  • Cabinet Medical Individual Dr Gheorghita Karina Lidia

    Bucharest, 031871

    Karina Gheorghita, Site 0042, +40722171504

    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

  • Local Institution - 0030

    Sibiu, 550082

    Site 0030

    Not yet recruiting

  • Emergency Clinical Hospital For Children Louis Turcanu Timis

    Timișoara, 300329

    Laura Nussbaum, Site 0038

    Recruiting

Other trials in Romania

Colombia3 sites, 3 recruiting

  • Local Institution - 0001

    Barranquilla, 080020

    Site 0001

    Not yet recruiting

  • Local Institution - 0109

    Bello, Antioquia, 051053

    Site 0109

    Not yet recruiting

  • Local Institution - 0009

    Pereira, Risaralda Department, 660003

    Site 0009

    Not yet recruiting

Other trials in Colombia

About this study

Official title: A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Schizophrenia in Adolescents (13 to 17 Years of Age)

The purpose of this study is to evaluate the efficacy and safety of KarXT for treatment of Schizophrenia in adolescents.

Conditions
Schizophrenia
Being tested
KarXT, KarXT Matching Placebo
Medical subject headings
Schizophrenia

What participants receive

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

  • KarXTDrug

    Also called BMS-986510

    Specified dose on specified days

  • KarXT Matching PlaceboOther

    Specified dose on specified days

Study groups in NCT07288567
Study groupRoleWhat they receive
KarXTExperimentalNot described
Receives: Drug: KarXT
PlaceboPlacebo comparatorNot described
Receives: Other: KarXT Matching Placebo

What is being measured

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

  1. Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score

    Measured: Week 5

Secondary outcomes (7)

  1. Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score

    Measured: Week 5

  2. Change From Baseline in PANSS Positive Subscale Score

    Measured: Week 5

  3. Change From Baseline in PANSS Negative Subscale Score

    Measured: Week 5

  4. Change From Baseline in PANSS Marder Negative Factor Score

    Measured: Week 5

  5. Number of Participants With PANSS Response

    PANSS response will be determined by ≥ 30% reduction in PANSS total score.

    Measured: Week 5

  6. Change From Baseline in Clinical Global Impression - Improvement (CGI-I) Score

    Measured: Week 5

  7. Change From Baseline in Children's Global Assessment Scale (CGAS)) Score

    Measured: Week 5

Timeline

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

  1. First posted17 Dec 2025
  2. Study start29 Jan 2026
  3. Primary completion18 Dec 2029 (estimated)
  4. Study completion18 Dec 2029 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
166 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07288567
Sponsor's protocol ID
CN012-0020
Other IDs
2025-523711-11-00, U1111-1325-9936, 2025
Status last verified
Oct 2026
First submitted
16 Dec 2025
Last updated
6 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

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