Schizophrenia study: KarXT
Official title A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Schizophrenia in Adolescents (EMERGENT TEEN)
ClinicalTrials.gov ID: NCT07288567
What this study is testing
What is KarXT?
KarXT is an investigational oral medication being studied for the treatment of schizophrenia in adolescents.
Also referred to as BMS-986510.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study will see if KarXT works and is safe for adolescents with schizophrenia.
- Who it's for
- Adolescents who have schizophrenia.
- What's involved
- Participants will receive the drug KarXT and attend scheduled visits and tests.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 13 to 17
You may be able to join if
- Diagnosis of schizophrenia as defined by the The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition,Text Revision (DSM-5-TR)...
- 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).
You likely can't join if
- 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...
- All grades of hepatic impairment (mild [Child-Pugh Class A], moderate [Child-Pugh Class B], and severe [Child-Pugh Class C]).
- 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...
- Other protocol-defined Inclusion/Exclusion criteria apply.
The study team makes the final eligibility decision.
Where it is enrolling
- Anaheim, California, United States
- Chino, California, United States
- Culver City, California, United States
- San Francisco, California, United States
- Hollywood, Florida, United States
- Orlando, Florida, United States
- Atlanta, Georgia, United States
- Lawrenceville, Georgia, United States
- Stone Mountain, Georgia, United States
- Chicago, Illinois, United States
- Boston, Massachusetts, United States
- Cincinnati, Ohio, United States
- Garland, Texas, United States
- Houston, Texas, United States
- Sapporo, Hokkaido, Japan
- Zentsujichó, Kagawa-ken, Japan
- Bunkyo-ku, Tokyo, Japan
- Ōta-ku, Tokyo, Japan
- Bucharest, Romania
- Cluj-Napoca, Romania
+ 1 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 13 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Anaheim, California, United States; Chino, California, United States; Culver City, California, United States; San Francisco, California, United States; Hollywood, Florida, United States; Orlando, Florida, United States and 15 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.