Phase 3: testing KarXT for Irritability Associated With Autism Spectrum Disorder
This study wants to assess KarXT + KarX-EC for the treatment of irritability associated with autism in children and adolescents.
Official registry: https://clinicaltrials.gov/study/NCT07285798 · Bristol-Myers Squibb · enrollment listed as 176
What this phase means
Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are KarXT, KarX-EC, or KarXT + KarX-EC Matching Placebo. The registry lists allocation as randomized. This study wants to assess KarXT + KarX-EC for the treatment of irritability associated with autism in children and adolescents.
They plan to enroll about 176 people at 67 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of KarXT + KarX-EC in Children and Adolescents (5 to 17 Years of Age) With Irritability Associated With Autism Spectrum Disorder
Interventions: KarXT, KarX-EC, KarXT + KarX-EC Matching Placebo
Primary outcome (registry wording): Change From Baseline in the Aberrant Behavior Checklist Irritability (ABC-I) Score at Week 8
Who it is for (from inclusion criteria)
- Ages 5 Years to 17 Years
- Participants must have a confirmed diagnosis of ASD, as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria, confirmed by the K-SADS-PL and must be experiencing symptoms of irritability
- Participants must have an ABC-I ≥18 (Irritability subscale of the ABC) and CGIS specific to irritability ≥4, at screening and baseline (Day 1)
Who the registry excludes
- Participants must not have a current primary DSM-5 diagnosis of bipolar disorder, including bipolar II disorder, schizophrenia, schizoaffective disorder, major depressive episode as determined by clinical instrument, or post-traumatic stress disorder (PTSD)
- Exception Include: Participants with comorbid ADHD, provided that attention deficit/hyperactivity disorder (ADHD) is not the primary disorder, the participant is adequately treated and based on the investigator judgment the disorder is clinically stable
- Participants must not have history/presence of clinically significant disease or disorder that would jeopardize participant safety or validity of study results
- Participants must not have a risk for suicidal behavior, and any clinically significant abnormal laboratory test
- Other protocol-defined Inclusion/
Public study contact (from the registry)
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
67 listed- Local Institution - 0062 — Phoenix, Arizona (not_yet_recruiting)
- Cortica - Glendale — Glendale, California (recruiting)
- Local Institution - 0117 — Los Angeles, California (not_yet_recruiting)
- Local Institution - 0126 — Orange, California (not_yet_recruiting)
- Local Institution - 0132 — San Diego, California (not_yet_recruiting)
- Local Institution - 0115 — San Juan Capistrano, California (not_yet_recruiting)
- Cortica - Marin — San Rafael, California (recruiting)
- Local Institution - 0130 — New Haven, Connecticut (not_yet_recruiting)
- Local Institution - 0048 — Gainesville, Florida (not_yet_recruiting)
- Local Institution - 0080 — Orlando, Florida (not_yet_recruiting)
- Local Institution - 0072 — Decatur, Georgia (not_yet_recruiting)
- EmVenio Research - Chicago — Chicago, Illinois (recruiting)
+ 42 sites outside the US on the same record
FAQ about this NCT record
Is NCT07285798 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07285798?
Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07285798?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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