A Study to Evaluate the Long-term Safety and Tolerability of KarXT and KarX-EC for the Treatment of Schizophrenia and Autism-Related Irritability in Adolescents, Respectively

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified June 2026 by Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Sponsor
Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Information Provided by (Responsible Party)
Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Clinicaltrials.gov Identifier
NCT07424404
Other Study ID Numbers:
CN012-0021
First Submitted
February 12, 2026
First Posted
February 19, 2026
Last Update Posted
July 19, 2026
Last Verified
June 2026

ClinicalTrials.gov processed this data on July 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
SchizophreniaAutism-Related Irritability
Drug: KarXTDrug: KarXT

Study Design

Study TypeInterventional
Actual Enrollment400 participants
Design AllocationNon-Randomized
Interventional ModelSingle Group Assignment
MaskingNone (Open Label)
Primary PurposeTreatment
Official TitleA Phase 3 Multicenter, Open-label Study to Assess the Long-term Safety and Tolerability of KarXT in Adolescents (13 to 17 Years of Age) With Schizophrenia and KarXT+KarX-EC in Children and Adolescents (5 to 17 Years of Age) With Irritability Associated With Autism Spectrum Disorder
Study Start DateApril 6, 2026
Actual Primary Completion Date3yrs 7mos from now
Actual Study Completion Date3yrs 7mos from now

Groups and Cohorts

Group/CohortIntervention/Treatment
Administration of KarXT for Schizophrenia
Drug: KarXT
Specified dose on specified days
Administration of KarXT for Autism-related Irritability
Drug: KarXT
Specified dose on specified days

Outcome Measures

Primary Outcome Measures
  1. Number of participants with treatment emergent adverse events (TEAEs)
  2. Number of participants with adverse events of special interest (AESIs)
  3. Number of participants with serious adverse events (SAEs)
Secondary Outcome Measures
  1. Number or participants with procholinergic symptoms
  2. Number of participants with anticholinergic symptoms
  3. Number of participants with suicidal ideation and behavior assessed using the Columbia Suicide Severity Rating Scale (C-SSRS)
  4. Change from baseline on the Simpson-Angus Scale (SAS)
  5. Change from baseline on the Abnormal Involuntary Movement Scale (AIMS)
  6. Change from baseline on the Barnes-Akathisia Rating Scale (BARS)

Eligibility Criteria

Ages Eligible for Study(Child)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
Inclusion Criteria
Inclusion Criteria \- 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 investigator's opinion, may indicate an unacceptable safety risk.
Exclusion Criteria
Inclusion Criteria \- 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 investigator's opinion, may indicate an unacceptable safety risk. Exclusion Criteria
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, ECG at the end of treatment visit of Study CN0120020, CN0120044, or CN0120045 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.

Contacts and Locations

Sponsors and CollaboratorsKaruna Therapeutics, Inc., a Bristol Myers Squibb company
Locations
Local Institution - 0054 | Dothan Alabama, United States, 36303Local Institution - 0163 | Phoenix Arizona, United States, 85006Advanced Research Center Inc. | Anaheim California, United States, 92805Local Institution - 0159 | Anaheim California, United States, 92805Inland Psychiatric Medical Group. | Chino California, United States, 91710Local Institution - 0024 | Culver City California, United States, 90230Local Institution - 0162 | Glendale California, United States, 91203Local Institution - 0153 | Los Angeles California, United States, 90095Local Institution - 0158 | Orange California, United States, 92868Local Institution - 0083 | Redlands California, United States, 92373Local Institution - 0089 | San Francisco California, United States, 94158Local Institution - 0157 | San Rafael California, United States, 94903Local Institution - 0161 | Colorado Springs Colorado, United States, 80910Local Institution - 0154 | New Haven Connecticut, United States, 06520Local Institution - 0145 | Boca Raton Florida, United States, 33428Local Institution - 0160 | Gainesville Florida, United States, 32607Local Institution - 0164 | Gainesville Florida, United States, 32607Local Institution - 0168 | Hollywood Florida, United States, 33024Local Institution - 0166 | Orange City Florida, United States, 32763Apg Research, Llc | Orlando Florida, United States, 32803Atlanta Center for Medical Research | Atlanta Georgia, United States, 30331Salveo Integrative Health - Lawrenceville | Lawrenceville Georgia, United States, 30046Denali Health Atlanta, LLC | Stone Mountain Georgia, United States, 30083EmVenio Research Center - Prime Healthcare | Chicago Illinois, United States, 60622Local Institution - 0076 | Boston Massachusetts, United States, 02115Local Institution - 0132 | Lexington Massachusetts, United States, 02421Local Institution - 0059 | Worcester Massachusetts, United States, 01608Local Institution - 0152 | Bloomfield Hills Michigan, United States, 48302Local Institution - 0142 | Columbia Missouri, United States, 65201Local Institution - 0147 | Lincoln Nebraska, United States, 68526Local Institution - 0144 | Las Vegas Nevada, United States, 89128Local Institution - 0146 | Neptune City New Jersey, United States, 07753-4859Local Institution - 0061 | Great Neck New York, United States, 11021Local Institution - 0156 | Staten Island New York, United States, 10314Local Institution - 0151 | The Bronx New York, United States, 10461University of Cincinnati Cancer Institute | Cincinnati Ohio, United States, 45219Local Institution - 0148 | Cincinnati Ohio, United States, 45229Local Institution - 0139 | West Chester Ohio, United States, 45069Local Institution - 0143 | Danville Pennsylvania, United States, 17821Local Institution - 0150 | Pittsburgh Pennsylvania, United States, 15213-3403Local Institution - 0137 | Nashville Tennessee, United States, 37212Local Institution - 0149 | Dallas Texas, United States, 75243VAST Clinical Research | Garland Texas, United States, 75043Local Institution - 0169 | Houston Texas, United States, 77043Local Institution - 0165 | Plano Texas, United States, 75093Local Institution - 0066 | Spring Texas, United States, 77381Local Institution - 0141 | Orem Utah, United States, 84097Local Institution - 0140 | Provo Utah, United States, 84604Local Institution - 0167 | West Point Utah, United States, 84015Local Institution - 0050 | Richmond Virginia, United States, 23284Local Institution - 0155 | Everett Washington, United States, 98201Local Institution - 0084 | Ciudad Autónoma de Buenos Aires Buenos Aires, Argentina, C1107Local Institution - 0085 | La Plata Buenos Aires, Argentina, 1900Local Institution - 0036 | Buenos Aires , Argentina, C1405BOALocal Institution - 0035 | Córdoba , Argentina, X5003DCELocal Institution - 0116 | Santiago del Estero , Argentina, G4200DNDLocal Institution - 0107 | Westmead New South Wales, Australia, 2145Local Institution - 0106 | Brisbane Queensland, Australia, 4101Local Institution - 0108 | Melbourne Victoria, Australia, 3052Local Institution - 0109 | Melbourne Victoria, Australia, 3168Local Institution - 0111 | Edmonton Alberta, Canada, T6G 1Z1Local Institution - 0110 | Kingston Ontario, Canada, K7L4X3Local Institution - 0113 | Toronto Ontario, Canada, M4G 1R8Local Institution - 0112 | Montreal Quebec, Canada, H3T 1C5Local Institution - 0118 | Bordeaux , France, 33076Local Institution - 0120 | Bron , France, 69678Local Institution - 0119 | Paris , France, 75019Local Institution - 0121 | Gdansk , Germany, 80-546Local Institution - 0129 | Budapest , Hungary, 1143Local Institution - 0130 | Gyula , Hungary, 5700Local Institution - 0131 | Szeged , Hungary, 6720Local Institution - 0075 | Chikugo Fukuoka, Japan, 833-0041Goryokai Medical Corporation - Goryokai Hospital | Sapporo Hokkaido, Japan, 002-8029Local Institution - 0025 | Zentsujichó Kagawa-ken, Japan, 765-8507Local Institution - 0062 | Miyakonojō Miyazaki, Japan, 885-0093Local Institution - 0086 | Bunkyo-ku Tokyo, Japan, 113-8431Local Institution - 0056 | Ōta-ku Tokyo, Japan, 143-8541Local Institution - 0063 | Yokohama, Kanagawa , Japan, 213-8507Local Institution - 0128 | Poznan Greater Poland Voivodeship, Poland, 60-744Local Institution - 0125 | Wroclaw Lower Silesian Voivodeship, Poland, 54-234Local Institution - 0122 | Kraśnik Lublin Voivodeship, Poland, 23-210Local Institution - 0127 | Warsaw Masovian Voivodeship, Poland, 02-957Local Institution - 0126 | Gdansk Pomeranian Voivodeship, Poland, 80-542Local Institution - 0123 | Szczecin West Pomeranian Voivodeship, Poland, 70-419Local Institution - 0124 | Katowice , Poland, 40-146Local Institution - 0029 | Bucharest Bucharest, Romania, 041914Local Institution - 0040 | Bucharest , Romania, 021056Local Institution - 0042 | Bucharest , Romania, 031871Cluj Napoca Emergency Hospital for Children, Department of Pediatric Psychiatry | Cluj-Napoca , Romania, 400370Local Institution - 0008 | Iași , Romania, 700282Emergency Clinical Hospital For Children Louis Turcanu Timis | Timișoara , Romania, 300329Local Institution - 0101 | Barcelona , Spain, 08036Local Institution - 0099 | Barcelona , Spain, 8035Local Institution - 0098 | Madrid , Spain, 28007Local Institution - 0100 | Madrid , Spain, 28031
Investigators
Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb