What this study is
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
What's being tested
- KarXT
Intervention · DRUG
- KarX-EC
Intervention · DRUG
Both interventions
Specified dose on specified days
Study details
- 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
- Sponsor
- Karuna Therapeutics, Inc., a Bristol Myers Squibb company
- Conditions
- Schizophrenia · Autism-Related Irritability
- Enrolling
- 400 people
- Starts
- 2026-04-07
- Est. completion
- 2030-03-08
- Design
- Open-label, non-randomized, single group, Phase 3
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 5 Years – 17 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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).
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (105)
97 openContact for 76 of 97 open sites
- Site 0054 · Contact
Local Institution - 0054
Dothan, Alabama, United States
Not yet recruitingLocal Institution - 0163
Phoenix, Arizona, United States
Not yet recruitingAdvanced Research Center Inc.
Anaheim, California, United States
- Steven Macina, Site 0077 · Contact714-999-6688
RecruitingLocal Institution - 0159
Anaheim, California, United States
Not yet recruitingInland Psychiatric Medical Group.
Chino, California, United States
- Nandita Puchakayala, Site 0058 · Contact909-488-9116
RecruitingProscience Research Group
Culver City, California, United States
- Marina Bussel, Site 0024 · Contact424-227-8127
RecruitingLocal Institution - 0162
Glendale, California, United States
Not yet recruitingLocal Institution - 0153
Los Angeles, California, United States
Not yet recruitingLocal Institution - 0158
Orange, California, United States
Not yet recruitingLocal Institution - 0174
San Diego, California, United States
Not yet recruitingUCSF Neurosciences Clinical Research Unit (NCRU)
San Francisco, California, United States
- Danai Nyasha Chagwedera, Site 0089 · Contact415-746-9047
RecruitingLocal Institution - 0157
San Rafael, California, United States
Not yet recruitingLocal Institution - 0154
New Haven, Connecticut, United States
Not yet recruitingLocal Institution - 0145
Boca Raton, Florida, United States
Not yet recruitingLocal Institution - 0160
Gainesville, Florida, United States
Not yet recruitingLocal Institution - 0164
Gainesville, Florida, United States
Not yet recruitingResearch Centers of America - Hollywood - CenExel - PPDS
Hollywood, Florida, United States
- Edwin Gomez, Site 0168 · Contact954-604-3900
Recruiting- Recruiting
Local Institution - 0182
Virginia Gardens, Florida, United States
Not yet recruitingAtlanta Center for Medical Research
Atlanta, Georgia, United States
- Elyssa Barron, Site 0057 · Contact404-881-5800
RecruitingLocal Institution - 0173
Decatur, Georgia, United States
Not yet recruitingSalveo Integrative Health - Lawrenceville
Lawrenceville, Georgia, United States
- Shahzad Hashmi, Site 0103 · Contact
RecruitingDenali Health Atlanta, LLC
Stone Mountain, Georgia, United States
- Maria Johnson, Site 0039 · Contact
RecruitingEmVenio Research Center - Prime Healthcare
Chicago, Illinois, United States
- Mitchell Glaser, Site 0044 · Contact773-620-2995
RecruitingLocal Institution - 0170
Louisville, Kentucky, United States
Not yet recruitingBoston Children's Hospital
Boston, Massachusetts, United States
- Joseph Gonzalez-Heydrich, Site 0076 · Contact
RecruitingLocal Institution - 0132
Lexington, Massachusetts, United States
Not yet recruitingLocal Institution - 0059
Worcester, Massachusetts, United States
Not yet recruitingLocal Institution - 0152
Bloomfield Hills, Michigan, United States
Not yet recruitingLocal Institution - 0142
Columbia, Missouri, United States
Not yet recruitingLocal Institution - 0172
Saint Charles, Missouri, United States
Not yet recruitingLocal Institution - 0147
Lincoln, Nebraska, United States
Not yet recruitingLocal Institution - 0144
Las Vegas, Nevada, United States
Not yet recruitingLocal Institution - 0146
Neptune City, New Jersey, United States
Not yet recruitingLocal Institution - 0061
Great Neck, New York, United States
Not yet recruitingLocal Institution - 0171
Orangeburg, New York, United States
Not yet recruitingLocal Institution - 0156
Staten Island, New York, United States
Not yet recruitingLocal Institution - 0151
The Bronx, New York, United States
Not yet recruitingUniversity of Cincinnati Cancer Institute
Cincinnati, Ohio, United States
- Melissa DelBello, Site 0051 · Contact
RecruitingLocal Institution - 0148
Cincinnati, Ohio, United States
Not yet recruitingLocal Institution - 0143
Danville, Pennsylvania, United States
Not yet recruitingLocal Institution - 0150
Pittsburgh, Pennsylvania, United States
Not yet recruitingLocal Institution - 0137
Nashville, Tennessee, United States
Not yet recruitingLocal Institution - 0149
Dallas, Texas, United States
Not yet recruitingVAST Clinical Research
Garland, Texas, United States
- Asikaiwe Chima, Site 0046 · Contact
RecruitingEvolution Research Group
Houston, Texas, United States
- Carlin Barnes, Site 0169 · Contact
RecruitingLocal Institution - 0047
Houston, Texas, United States
Not yet recruitingLocal Institution - 0176
Plano, Texas, United States
Not yet recruitingLocal Institution - 0181
San Antonio, Texas, United States
Not yet recruitingLocal Institution - 0066
Spring, Texas, United States
Not yet recruitingLocal Institution - 0141
Orem, Utah, United States
Not yet recruitingLocal Institution - 0167
West Point, Utah, United States
Not yet recruitingLocal Institution - 0050
Richmond, Virginia, United States
Not yet recruitingLocal Institution - 0155
Everett, Washington, United States
Not yet recruitingLocal Institution - 0175
Chicago, Illinois, United States
WithdrawnLocal Institution - 0190
Neptune City, New Jersey, United States
WithdrawnLocal Institution - 0139
West Chester, Ohio, United States
WithdrawnLocal Institution - 0165
Plano, Texas, United States
Withdrawn
47 sites outside the US
Local Institution - 0107
Westmead, New South Wales, Australia
Not yet recruitingLocal Institution - 0106
Brisbane, Queensland, Australia
Not yet recruitingLocal Institution - 0108
Melbourne, Victoria, Australia
Not yet recruitingLocal Institution - 0109
Melbourne, Victoria, Australia
Not yet recruitingLocal Institution - 0138
Calgary, Alberta, Canada
Not yet recruitingLocal Institution - 0111
Edmonton, Alberta, Canada
Not yet recruitingLocal Institution - 0110
Kingston, Ontario, Canada
Not yet recruitingLocal Institution - 0113
Toronto, Ontario, Canada
Not yet recruitingLocal Institution - 0112
Montreal, Quebec, Canada
Not yet recruitingLocal Institution - 0118
Bordeaux, France
Not yet recruitingLocal Institution - 0120
Bron, France
Not yet recruitingLocal Institution - 0119
Paris, France
Not yet recruitingLocal Institution - 0129
Budapest, Hungary
Not yet recruitingLocal Institution - 0130
Gyula, Hungary
Not yet recruitingLocal Institution - 0131
Szeged, Hungary
Not yet recruitingLocal Institution - 0134
Kozhikode, Kerala, India
Not yet recruitingLocal Institution - 0136
Nagpur, Maharashtra, India
Not yet recruitingLocal Institution - 0183
Kanpur, Uttar Pradesh, India
Not yet recruitingLocal Institution - 0075
Chikugo, Fukuoka, Japan
Not yet recruitingGoryokai Medical Corporation - Goryokai Hospital
Sapporo, Hokkaido, Japan
- Kimihiro Nakajima, Site 0073 · Contact+81-11-771-5660
RecruitingNational Hospital Organization Shikoku Medical Center for Children and Adults
Zentsujichó, Kagawa-ken, Japan
- Yoshihiro Nakadoi, Site 0025 · Contact0877-62-1000
RecruitingLocal Institution - 0062
Miyakonojō, Miyazaki, Japan
Not yet recruiting- Recruiting
Toho University Omori Medical Center
Ōta-ku, Tokyo, Japan
- Takahiro Nemoto, Site 0056 · Contact03-3762-4151
RecruitingLocal Institution - 0063
Yokohama, Kanagawa, Japan
Not yet recruitingLocal Institution - 0128
Poznan, Greater Poland Voivodeship, Poland
Not yet recruitingLocal Institution - 0126
Gdansk, Pomeranian Voivodeship, Poland
Not yet recruitingLocal Institution - 0123
Szczecin, West Pomeranian Voivodeship, Poland
Not yet recruitingLocal Institution - 0121
Gdansk, Poland
Not yet recruitingLocal Institution - 0177
Lublin, Poland
Not yet recruitingLocal Institution - 0178
Zabrze, Poland
Not yet recruitingLocal Institution - 0180
San Juan, Puerto Rico
Not yet recruitingLocal Institution - 0013
San Juan, Puerto Rico
Not yet recruitingLocal Institution - 0029
Bucharest, Bucharest, Romania
Not yet recruitingLocal Institution - 0040
Bucharest, Romania
Not yet recruitingCabinet Medical Individual Dr Gheorghita Karina Lidia
Bucharest, Romania
- Karina Gheorghita, Site 0042 · Contact
RecruitingCluj Napoca Emergency Hospital for Children, Department of Pediatric Psychiatry
Cluj-Napoca, Romania
- Elena Predescu, Site 0031 · Contact
RecruitingLocal Institution - 0008
Iași, Romania
Not yet recruitingEmergency Clinical Hospital For Children Louis Turcanu Timis
Timișoara, Romania
- Laura Nussbaum, Site 0038 · Contact
RecruitingLocal Institution - 0101
Barcelona, Spain
Not yet recruitingLocal Institution - 0099
Barcelona, Spain
Not yet recruitingLocal Institution - 0098
Madrid, Spain
Not yet recruitingLocal Institution - 0100
Madrid, Spain
Not yet recruitingLocal Institution - 0125
Wroclaw, Lower Silesian Voivodeship, Poland
WithdrawnLocal Institution - 0127
Warsaw, Masovian Voivodeship, Poland
WithdrawnLocal Institution - 0124
Katowice, Poland
WithdrawnLocal Institution - 0122
Lublin, Poland
Withdrawn
Study team
Sponsor
Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Study ID CN012-0021
Study director
Bristol-Myers Squibb
Bristol-Myers Squibb
CONTACT
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACT
First line of the email MUST contain NCT # and Site #.
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.