Actively Recruiting
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
Led by Karuna Therapeutics, Inc., a Bristol Myers Squibb company · Updated on 2026-05-11
400
Participants Needed
59
Research Sites
204 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is 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
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have completed the double-blind treatment period of Study CN0120020 or Studies CN0120044 or CN0120045 without an adverse event that could indicate an unacceptable safety risk according to the investigator.
You will not qualify if you...
- Participants with significant risk of violent acts, serious self-harm, or recent suicidal ideation based on history or psychiatric evaluation are excluded.
- Participants with homicidal behavior or considered high risk to others are excluded.
- Participants with any clinically significant abnormality in physical exam, vital signs, or ECG at the end of prior related studies that jeopardizes safety are excluded.
- Participants with systolic or diastolic blood pressure meeting stage 2 hypertension criteria are excluded.
- Other protocol-defined inclusion or exclusion criteria apply.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 59 locations
1
Local Institution - 0077
Anaheim, California, United States, 92805
Not Yet Recruiting
2
Local Institution - 0058
Chino, California, United States, 91710
Not Yet Recruiting
3
Local Institution - 0024
Culver City, California, United States, 90230
Not Yet Recruiting
4
Local Institution - 0083
Redlands, California, United States, 92373
Not Yet Recruiting
5
Local Institution - 0089
San Francisco, California, United States, 94158
Not Yet Recruiting
6
Apg Research, Llc
Orlando, Florida, United States, 32803
Actively Recruiting
7
Atlanta Center for Medical Research
Atlanta, Georgia, United States, 30331
Actively Recruiting
8
Salveo Integrative Health - Lawrenceville
Lawrenceville, Georgia, United States, 30046
Actively Recruiting
9
Local Institution - 0039
Stone Mountain, Georgia, United States, 30083
Not Yet Recruiting
10
EmVenio Research Center - Prime Healthcare
Chicago, Illinois, United States, 60622
Actively Recruiting
11
Local Institution - 0076
Boston, Massachusetts, United States, 02115
Not Yet Recruiting
12
Local Institution - 0059
Worcester, Massachusetts, United States, 01608
Not Yet Recruiting
13
Local Institution - 0061
Great Neck, New York, United States, 11021
Not Yet Recruiting
14
University of Cincinnati Cancer Institute
Cincinnati, Ohio, United States, 45219
Actively Recruiting
15
Local Institution - 0097
Philadelphia, Pennsylvania, United States, 19139
Not Yet Recruiting
16
Local Institution - 0137
Nashville, Tennessee, United States, 37212
Not Yet Recruiting
17
Local Institution - 0046
Garland, Texas, United States, 75043
Not Yet Recruiting
18
Local Institution - 0066
Spring, Texas, United States, 77381
Not Yet Recruiting
19
Local Institution - 0050
Richmond, Virginia, United States, 23284
Not Yet Recruiting
20
Local Institution - 0084
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1107
Not Yet Recruiting
21
Local Institution - 0085
La Plata, Buenos Aires, Argentina, 1900
Not Yet Recruiting
22
Local Institution - 0036
Buenos Aires, Argentina, C1405BOA
Not Yet Recruiting
23
Local Institution - 0035
Córdoba, Argentina, X5003DCE
Not Yet Recruiting
24
Local Institution - 0116
Santiago del Estero, Argentina, G4200DND
Not Yet Recruiting
25
Local Institution - 0111
Edmonton, Alberta, Canada, T6G 1Z1
Not Yet Recruiting
26
Local Institution - 0110
Kingston, Ontario, Canada, K7L4X3
Not Yet Recruiting
27
Local Institution - 0113
Toronto, Ontario, Canada, M4G 1R8
Not Yet Recruiting
28
Local Institution - 0112
Montreal, Quebec, Canada, H3T 1C5
Not Yet Recruiting
29
Local Institution - 0118
Bordeaux, France, 33076
Not Yet Recruiting
30
Local Institution - 0120
Bron, France, 69678
Not Yet Recruiting
31
Local Institution - 0119
Paris, France, 75019
Not Yet Recruiting
32
Local Institution - 0121
Gdansk, Germany, 80-546
Not Yet Recruiting
33
Local Institution - 0129
Budapest, Hungary, 1143
Not Yet Recruiting
34
Local Institution - 0130
Gyula, Hungary, 5700
Not Yet Recruiting
35
Local Institution - 0131
Szeged, Hungary, 6720
Not Yet Recruiting
36
Local Institution - 0075
Chikugo, Fukuoka, Japan, 833-0041
Not Yet Recruiting
37
Goryokai Medical Corporation - Goryokai Hospital
Sapporo, Hokkaido, Japan, 002-8029
Actively Recruiting
38
Local Institution - 0025
Zentsujichó, Kagawa-ken, Japan, 765-8507
Not Yet Recruiting
39
Local Institution - 0062
Miyakonojō, Miyazaki, Japan, 885-0093
Not Yet Recruiting
40
Local Institution - 0086
Bunkyo-ku, Tokyo, Japan, 113-8431
Not Yet Recruiting
41
Local Institution - 0056
Ōta-ku, Tokyo, Japan, 143-8541
Not Yet Recruiting
42
Local Institution - 0063
Yokohama, Kanagawa, Japan, 213-8507
Not Yet Recruiting
43
Local Institution - 0128
Poznan, Greater Poland Voivodeship, Poland, 60-744
Not Yet Recruiting
44
Local Institution - 0125
Wroclaw, Lower Silesian Voivodeship, Poland, 54-234
Not Yet Recruiting
45
Local Institution - 0122
Kraśnik, Lublin Voivodeship, Poland, 23-210
Not Yet Recruiting
46
Local Institution - 0127
Warsaw, Masovian Voivodeship, Poland, 02-957
Not Yet Recruiting
47
Local Institution - 0126
Gdansk, Pomeranian Voivodeship, Poland, 80-542
Not Yet Recruiting
48
Local Institution - 0123
Szczecin, West Pomeranian Voivodeship, Poland, 70-419
Not Yet Recruiting
49
Local Institution - 0124
Katowice, Poland, 40-146
Not Yet Recruiting
50
Local Institution - 0029
Bucharest, Bucharest, Romania, 041914
Not Yet Recruiting
51
Local Institution - 0031
Cluj-Napoca, Cluj, Romania, 400370
Not Yet Recruiting
52
Local Institution - 0040
Bucharest, Romania, 021056
Not Yet Recruiting
53
Local Institution - 0042
Bucharest, Romania, 031871
Not Yet Recruiting
54
Local Institution - 0008
Iași, Romania, 700282
Not Yet Recruiting
55
Local Institution - 0038
Timișoara, Romania, 300011
Not Yet Recruiting
56
Local Institution - 0101
Barcelona, Spain, 08036
Not Yet Recruiting
57
Local Institution - 0099
Barcelona, Spain, 8035
Not Yet Recruiting
58
Local Institution - 0098
Madrid, Spain, 28007
Not Yet Recruiting
59
Local Institution - 0100
Madrid, Spain, 28031
Not Yet Recruiting
Research Team
B
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACT
F
First line of the email MUST contain NCT # and Site #.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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