An Open-label Extension Study to Assess the Long-term Safety and Tolerability of Adjunctive KarXT in Subjects With Inadequately Controlled Symptoms of Schizophrenia

Status: Recruiting
Location: See all (169) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

This is a Phase 3, multicenter, 52-week, outpatient, open-label extension (OLE) study to evaluate the long-term safety and tolerability of adjunctive KarXT in subjects with schizophrenia with an inadequate response to their current antipsychotic treatment who previously completed the treatment period (Visit 8/Day 42 ± 3) of ARISE Study (KAR-012). The primary objective of the study is to assess the long-term safety and tolerability of adjunctive KarXT (a fixed dose combination of xanomeline and trospium chloride twice daily \[BID\]) in subjects with schizophrenia.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• Subject is aged ≥18 to \<66 years at the time of randomization of Study KAR-012

• Subject has successfully completed the treatment period of Study KAR-012

• Subject has been compliant with the procedures in Study KAR-012 (in the Investigator's judgement)

• Subject has been compliant with their background antipsychotic drug in Study KAR-012 in the opinion of the Investigator and based on subject and informant reporting Note: Subjects are required to remain on the same appropriate approved APD as in Study KAR-012 and should stay on that same dose throughout the study.

• Subject is capable of providing signed Informed Consent Form before any study assessments will be performed

• Subject resides in a stable living situation, in the opinion of the Investigator

• Subject has identified a reliable informant/caregiver willing and able to assist with study activities as needed throughout the subject's participation in the study. The informant can complete the study visits assessments via phone (as per local regulations). In Bulgaria, the informant needs to be physically present at all study visits where the Investigator determines that his/her input would be beneficial.

• Women of childbearing potential (WOCP), or men whose sexual partners are WOCP, must be able and willing to use at least 1 highly effective method of contraception during the study and for at least 1 menstrual cycle (e.g., 30 days) after the last dose of study drug. Sperm donation is not allowed for 30 days after the final dose of the study drug. A female subject is considered to be a WOCP after menarche and until she is in a postmenopausal state for 12 months or otherwise permanently sterile (for which acceptable methods include hysterectomy, bilateral salpingectomy, or bilateral oophorectomy).

Locations
United States
Arkansas
Pillar Clinical Research LLC
RECRUITING
Little Rock
Woodland International Research Group, LLC
RECRUITING
Little Rock
Arizona
Alea Research
RECRUITING
Phoenix
California
Advanced Research Center, Inc.
RECRUITING
Anaheim
CITrials - Bellflower
RECRUITING
Bellflower
Local Institution - 110
COMPLETED
Cerritos
Local Institution - 167
ACTIVE_NOT_RECRUITING
Culver City
Local Institution - 127
ACTIVE_NOT_RECRUITING
Garden Grove
Local Institution - 152
NOT_YET_RECRUITING
La Habra
Local Institution - 126
COMPLETED
Lafayette
Synergy Clinical Research of Escondido
RECRUITING
Lemon Grove
Local Institution - 141
WITHDRAWN
Los Angeles
Excell Research, Inc.
RECRUITING
Oceanside
NRC Research Institute
RECRUITING
Orange
CNRI - Los Angeles, LLC
RECRUITING
Pico Rivera
CITrials, Inc. - Riverside & San Bernardino County
RECRUITING
Riverside
Local Institution - 193
WITHDRAWN
San Diego
Local Institution - 164
ACTIVE_NOT_RECRUITING
Stanford
Local Institution - 109
ACTIVE_NOT_RECRUITING
Torrance
Florida
Prestige Clinical Research Center, Inc.
RECRUITING
Coral Gables
Galiz Research, LLC
RECRUITING
Hialeah
Reliable Clinical Research LLC
RECRUITING
Hialeah
Local Institution - 105
TERMINATED
Lauderhill
Local Institution - 171
ACTIVE_NOT_RECRUITING
Miami
Premier Clinical Research Institute, Inc.
RECRUITING
Miami
Assertive Research Center
RECRUITING
Miami Lakes
Local Institution - 120
WITHDRAWN
Miami Lakes
Local Institution - 173
ACTIVE_NOT_RECRUITING
Miami Lakes
Local Institution - 124
WITHDRAWN
Orange City
Pines Care Research Center, Inc.
RECRUITING
Pembroke Pines
Interventional Psychiatry of Tampa Bay
RECRUITING
Tampa
Georgia
CenExel Atlanta Center for Medical Research
RECRUITING
Atlanta
Emory University
RECRUITING
Atlanta
Local Institution - 111
ACTIVE_NOT_RECRUITING
Atlanta
Local Institution - 135
WITHDRAWN
Augusta
CenExel iResearch Atlanta
RECRUITING
Decatur
Psych Atlanta, P.C.
RECRUITING
Marietta
Local Institution - 191
WITHDRAWN
Savannah
Illinois
Local Institution - 142
WITHDRAWN
Chicago
Local Institution - 143
WITHDRAWN
Chicago
Local Institution - 177
WITHDRAWN
Chicago
Uptown Research Institute, LLC
RECRUITING
Chicago
Kansas
Local Institution - 139
WITHDRAWN
Overland Park
Louisiana
Local Institution - 154
WITHDRAWN
Monroe
Massachusetts
Boston University - PARENT
RECRUITING
Boston
Local Institution - 158
WITHDRAWN
Boston
Local Institution - 269
WITHDRAWN
Boston
Local Institution - 185
WITHDRAWN
Worcester
Maryland
Local Institution - 166
ACTIVE_NOT_RECRUITING
Gaithersburg
Michigan
Local Institution - 184
WITHDRAWN
Ann Arbor
Local Institution - 149
WITHDRAWN
Grand Rapids
Local Institution - 162
WITHDRAWN
Kalamazoo
Missouri
Arch Clinical Trials LLC
RECRUITING
St Louis
Local Institution - 129
COMPLETED
St Louis
North Carolina
Local Institution - 176
ACTIVE_NOT_RECRUITING
Hickory
Nebraska
Omaha Insomnia and Psychiatric Services LLC
RECRUITING
Omaha
New Jersey
CenExel HRI Marlton
RECRUITING
Berlin
Nevada
Local Institution - 147
WITHDRAWN
Las Vegas
Local Institution - 148
COMPLETED
Las Vegas
New York
Local Institution - 104
TERMINATED
New York
Local Institution - 157
ACTIVE_NOT_RECRUITING
New York
Manhattan Psychiatric Center
RECRUITING
New York
Psychiatry and Alzheimer's Care of Rochester. PLLC
RECRUITING
Rochester
Richmond Behavioral Associates ERG Clinical Research - New York PLLC
RECRUITING
Staten Island
Ohio
Local Institution - 165
WITHDRAWN
Cincinnati
Local Institution - 168
WITHDRAWN
Garfield Heights
Local Institution - 163
COMPLETED
Independence
Oklahoma
Local Institution - 194
WITHDRAWN
Oklahoma City
Oregon
Prevention Science Institute
RECRUITING
Eugene
Texas
Community Clinical Research, Inc.
RECRUITING
Austin
Local Institution - 189
WITHDRAWN
Desoto
JPS Health Network
RECRUITING
Fort Worth
Clinical Trial Network LLC
RECRUITING
Houston
Local Institution - 183
WITHDRAWN
Houston
Local Institution - 103
COMPLETED
Irving
Pillar Clinical Research, LLC
RECRUITING
Richardson
Local Institution - 159
ACTIVE_NOT_RECRUITING
Richmond
Vermont
Green Mountain Research Institute
RECRUITING
Rutland
Washington
Northwest Clinical Research Center
RECRUITING
Bellevue
Other Locations
Bulgaria
Ambulatory for Individual Practice for Specialized Medical Care in Psychiatry - Dr Ivo Natsov
RECRUITING
Cherven Bryag
Local Institution - 311
ACTIVE_NOT_RECRUITING
Dupnitsa
Local Institution - 316
COMPLETED
Kardzhali
MHAT Dr. Hristo Stambolski, EOOD
RECRUITING
Kazanlak
State Psychiatric Hospital 'Sv. Ivan Rilski', Novi Iskar
RECRUITING
Novi Iskar
Medical Center Medconsult Pleven OOD
RECRUITING
Pleven
UMHAT 'Dr. Georgi Stranski', EAD
RECRUITING
Pleven
Local Institution - 321
NOT_YET_RECRUITING
Plovdiv
UMHAT Sv. Georgi, EAD
RECRUITING
Plovdiv
Local Institution - 313
ACTIVE_NOT_RECRUITING
Razgrad
MHAT Dr Ivan Seliminski AD
RECRUITING
Sliven
Center for Mental Health Center - Sofia District EOOD
RECRUITING
Sofia
DCC 'Sv. Vrach and Sv. Sv. Kuzma and Damyan', OOD
RECRUITING
Sofia
Local Institution - 320
WITHDRAWN
Sofia
Medical Center 'Sv.Naum'
RECRUITING
Sofia
Medical Center Akademika EOOD
RECRUITING
Sofia
Medical Center Hera EOOD
RECRUITING
Sofia
Medical Center Intermedica, OOD
RECRUITING
Sofia
Medical Center VAS OOD
RECRUITING
Targovishte
DCC Mladost M - Varna, OOD
RECRUITING
Varna
Mental Health Center-Vratsa EOOD
RECRUITING
Vratsa
India
Local Institution - 604
WITHDRAWN
Ahmedabad
Local Institution - 607
WITHDRAWN
Ahmedabad
Local Institution - 615
WITHDRAWN
Ajmer
Local Institution - 610
WITHDRAWN
Aurangabad
Local Institution - 617
WITHDRAWN
Belgavi
Local Institution - 616
WITHDRAWN
Guwahati
Local Institution - 611
WITHDRAWN
Kozhikode
Local Institution - 612
WITHDRAWN
Lucknow
Local Institution - 602
WITHDRAWN
Mangalore
Local Institution - 614
WITHDRAWN
Mangalore
Local Institution - 601
WITHDRAWN
Mysore
Local Institution - 603
WITHDRAWN
Nagpur
Local Institution - 605
WITHDRAWN
Nashik
Local Institution - 608
WITHDRAWN
Nashik
Local Institution - 606
WITHDRAWN
Rajkot
Local Institution - 609
WITHDRAWN
Surat
Local Institution - 613
WITHDRAWN
Vadodara
Japan
Local Institution - 255
COMPLETED
Fukuoka
Local Institution - 254
ACTIVE_NOT_RECRUITING
Karatsu-shi
Local Institution - 258
WITHDRAWN
Konan-shi
Local Institution - 253
NOT_YET_RECRUITING
Meguro-ku
Sangenjaya Neurology- Psychosomatic Clinic
RECRUITING
Setagaya-ku
Local Institution - 910
WITHDRAWN
Shibuya-ku
Local Institution - 256
ACTIVE_NOT_RECRUITING
Shinjuku-ku
Local Institution - 257
ACTIVE_NOT_RECRUITING
Shirakawa-shi
Local Institution - 250
ACTIVE_NOT_RECRUITING
Toyoake-shi
Poland
Local Institution - 506
WITHDRAWN
Bialystok
Local Institution - 507
WITHDRAWN
Gdansk
Local Institution - 509
WITHDRAWN
Grudziądz
Local Institution - 502
WITHDRAWN
Katowice
Local Institution - 501
WITHDRAWN
Kielce
Local Institution - 503
WITHDRAWN
Lodz
Local Institution - 505
WITHDRAWN
Lublin
Local Institution - 508
WITHDRAWN
Suchy Las
Local Institution - 504
WITHDRAWN
Tuszyn
Romania
Local Institution - 803
WITHDRAWN
Brasov
Local Institution - 802
WITHDRAWN
Bucharest
Local Institution - 804
WITHDRAWN
Bucharest
Local Institution - 807
WITHDRAWN
Bucharest
Local Institution - 809
WITHDRAWN
Bucharest
Local Institution - 810
WITHDRAWN
Bucharest
Local Institution - 808
WITHDRAWN
Craiova
Local Institution - 801
WITHDRAWN
Galati
Local Institution - 806
WITHDRAWN
Iași
Local Institution - 805
WITHDRAWN
Sibiu
Serbia
Clinical Center ' Dr Dragisa Misovic Dedinje'
RECRUITING
Belgrade
Local Institution - 403
ACTIVE_NOT_RECRUITING
Belgrade
Local Institution - 413
WITHDRAWN
Belgrade
Local Institution - 417
WITHDRAWN
Belgrade
University Clinical Center of Serbia
RECRUITING
Belgrade
Local Institution - 411
ACTIVE_NOT_RECRUITING
Gornja Toponica
Local Institution - 404
NOT_YET_RECRUITING
Kovin
Special Hospital for Psychiatric Diseases 'Kovin'
RECRUITING
Kovin
Local Institution - 406
ACTIVE_NOT_RECRUITING
Kragujevac
Local Institution - 408
NOT_YET_RECRUITING
Kragujevac
University Clinical Center Kragujevac
RECRUITING
Kragujevac
University Clinical Center Kragujevac
RECRUITING
Kragujevac
Local Institution - 415
WITHDRAWN
Niš
Local Institution - 416
WITHDRAWN
Novi Kneževac
Special Hospital for Psychiatric Diseases 'Sveti Vracevi'
RECRUITING
Novi Kneževac
Local Institution - 409
WITHDRAWN
Vršac
United Kingdom
Local Institution - 706
WITHDRAWN
Ashton-under-lyne
Local Institution - 703
WITHDRAWN
Birmingham
Local Institution - 707
WITHDRAWN
Bodmin
Local Institution - 705
WITHDRAWN
Brighton
Local Institution - 702
WITHDRAWN
Chertsey
Local Institution - 704
WITHDRAWN
Glasgow
Local Institution - 701
WITHDRAWN
London
Local Institution - 708
WITHDRAWN
Oxford
Contact Information
Primary
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Clinical.Trials@bms.com
855-907-3286
Backup
First line of the email MUST contain the NCT# and Site #.
Time Frame
Start Date: 2022-03-07
Estimated Completion Date: 2026-03-19
Participants
Target number of participants: 280
Treatments
Experimental: Drug: KarXT
Related Therapeutic Areas
Sponsors
Leads: Karuna Therapeutics

This content was sourced from clinicaltrials.gov

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