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

PHASE3RecruitingINTERVENTIONAL
Enrollment

280

Participants

Timeline

Start Date

March 7, 2022

Primary Completion Date

March 19, 2026

Study Completion Date

March 19, 2026

Conditions
Schizophrenia
Interventions
DRUG

Xanomeline and Trospium Chloride Capsules

KarXT 50 mg/20 mg BID KarXT 75mg/20 mg BID KarXT 100mg/20 mg BID KarXT 125mg/30 mg BID

Trial Locations (175)

1113

RECRUITING

Medical Center 'Sv.Naum', Sofia

1202

RECRUITING

Center for Mental Health Center - Sofia District EOOD, Sofia

1282

RECRUITING

State Psychiatric Hospital 'Sv. Ivan Rilski', Novi Iskar, Novi Iskar

1408

RECRUITING

DCC 'Sv. Vrach and Sv. Sv. Kuzma and Damyan', OOD, Sofia

NOT_YET_RECRUITING

Local Institution - 320, Sofia

1463

RECRUITING

Medical Center Akademika EOOD, Sofia

1510

RECRUITING

Medical Center Hera EOOD, Sofia

1680

RECRUITING

Medical Center Intermedica, OOD, Sofia

2600

RECRUITING

Medical Centre 'Asklepii', OOD, Dupnitsa

3000

RECRUITING

Mental Health Center-Vratsa EOOD, Vratsa

4002

RECRUITING

UMHAT Sv. Georgi, EAD, Plovdiv

4004

NOT_YET_RECRUITING

Local Institution - 321, Plovdiv

5800

RECRUITING

Medical Center Medconsult Pleven OOD, Pleven

RECRUITING

UMHAT 'Dr. Georgi Stranski', EAD, Pleven

5980

RECRUITING

Ambulatory for Individual Practice for Specialized Medical Care in Psychiatry - Dr Ivo Natsov, Cherven Bryag

6100

RECRUITING

MHAT Dr. Hristo Stambolski, EOOD, Kazanlak

6600

RECRUITING

Medical Center Lifemed, Kardzhali

7200

RECRUITING

MHAT Sveti Ivan Rilski - Razgrad AD, Razgrad

7700

RECRUITING

Medical Center VAS OOD, Targovishte

8800

RECRUITING

MHAT Dr Ivan Seliminski AD, Sliven

9020

RECRUITING

DCC Mladost M - Varna, OOD, Varna

10017

NOT_YET_RECRUITING

Local Institution - 104, New York

10035

RECRUITING

Manhattan Psychiatric Center, New York

10036

RECRUITING

Manhattan Behavioral Medicine, PLLC, New York

11000

WITHDRAWN

Local Institution - 901, Prague

RECRUITING

Clinical Center ' Dr Dragisa Misovic Dedinje', Belgrade

NOT_YET_RECRUITING

Local Institution - 413, Belgrade

NOT_YET_RECRUITING

Local Institution - 417, Belgrade

RECRUITING

University Clinical Center of Serbia, Belgrade

14623

RECRUITING

Psychiatry and Alzheimer's Care of Rochester. PLLC, Rochester

18000

NOT_YET_RECRUITING

Local Institution - 415, Niš

20877

RECRUITING

CenExel Center for Behavioral Health, Gaithersburg

23330

NOT_YET_RECRUITING

Local Institution - 416, Novi Kneževac

RECRUITING

Special Hospital for Psychiatric Diseases 'Sveti Vracevi', Novi Kneževac

25067

WITHDRAWN

Local Institution - 905, Klecany

26220

RECRUITING

Special Hospital for Psychiatric Diseases 'Kovin', Kovin

26300

NOT_YET_RECRUITING

Local Institution - 409, Vršac

28601

RECRUITING

IMA Clinical Research Hickory, Hickory

30030

RECRUITING

CenExel iResearch Atlanta, Decatur

30060

RECRUITING

Psych Atlanta, P.C., Marietta

30328

RECRUITING

Synexus Clinical Research US, Inc., Atlanta

30331

RECRUITING

CenExel Atlanta Center for Medical Research, Atlanta

31405

NOT_YET_RECRUITING

Local Institution - 191, Savannah

33012

RECRUITING

Reliable Clinical Research LLC, Hialeah

33014

RECRUITING

San Marcus Research Clinic, Inc., Miami Lakes

33016

RECRUITING

Assertive Research Center, Miami Lakes

33025

RECRUITING

Pines Care Research Center, Inc., Pembroke Pines

33134

RECRUITING

Prestige Clinical Research Center, Inc., Coral Gables

33166

RECRUITING

South Florida Research Phase I-IV, Inc., Miami Springs

33629

RECRUITING

Interventional Psychiatry of Tampa Bay, Tampa

44125

NOT_YET_RECRUITING

Local Institution - 168, Garfield Heights

44131

COMPLETED

Local Institution - 163, Independence

45219

NOT_YET_RECRUITING

Local Institution - 165, Cincinnati

48105

NOT_YET_RECRUITING

Local Institution - 184, Ann Arbor

49001

NOT_YET_RECRUITING

Local Institution - 162, Kalamazoo

49503

NOT_YET_RECRUITING

Local Institution - 149, Grand Rapids

60222

WITHDRAWN

Local Institution - 807, Bucharest

60611

NOT_YET_RECRUITING

Local Institution - 177, Chicago

60612

NOT_YET_RECRUITING

Local Institution - 142, Chicago

NOT_YET_RECRUITING

Local Institution - 143, Chicago

60640

RECRUITING

Uptown Research Institute, LLC, Chicago

63128

COMPLETED

Local Institution - 129, St Louis

63141

RECRUITING

Arch Clinical Trials LLC, St Louis

68144

RECRUITING

Omaha Insomnia and Psychiatric Services LLC, Omaha

70868

WITHDRAWN

Local Institution - 903, Ostrava - Poruba

71201

NOT_YET_RECRUITING

Local Institution - 154, Monroe

72204

RECRUITING

Pillar Clinical Research LLC, Little Rock

72211

RECRUITING

Woodland International Research Group, LLC, Little Rock

73112

NOT_YET_RECRUITING

Local Institution - 194, Oklahoma City

75080

RECRUITING

Pillar Clinical Research, LLC, Richardson

75115

NOT_YET_RECRUITING

Local Institution - 189, DeSoto

76104

RECRUITING

JPS Health Network, Fort Worth

77030

NOT_YET_RECRUITING

Local Institution - 183, Houston

77074

RECRUITING

Clinical Trial Network LLC, Houston

77407

RECRUITING

At Health Texas, Richmond

78754

RECRUITING

Community Clinical Research, Inc., Austin

85012

RECRUITING

Alea Research, Phoenix

89102

RECRUITING

Altea Research Institute, Las Vegas, Las Vegas

NOT_YET_RECRUITING

Local Institution - 147, Las Vegas

90230

RECRUITING

Proscience Research Group, Culver City

90504

RECRUITING

CenExel Collaborative Neuroscience Research, Torrance

90660

RECRUITING

CNRI - Los Angeles, LLC, Pico Rivera

90703

RECRUITING

Synexus Clinical Research US, Inc., Cerritos

90706

RECRUITING

CITrials - Bellflower, Bellflower

91403

NOT_YET_RECRUITING

Local Institution - 141, Los Angeles

92056

RECRUITING

Excell Research, Inc., Oceanside

92123

NOT_YET_RECRUITING

Local Institution - 193, San Diego

92506

RECRUITING

CITrials, Inc. - Riverside & San Bernardino County, Riverside

92805

RECRUITING

Advanced Research Center, Inc., Anaheim

92845

RECRUITING

CenExel Collaborative Neuroscience Research, Garden Grove

92868

RECRUITING

NRC Research Institute, Orange

94305

RECRUITING

Stanford University School of Medicine, Stanford

94549

COMPLETED

Local Institution - 126, Lafayette

97403

RECRUITING

Prevention Science Institute, Eugene

98007

RECRUITING

Northwest Clinical Research Center, Bellevue

101421

RECRUITING

Institute of Mental Health, Belgrade

200157

WITHDRAWN

Local Institution - 808, Craiova

226003

WITHDRAWN

Local Institution - 612, Lucknow

305001

WITHDRAWN

Local Institution - 615, Ajmer

306041

NOT_YET_RECRUITING

Local Institution - 404, Kovin

360001

WITHDRAWN

Local Institution - 606, Rajkot

380008

WITHDRAWN

Local Institution - 607, Ahmedabad

380013

WITHDRAWN

Local Institution - 604, Ahmedabad

390021

WITHDRAWN

Local Institution - 613, Vadodara

395001

WITHDRAWN

Local Institution - 609, Surat

422001

WITHDRAWN

Local Institution - 608, Nashik

422005

WITHDRAWN

Local Institution - 605, Nashik

431005

WITHDRAWN

Local Institution - 610, Aurangabad

440010

WITHDRAWN

Local Institution - 603, Nagpur

500123

WITHDRAWN

Local Institution - 803, Brasov

550281

WITHDRAWN

Local Institution - 805, Sibiu

570001

WITHDRAWN

Local Institution - 601, Mysore

575003

WITHDRAWN

Local Institution - 614, Mangalore

575018

WITHDRAWN

Local Institution - 602, Mangalore

590002

WITHDRAWN

Local Institution - 617, Belgavi

673009

WITHDRAWN

Local Institution - 611, Kozhikode

700282

WITHDRAWN

Local Institution - 806, Iași

705631

RECRUITING

Special Hospital for Psychiatric Diseases 'Gornja Toponica', Gornja Toponica

781032

WITHDRAWN

Local Institution - 616, Guwahati

800179

WITHDRAWN

Local Institution - 801, Galati

1510053

WITHDRAWN

Local Institution - 910, Shibuya-ku

1540004

RECRUITING

Sangenjaya Neurology- Psychosomatic Clinic, Setagaya-ku

1540012

NOT_YET_RECRUITING

Local Institution - 253, Meguro-ku

90631-3842

NOT_YET_RECRUITING

Local Institution - 152, La Habra

91945-2956

RECRUITING

Synergy Clinical Research of Escondido, Lemon Grove

33016-1814

RECRUITING

Galiz Research, LLC, Hialeah

33319-4985

NOT_YET_RECRUITING

Local Institution - 105, Lauderhill

33122-1335

RECRUITING

Premier Clinical Research Institute, Inc., Miami

33016-1553

NOT_YET_RECRUITING

Local Institution - 120, Miami Lakes

32763-8350

NOT_YET_RECRUITING

Local Institution - 124, Orange City

30303-3031

RECRUITING

Emory University, Atlanta

30912-2613

NOT_YET_RECRUITING

Local Institution - 135, Augusta

66210-2670

NOT_YET_RECRUITING

Local Institution - 139, Overland Park

02114

NOT_YET_RECRUITING

Local Institution - 158, Boston

02118

RECRUITING

Boston University - PARENT, Boston

NOT_YET_RECRUITING

Local Institution - 269, Boston

01655

NOT_YET_RECRUITING

Local Institution - 185, Worcester

08009

RECRUITING

CenExel HRI Marlton, Berlin

10314-1607

RECRUITING

Richmond Behavioral Associates ERG Clinical Research - New York PLLC, Staten Island

75062-2757

RECRUITING

University Hills Clinical Research - Irving, Irving

05701

RECRUITING

Green Mountain Research Institute, Rutland

301 00

WITHDRAWN

Local Institution - 904, Pilsen

100 00

WITHDRAWN

Local Institution - 906, Prague

186 00

WITHDRAWN

Local Institution - 902, Prague

483-8248

NOT_YET_RECRUITING

Local Institution - 258, Konan-shi

470-1168

ACTIVE_NOT_RECRUITING

Local Institution - 250, Toyoake-shi

819-0037

COMPLETED

Local Institution - 255, Fukuoka

961-0021

ACTIVE_NOT_RECRUITING

Local Institution - 257, Shirakawa-shi

847-0031

ACTIVE_NOT_RECRUITING

Local Institution - 254, Karatsu-shi

162-0843

ACTIVE_NOT_RECRUITING

Local Institution - 256, Shinjuku-ku

15-404

WITHDRAWN

Local Institution - 506, Bialystok

80-546

WITHDRAWN

Local Institution - 507, Gdansk

86-300

WITHDRAWN

Local Institution - 509, Grudziądz

40-146

WITHDRAWN

Local Institution - 502, Katowice

25-411

WITHDRAWN

Local Institution - 501, Kielce

93-118

WITHDRAWN

Local Institution - 503, Lodz

20-109

WITHDRAWN

Local Institution - 505, Lublin

62-002

WITHDRAWN

Local Institution - 508, Suchy Las

95-080

WITHDRAWN

Local Institution - 504, Tuszyn

010825

WITHDRAWN

Local Institution - 804, Bucharest

040874

WITHDRAWN

Local Institution - 810, Bucharest

041914

WITHDRAWN

Local Institution - 802, Bucharest

WITHDRAWN

Local Institution - 809, Bucharest

34 000

NOT_YET_RECRUITING

Local Institution - 408, Kragujevac

RECRUITING

University Clinical Center Kragujevac, Kragujevac

RECRUITING

University Clinical Center Kragujevac, Kragujevac

RECRUITING

University Clinical Center Kragujevac, Kragujevac

PL31 2QN

WITHDRAWN

Local Institution - 707, Bodmin

BN1 9RY

WITHDRAWN

Local Institution - 705, Brighton

SE5 8AF

WITHDRAWN

Local Institution - 701, London

OL6 7SR

WITHDRAWN

Local Institution - 706, Ashton-under-Lyne

OX3 7JX

WITHDRAWN

Local Institution - 708, Oxford

KT16 9AU

WITHDRAWN

Local Institution - 702, Chertsey

B4 6NH

WITHDRAWN

Local Institution - 703, Birmingham

G51 4TF

WITHDRAWN

Local Institution - 704, Glasgow

Sponsors
All Listed Sponsors
lead

Karuna Therapeutics

INDUSTRY

NCT05304767 - An Extension Study to Assess Long-Term Safety and Tolerability of Adjunctive KarXT in Subjects With Inadequately Controlled Symptoms of Schizophrenia | Biotech Hunter | Biotech Hunter