A Study to Assess Efficacy and Safety of Adjunctive KarXT in Subjects With Inadequately Controlled Symptoms of Schizophrenia

PHASE3CompletedINTERVENTIONAL
Enrollment

396

Participants

Timeline

Start Date

November 12, 2021

Primary Completion Date

March 19, 2025

Study Completion Date

March 19, 2025

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

DRUG

Placebo

Placebo Capsules

Trial Locations (166)

1113

Medical Center 'Sv.Naum', Sofia

1202

MHC - Sofia, EOOD, Sofia

1282

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

1407

Local Institution - 320, Sofia

1408

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

1431

Medical Center Akademika EOOD, Sofia

1510

Medical Center Hera EOOD, Sofia

1680

Medical Center Intermedica, OOD, Sofia

2600

Medical Centre 'Asklepii', OOD, Dupnitsa

3000

Mental Health Center-Vratsa EOOD, Vratsa

4002

UMHAT Sv. Georgi, EAD, Plovdiv

4004

Local Institution - 321, Plovdiv

5800

Medical Center Medconsult Pleven OOD, Pleven

UMHAT 'Dr. Georgi Stranski', EAD, Pleven

5980

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

6100

MHAT Dr. Hristo Stambolski, EOOD, Kazanlak

6600

Medical Center Lifemed, Kardzhali

7200

Local Institution - 313, Razgrad

7700

Medical Center VAS OOD, Targovishte

8800

MHAT Dr Ivan Seliminski AD, Sliven

9020

DCC Mladost M - Varna, OOD, Varna

10017

Synexus Clinical Research US, Inc., New York

10027

Manhattan Psychiatric Center, New York

10036

Manhattan Behavioral Medicine, PLLC, New York

10314

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

10825

Local Institution - 804, Bucharest

11000

Clinical Center ' Dr Dragisa Misovic Dedinje', Belgrade

Institute of Mental Health, Belgrade

Local Institution - 413, Belgrade

Local Institution - 417, Belgrade

University Clinical Center of Serbia, Belgrade

14623

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

18000

University Clinical Center Nis, Niš

18202

Special Hospital for Psychiatric Diseases 'Gornja Toponica', Niš

20877

CenExel Center for Behavioral Health, Gaithersburg

23330

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

26220

"Special Hospital for Psychiatric Diseases Kovin", Kovin

Special Hospital for Psychiatric Diseases 'Kovin', Kovin

26300

Special Hospital for Psychiatric Disease 'Dr Slavoljub Bakalovic', Vršac

28601

Clinical Trials of America - Psychiatry, Hickory

30030

CenExel iResearch Atlanta, Decatur

30060

Psych Atlanta, P.C., Marietta

30303

Grady Memorial Hospital, Atlanta

30328

Synexus Clinical Research US, Inc., Atlanta

30331

Local Institution - 192, Atlanta

30912

Local Institution - 135, Augusta

31405

CenExel iResearch, LLC, Savannah

32763

Local Institution - 124, Orange City

33012

Reliable Clinical Research LLC, Hialeah

33014

San Marcus Research Clinic, Inc., Miami Lakes

33016

Behavioral Clinical Research , Inc, Miami

Assertive Research Center, Miami Lakes

33024

Pines Care Research Center, Inc., Pembroke Pines

33122

Premier Clinical Research Institute, Inc., Miami

33134

Local Institution - 186, Coral Gables

33166

Envision Trials LLC, Miami Springs

33629

Interventional Psychiatry of Tampa Bay, Tampa

34000

University Clinical Center Kragujevac, Kragujevac

40874

Local Institution - 810, Bucharest

41914

Local Institution - 802, Bucharest

44125

Local Institution - 168, Garfield Heights

44131

Insight Clinical Trials LLC, Independence

45219

University of Cincinnati Medical Center, Cincinnati

48105

Michigan Clinical Research Institute PC, Ann Arbor

49001

Western Michigan University Homer Stryker M.D. School of Medicine, Kalamazoo

60222

Local Institution - 807, Bucharest

60611

Northwestern University, Chicago

60640

Uptown Research Institute, LLC, Chicago

63128

Local Institution - 129, St Louis

63141

Arch Clinical Trials LLC, St Louis

66208

Phoenix Medical Research, Inc., Prairie Village

68144

Omaha Insomnia and Psychiatric Services LLC, Omaha

72204

Pillar Clinical Research, LLC, Little Rock

72211

Woodland International Research Group, LLC, Little Rock

73112

The Rivus Wellness & Research Institute, Oklahoma City

75062

University Hills Clinical Research - Irving, Irving

75080

Pillar Clinical Research, LLC, Richardson

75115

InSite Clinical Research; LLC, DeSoto

76104

JPS Health Network, Fort Worth

77030

Ben Taub Hospital, Houston

77074

Clinical Trial Network LLC, Houston

77407

At Health Texas, Richmond

Perceptive Pharma Research, Richmond

78754

Community Clinical Research, Inc., Austin

85012

IMA Clinical Research, Phoenix

Local Institution - 147, Phoenix

89102

Altea Research Institute, Las Vegas, Las Vegas

90230

Proscience Research Group, Culver City

90504

CenExel Collaborative Neuroscience Research, Torrance

90631

Omega Clinical Trials, La Habra

90660

CNRI - Los Angeles, LLC, Pico Rivera

90703

Synexus Clinical Research US, Inc., Cerritos

91403

Encino Hospital Medical Center, Los Angeles

91945

Synergy Clinical Research of Escondido, Lemon Grove

92056

Excell Research, Inc., Oceanside

92123

Cnri-San Diego, San Diego

92626

Clinical Innovations Inc., Costa Mesa

92805

Advanced Research Center, Inc., Anaheim

92845

CenExel Collaborative Neuroscience Research, Garden Grove

92868

Neuropsychiatric Research Center of Orange County, Orange

94305

Stanford University School of Medicine, Stanford

94549

Sunwise Clinical Research, LLC., Lafayette

97403

Prevention Science Institute, Eugene

98007

Northwest Clinical Research Center, Bellevue

200157

Local Institution - 808, Craiova

226003

Local Institution - 612, Lucknow

305001

Local Institution - 615, Ajmer

334003

Local Institution - 618, Bikaner

360001

Local Institution - 606, Rajkot

380008

Local Institution - 607, Ahmedabad

380013

Local Institution - 604, Ahmedabad

390021

Local Institution - 613, Vadodara

395001

Local Institution - 609, Surat

400008

Local Institution - 619, Mumbai

422001

Local Institution - 608, Nashik

422005

Local Institution - 605, Nashik

431005

Local Institution - 610, Aurangabad

440010

Local Institution - 603, Nagpur

500123

Local Institution - 803, Brasov

550281

Local Institution - 805, Sibiu

570001

Local Institution - 601, Mysore

575003

Local Institution - 614, Mangalore

575018

Local Institution - 602, Mangalore

590001

Local Institution - 617, Belgavi

673009

Local Institution - 611, Kozhikode

700282

Local Institution - 806, Iași

781032

Local Institution - 616, Guwahati

800179

Local Institution - 801, Galati

90706-7079

CITrials - Bellflower, Bellflower

92506-3237

CenExel Clinical Innovations, Inc., Riverside

33016-1814

Galiz Research, LLC, Hialeah

33319-4985

Adaptive Clinical Research, Inc, Lauderhill

60612-2307

American Medical Research, Inc., Chicago

71201-2986

IMA Clinical Research, Monroe

02114

Local Institution - 158, Boston

02118

Local Institution - 187, Boston

01655

Local Institution - 185, Worcester

49548-6927

Cherry Health, Grand Rapids

08009

CenExel Hassman Research Institute, Berlin

05701

Green Mountain Research Institute, Rutland

483-8248

Local Institution - 258, Kōnan

470-1168

Local Institution - 250, Toyoake-shi

961-0021

Local Institution - 257, Shirakawa

847-0031

Local Institution - 254, Karatsu-shi

819-0037

Local Institution - 255, Fukuoka

162-0843

Local Institution - 256, Tokyo

15-404

Local Institution - 506, Bialystok

80-546

Local Institution - 507, Gdansk

86-300

Local Institution - 509, Grudziądz

25-411

Local Institution - 501, Kielce

90-227

Local Institution - 503, Lodz

20-109

Local Institution - 505, Lublin

41-100

Local Institution - 502, Siemianowice Śląskie

62-002

Local Institution - 508, Suchy Las

95-080

Local Institution - 504, Tuszyn

041914

Local Institution - 809, Bucharest

TR15 3QE

Local Institution - 707, Pool, Reruth

BN1 9RY

Local Institution - 705, Brighton

SE5 8AF

Local Institution - 701, London

OL6 7SR

Local Institution - 706, Ashton-under-Lyne

M8 5RB

Local Institution - 710, Manchester

ME16 9PH

Local Institution - 709, Maidstone

OX3 7JX

Local Institution - 708, Oxford

G51 4TF

Local Institution - 704, Glasgow

KT16 9AU

Local Institution - 702, Chertsey

B4 6NH

Local Institution - 703, Birmingham

Sponsors
All Listed Sponsors
lead

Karuna Therapeutics

INDUSTRY

NCT05145413 - A Study to Assess Efficacy and Safety of Adjunctive KarXT in Subjects With Inadequately Controlled Symptoms of Schizophrenia | Biotech Hunter | Biotech Hunter