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

ClinicalTrials.gov processed this data on June 18, 2024. Link to the current ClinicalTrials.gov record.

Recruitment Status

ENROLLING BY INVITATION (See Contacts and Locations)
Verified June 2024 by Karuna Therapeutics

Sponsor

Karuna Therapeutics

Information Provided by (Responsible Party)

Karuna Therapeutics

Clinicaltrials.gov Identifier

NCT05304767
Other Study ID Numbers: CN012-0009
First Submitted: March 21, 2022
First Posted: March 31, 2022
Last Update Posted: June 21, 2024
Last Verified: June 2024
History of Changes

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Study Description

Not Provided
Condition or Disease Intervention/Treatment
  • Schizophrenia
  • Drug: Xanomeline and Trospium Chloride Capsules

Study Design

Study TypeInterventional
Anticipated Enrollment280 participants
Design AllocationN/A
Interventional ModelSingle Group Assignment
MaskingNone (Open Label)
Primary PurposeTreatment
Official TitleAn Open-label Extension Study to Assess the Long-term Safety and Tolerability of Adjunctive KarXT in Subjects With Inadequately Controlled Symptoms of Schizophrenia
Study Start DateMarch 7, 2022
Anticipated Primary Completion DateFebruary 28, 2026
Anticipated Study Completion DateFebruary 28, 2026

Groups and Cohorts

Group/ CohortIntervention/ Treatment
  • Drug: KarXT
  • 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

Outcome Measures

Primary Outcome Measures

  1. Incidence of treatment-emergent adverse events (TEAEs) [From initial dose to safety follow-up visit (54 weeks) or early termination]

Secondary Outcome Measures

  1. Incidence of serious treatment-emergent adverse events (TEAEs) [From initial dose to safety follow-up visit (54 weeks) or early termination]
  2. Incidence of TEAEs leading to discontinuation of study drug [From initial dose to safety follow-up visit (54 weeks) or early termination]

Eligibility Criteria

Ages Eligible for Study 18 Years to 59 Years (Adult)
Sexes Eligible for Study All
Accepts Healthy Volunteers No
Inclusion Criteria
  • Subject is aged ≥18 to <60 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).
Exclusion Criteria
  • Risk for suicidal behavior during the study as determined by the Investigator's clinical assessment and/or Columbia-Suicide Severity Rating Scale (C-SSRS) as confirmed by the following:
  • Subject answers "Yes" to "suicidal ideation" Item 4 (active suicidal ideation with some intent to act, without a specific plan) or Item 5 (active suicidal ideation with a specific plan and intent) on the C-SSRS
  • Non-suicidal self-injurious behavior is not exclusionary
  • Any clinically significant abnormalities, including any finding(s) from ECG, or laboratory test at Visit 6, and the physical examination, vital signs, at the EOT visit of Study KAR-012 that the Investigator, in consultation with the Medical Monitor are considered to jeopardize the safety of the subject
  • Female subject is pregnant
  • If, in the opinion of the Investigator (and/or Sponsor/ Medical Monitor), subject is unsuitable for enrollment in the study or subject has any finding that, in the view of the Investigator (and/or Sponsor /Medical Monitor), may compromise the safety of the subject or affect their ability to adhere to the protocol visit schedule or study requirements
  • Risk of violent or destructive behavior as per Investigator's judgement
  • Subjects participating in another investigational drug or device trial or planning on participating in another clinical trial during the study
  • History or high risk of urinary retention, gastric retention, or narrow angle glaucoma as evaluated by the Investigator
  • Subject is taking, or plans to take while in the study, any prohibited concomitant medication
  • For all male subjects only, any one of the following:
  • History of bladder stones
  • History of recurrent urinary tract infections
  • Serum prostate specific antigen (PSA) >10 ng/mL
  • An International Prostate Symptom Score (IPSS) of 5 (almost always) on either item 1, 3, 5, or 6
  • A sum of scores on IPSS items 1, 3, 5, and 6 of ≥9 Note: IPSS will be required only for male subjects ≥ 45 years of age. Subjects already enrolled in the study who do not have available PSA values from Study KAR-012 for baseline value use in Study CN012-0009, will have these assessments at their next clinic visit planned after re-consenting to determine current eligibility.

Contacts and Locations

Sponsors and Collaborators Karuna Therapeutics
Locations
  • Local Institution - 161 | Phoenix, Arizona, United States, 85012
  • Local Institution - 175 | Little Rock, Arkansas, United States, 72211
  • Woodland International Research Group, LLC | Little Rock, Arkansas, United States, 72211
  • Advanced Research Center, Inc. | Anaheim, California, United States, 92805
  • CITrials - Bellflower | Bellflower, California, United States, 90706
  • Synexus Clinical Research US, Inc. | Cerritos, California, United States, 90703
  • Local Institution - 167 | Culver City, California, United States, 90230
  • Local Institution - 141 | Encino, California, United States, 91436
  • Local Institution - 152 | La Habra, California, United States, 90631
  • Sunwise Clinical Research, LLC. | Lafayette, California, United States, 94549
  • Synergy Clinical Research of Escondido | Lemon Grove, California, United States, 91945
  • CenExel Collaborative Neuroscience Research | Los Alamitos, California, United States, 90720
  • Local Institution - 181 | Oceanside, California, United States, 92056
  • NRC Research Institute | Orange, California, United States, 92868
  • CNRI - Los Angeles, LLC | Pico Rivera, California, United States, 90660
  • CITrials, Inc. - Riverside & San Bernardino County | Riverside, California, United States, 92506
  • Local Institution - 164 | Stanford, California, United States, 94305
  • CenExel Collaborative Neuroscience Research | Torrance, California, United States, 90504
  • Local Institution - 186 | Coral Gables, Florida, United States, 33134
  • Local Institution - 182 | Hialeah, Florida, United States, 33012
  • Galiz Research, LLC | Hialeah, Florida, United States, 33016
  • Local Institution - 173 | Miami Lakes, Florida, United States, 33014
  • Assertive Research Center | Miami Lakes, Florida, United States, 33016
  • Local Institution - 171 | Miami Springs, Florida, United States, 33166
  • Local Institution - 105 | Miami, Florida, United States, 33016
  • Local Institution - 120 | Miami, Florida, United States, 33016
  • Premier Clinical Research Institute, Inc. | Miami, Florida, United States, 33122
  • Local Institution - 124 | Orange City, Florida, United States, 32763
  • Local Institution - 156 | Pembroke Pines, Florida, United States, 33024
  • Interventional Psychiatry of Tampa Bay | Tampa, Florida, United States, 33629
  • Grady Memorial Hospital | Atlanta, Georgia, United States, 30303
  • Synexus Clinical Research US, Inc. | Atlanta, Georgia, United States, 30328
  • Local Institution - 135 | Augusta, Georgia, United States, 30912
  • CenExel iResearch Atlanta | Decatur, Georgia, United States, 30030
  • Local Institution - 169 | Marietta, Georgia, United States, 30060
  • Local Institution - 177 | Chicago, Illinois, United States, 60611
  • Local Institution - 142 | Chicago, Illinois, United States, 60612
  • Uptown Research Institute, LLC | Chicago, Illinois, United States, 60640
  • Local Institution - 139 | Overland Park, Kansas, United States, 66210
  • Local Institution - 154 | Monroe, Louisiana, United States, 71201
  • Local Institution - 166 | Gaithersburg, Maryland, United States, 20877
  • Local Institution - 158 | Boston, Massachusetts, United States, 02114
  • Local Institution - 187 | Boston, Massachusetts, United States, 02118
  • Local Institution - 185 | Worcester, Massachusetts, United States, 01655
  • Local Institution - 184 | Ann Arbor, Michigan, United States, 48105
  • Local Institution - 149 | Grand Rapids, Michigan, United States, 49503
  • Local Institution - 162 | Kalamazoo, Michigan, United States, 49001
  • PsychCare Consultants Research | Saint Louis, Missouri, United States, 63128
  • Local Institution - 178 | Saint Louis, Missouri, United States, 63141
  • Local Institution - 174 | Omaha, Nebraska, United States, 68144
  • Altea Research Institute, Las Vegas | Las Vegas, Nevada, United States, 89102
  • Local Institution - 147 | Las Vegas, Nevada, United States, 89102
  • Local Institution - 104 | New York, New York, United States, 10017
  • Local Institution - 160 | New York, New York, United States, 10035
  • Local Institution - 157 | New York, New York, United States, 10036
  • Psychiatry and Alzheimer's Care of Rochester. PLLC | Rochester, New York, United States, 14623
  • Richmond Behavioral Associates ERG Clinical Research - New York PLLC | Staten Island, New York, United States, 10314
  • Local Institution - 176 | Hickory, North Carolina, United States, 28601
  • Local Institution - 163 | Beachwood, Ohio, United States, 44122
  • Local Institution - 165 | Cincinnati, Ohio, United States, 45219
  • Local Institution - 168 | Garfield Heights, Ohio, United States, 44125
  • Local Institution - 179 | Eugene, Oregon, United States, 97403
  • Community Clinical Research, Inc. | Austin, Texas, United States, 78754
  • Local Institution - 183 | Houston, Texas, United States, 77030
  • Local Institution - 180 | Houston, Texas, United States, 77074
  • University Hills Clinical Research - Irving | Irving, Texas, United States, 75062
  • Pillar Clinical Research, LLC | Richardson, Texas, United States, 75080
  • At Health Texas | Richmond, Texas, United States, 77407
  • Green Mountain Research Institute | Rutland, Vermont, United States, 05701
  • Northwest Clinical Research Center | Bellevue, Washington, United States, 98007
  • Local Institution - 318 | Cherven Bryag, Bulgaria, 5980
  • Local Institution - 311 | Dupnitsa, Bulgaria, 2600
  • Local Institution - 316 | Kardzhali, Bulgaria, 6600
  • Local Institution - 302 | Kazanlak, Bulgaria, 6100
  • Local Institution - 304 | Novi Iskar, Bulgaria, 1282
  • Local Institution - 301 | Pleven, Bulgaria, 5800
  • UMHAT 'Dr. Georgi Stranski', EAD | Pleven, Bulgaria, 5800
  • Local Institution - 314 | Plovdiv, Bulgaria, 4002
  • Local Institution - 321 | Plovdiv, Bulgaria, 4004
  • Local Institution - 313 | Razgrad, Bulgaria, 7200
  • MHAT Dr Ivan Seliminski AD | Sliven, Bulgaria, 8800
  • Local Institution - 305 | Sofia, Bulgaria, 1113
  • Local Institution - 306 | Sofia, Bulgaria, 1202
  • Local Institution - 320 | Sofia, Bulgaria, 1407
  • Local Institution - 309 | Sofia, Bulgaria, 1431
  • Local Institution - 307 | Sofia, Bulgaria, 1510
  • Local Institution - 303 | Sofia, Bulgaria, 1680
  • Local Institution - 317 | Targovishte, Bulgaria, 7700
  • DCC Mladost M - Varna, OOD | Varna, Bulgaria, 9020
  • Local Institution - 310 | Vratsa, Bulgaria, 3000
  • Local Institution - 616 | Guwahati, Assam, India, 781032
  • Local Institution - 607 | Ahmedabad, Gujarat, India, 380008
  • Local Institution - 604 | Ahmedabad, Gujarat, India, 380013
  • Local Institution - 609 | Surat, Gujarat, India, 395001
  • Local Institution - 613 | Vadodara, Gujarat, India, 390021
  • Local Institution - 617 | Belgavi, Karnataka, India, 590001
  • Local Institution - 614 | Mangalore, Karnataka, India, 575003
  • Local Institution - 602 | Mangalore, Karnataka, India, 575018
  • Local Institution - 601 | Mysore, Karnataka, India, 570001
  • Local Institution - 611 | Kozhikode, Kerala, India, 673009
  • Local Institution - 610 | Aurangabad, Maharashtra, India, 431005
  • Local Institution - 603 | Nagpur, Maharashtra, India, 440010
  • Local Institution - 608 | Nashik, Maharashtra, India, 422001
  • Local Institution - 605 | Nashik, Maharashtra, India, 422005
  • Local Institution - 615 | Ajmer, Rajasthan, India, 305001
  • Local Institution - 606 | Rajkot, Rajasthan, India, 360001
  • Local Institution - 612 | Lucknow, Uttar Pradesh, India, 226003
  • Local Institution - 506 | Bialystok, Poland, 15-404
  • Local Institution - 507 | Gdansk, Poland, 80-546
  • Local Institution - 509 | Grudziadz, Poland, 86-300
  • Local Institution - 501 | Kielce, Poland, 25-411
  • Local Institution - 503 | Lodz, Poland, 93-118
  • Local Institution - 505 | Lublin, Poland, 20-109
  • Local Institution - 502 | Siemianowice Śląskie, Poland, 41-100
  • Local Institution - 508 | Suchy Las, Poland, 62-002
  • Local Institution - 504 | Tuszyn, Poland, 95-080
  • Local Institution - 803 | Brasov, Romania, 500123
  • Local Institution - 804 | Bucuresti, Romania, 10825
  • Local Institution - 810 | Bucuresti, Romania, 40874
  • Local Institution - 802 | Bucuresti, Romania, 41914
  • Local Institution - 809 | Bucuresti, Romania, 41914
  • Local Institution - 807 | Bucuresti, Romania, 60222
  • Local Institution - 808 | Craiova, Romania, 200157
  • Local Institution - 801 | Galati, Romania, 800179
  • Local Institution - 806 | Iasi, Romania, 700282
  • Local Institution - 805 | Sibiu, Romania, 550281
  • Local Institution - 402 | Belgrade, Serbia, 11000
  • Local Institution - 403 | Belgrade, Serbia, 11000
  • Local Institution - 405 | Belgrade, Serbia, 11000
  • Local Institution - 413 | Belgrade, Serbia, 11000
  • Local Institution - 417 | Belgrade, Serbia, 11000
  • Local Institution - 404 | Kovin, Serbia, 26220
  • Local Institution - 414 | Kovin, Serbia, 26220
  • Local Institution - 401 | Kragujevac, Serbia, 34000
  • Local Institution - 406 | Kragujevac, Serbia, 34000
  • Local Institution - 408 | Kragujevac, Serbia, 34000
  • University Clinical Center Kragujevac | Kragujevac, Serbia, 34000
  • Local Institution - 415 | Nis, Serbia, 18000
  • Local Institution - 411 | Nis, Serbia, 18202
  • Local Institution - 410 | Novi Knezevac, Serbia, 23330
  • Local Institution - 416 | Novi Knezevac, Serbia, 23330
  • Local Institution - 409 | Vrsac, Serbia, 26300
  • Local Institution - 707 | Bodmin, Cornwall, United Kingdom, PL31 2QN
  • Local Institution - 705 | Brighton, East Sussex, United Kingdom, BN1 9RY
  • Local Institution - 701 | London, Greater London, United Kingdom, SE5 8AZ
  • Local Institution - 706 | Ashton Under Lyne, Lancashire, United Kingdom, OL6 7SR
  • Local Institution - 708 | Oxford, Oxfordshire, United Kingdom, OX3 7JX
  • Local Institution - 704 | Paisley, Renfrewshire, United Kingdom, PA2 7DE
  • Local Institution - 702 | Chertsey, Surrey, United Kingdom, KT16 9AU
  • Local Institution - 703 | Birmingham, West Midlands, United Kingdom, B4 6NH
Investigators

    More Information

    Additional Information

    Additional Relevant MeSH Terms

    • Schizophrenia
    • Schizophrenia Spectrum and Other Psychotic Disorders
    • Mental Disorders