AzTrials
AzTrials

SchizophreniaPhase 3NCT05304767

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

A Phase 3 study testing Xanomeline and Trospium Chloride Capsules in people with Schizophrenia, run by Karuna Therapeutics, Inc., a Bristol Myers Squibb company at 94 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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 ±… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Schizophrenia
What is being tested?
Xanomeline and Trospium Chloride Capsules
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
290 participants
Where
94 sitesin 4 countries
Study dates
7 Mar 2022to 25 Mar 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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
Show all 16Show fewer
  • 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.

Trial locations and contacts

94 sites in 4 countries.

94 sites in 4 countries

United States56 sites

  • Local Institution - 146

    Anaheim, California, 92805

  • Local Institution - 136

    Atlanta, Georgia, 30303-3031

  • Local Institution - 111

    Atlanta, Georgia, 30328

  • Local Institution - 192

    Atlanta, Georgia, 30331

  • Local Institution - 128

    Austin, Texas, 78754

  • Local Institution - 101

    Bellevue, Washington, 98007

  • Local Institution - 130

    Bellflower, California, 90706

  • Local Institution - 188

    Berlin, New Jersey, 08009

  • Local Institution - 187

    Boston, Massachusetts, 02118

  • Local Institution - 110

    Cerritos, California, 90703

  • Local Institution - 151

    Chicago, Illinois, 60640

  • Local Institution - 186

    Coral Gables, Florida, 33134

  • Local Institution - 167

    Culver City, California, 90230

  • Local Institution - 138

    Decatur, Georgia, 30030

  • Local Institution - 179

    Eugene, Oregon, 97403

  • Local Institution - 190

    Fort Worth, Texas, 76104

  • Local Institution - 166

    Gaithersburg, Maryland, 20877

  • Local Institution - 127

    Garden Grove, California, 92845

  • Local Institution - 182

    Hialeah, Florida, 33012

  • Local Institution - 133

    Hialeah, Florida, 33016-1814

  • Local Institution - 176

    Hickory, North Carolina, 28601

  • Local Institution - 180

    Houston, Texas, 77074

  • Local Institution - 163

    Independence, Ohio, 44131

  • Local Institution - 103

    Irving, Texas, 75062-2757

  • Local Institution - 152

    La Habra, California, 90631-3842

  • Local Institution - 126

    Lafayette, California, 94549

  • Local Institution - 148

    Las Vegas, Nevada, 89102

  • Local Institution - 105

    Lauderhill, Florida, 33319-4985

  • Local Institution - 131

    Lemon Grove, California, 91945-2956

  • Local Institution - 175

    Little Rock, Arkansas, 72204

  • Local Institution - 112

    Little Rock, Arkansas, 72211

  • Local Institution - 169

    Marietta, Georgia, 30060

  • Local Institution - 145

    Miami, Florida, 33122-1335

  • Local Institution - 171

    Miami, Florida, 33166

  • Local Institution - 173

    Miami Lakes, Florida, 33014

  • Local Institution - 153

    Miami Lakes, Florida, 33016

  • Local Institution - 104

    New York, New York, 10017

  • Local Institution - 160

    New York, New York, 10035

  • Local Institution - 157

    New York, New York, 10036

  • Local Institution - 181

    Oceanside, California, 92056

  • Local Institution - 174

    Omaha, Nebraska, 68144

  • Local Institution - 150

    Orange, California, 92868

  • Local Institution - 156

    Pembroke Pines, Florida, 33025

  • Local Institution - 161

    Phoenix, Arizona, 85012

  • Local Institution - 170

    Pico Rivera, California, 90660

  • Local Institution - 172

    Richardson, Texas, 75080

  • Local Institution - 159

    Richmond, Texas, 77407

  • Local Institution - 144

    Riverside, California, 92506

  • Local Institution - 108

    Rochester, New York, 14623

  • Local Institution - 140

    Rutland, Vermont, 05701

  • Local Institution - 129

    St Louis, Missouri, 63128

  • Local Institution - 178

    St Louis, Missouri, 63141

  • Local Institution - 164

    Stanford, California, 94305

  • Local Institution - 113

    Staten Island, New York, 10314-1607

  • Local Institution - 155

    Tampa, Florida, 33629

  • Local Institution - 109

    Torrance, California, 90504

Other trials in United States

Bulgaria20 sites

  • Local Institution - 318

    Cherven Bryag, 5980

  • Local Institution - 311

    Dupnitsa, 2600

  • Local Institution - 316

    Kardzhali, 6600

  • Local Institution - 302

    Kazanlak, Stara Zagora, 6100

  • Local Institution - 304

    Novi Iskar, 1282

  • Local Institution - 301

    Pleven, 5800

  • Local Institution - 315

    Pleven, 5800

  • Local Institution - 314

    Plovdiv, 4002

  • Local Institution - 321

    Plovdiv, 4004

  • Local Institution - 313

    Razgrad, 7200

  • Local Institution - 312

    Sliven, 8800

  • Local Institution - 306

    Sofia, Sofia-Grad, 1202

  • Local Institution - 309

    Sofia, Sofia-Grad, 1463

  • Local Institution - 305

    Sofia, 1113

  • Local Institution - 319

    Sofia, 1408

  • Local Institution - 307

    Sofia, 1510

  • Local Institution - 303

    Sofia, 1680

  • Local Institution - 317

    Targovishte, 7700

  • Local Institution - 308

    Varna, 9020

  • Local Institution - 310

    Vratsa, 3000

Other trials in Bulgaria

Serbia11 sites

  • Local Institution - 403

    Belgrade, 101421

  • Local Institution - 402

    Belgrade, 11000

  • Local Institution - 405

    Belgrade, 11000

  • Local Institution - 411

    Gornja Toponica, 705631

  • Local Institution - 414

    Kovin, 26220

  • Local Institution - 404

    Kovin, 306041

  • Local Institution - 401

    Kragujevac, 34 000

  • Local Institution - 406

    Kragujevac, 34 000

  • Local Institution - 407

    Kragujevac, 34 000

  • Local Institution - 408

    Kragujevac, 34 000

  • Local Institution - 410

    Novi Kneževac, 23330

Other trials in Serbia

Japan7 sites

  • Local Institution - 255

    Fukuoka, Fukuoka, 819-0037

  • Local Institution - 254

    Karatsu-shi, Saga-ken, 847-0031

  • Local Institution - 253

    Meguro-ku, Tokyo, 1540012

  • Sangenjaya Neurology- Psychosomatic Clinic

    Setagaya-ku, Tokyo, 1540004

  • Local Institution - 256

    Shinjuku-ku, Tokyo-To, 162-0843

  • Local Institution - 257

    Shirakawa-shi, Fukushima, 961-0021

  • Local Institution - 250

    Toyoake-shi, Aichi-ken, 470-1168

Other trials in Japan

About this study

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

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.

Conditions
Schizophrenia
Being tested
Xanomeline and Trospium Chloride Capsules
Medical subject headings
Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Xanomeline and Trospium Chloride CapsulesDrug

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

Study groups in NCT05304767
Study groupRoleWhat they receive
Drug: KarXTExperimentalNot described
Receives: Drug: Xanomeline and Trospium Chloride Capsules

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of treatment-emergent adverse events (TEAEs)

    Measured: From initial dose to safety follow-up visit (54 weeks) or early termination

Secondary outcomes (2)

  1. Incidence of serious treatment-emergent adverse events (TEAEs)

    Measured: From initial dose to safety follow-up visit (54 weeks) or early termination

  2. Incidence of TEAEs leading to discontinuation of study drug

    Measured: From initial dose to safety follow-up visit (54 weeks) or early termination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Mar 2022
  2. Study start7 Mar 2022
  3. Primary completion25 Mar 2026
  4. Study completion25 Mar 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
290 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05304767
Sponsor's protocol ID
CN012-0009
Other IDs
CN012-0009, KAR-013
Status last verified
Jul 2026
First submitted
21 Mar 2022
Last updated
31 Jul 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Xanomeline and Trospium Chloride Capsules in people with Schizophrenia, run by Karuna Therapeutics, Inc., a Bristol Myers Squibb company at 94 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 94 sites in United States, Bulgaria, Serbia, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of treatment-emergent adverse events (TEAEs) (time frame: From initial dose to safety follow-up visit (54 weeks) or early termination). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05304767.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in