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New drug combo KarXT tested for Long-Term safety in schizophrenia

NCT ID NCT05304767

Disease control Sponsor: Karuna Therapeutics, Inc., a Bristol Myers Squibb company Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jul 31, 2026 · Updated 2 times

Summary

This study looks at the long-term safety of an investigational drug called KarXT when added to current antipsychotic medications for people with schizophrenia. About 280 adults who completed a previous KarXT study will take the drug for up to 52 weeks. Researchers will track side effects to see if KarXT is safe for extended use.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
KarXT (a combination of xanomeline and trospium chloride)
What this could lead to
If successful, this could show that KarXT is safe to use long-term alongside standard antipsychotics, potentially offering a new option for people with schizophrenia who don't fully respond to current treatments.
What could go wrong
This is an open-label extension study, meaning everyone knows they are getting the drug, which can bias results. It focuses on safety, not effectiveness, and the 52-week duration may not capture very rare or long-term side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

290 people

The number who actually took part.

Started

Mar 2022

Finished

Mar 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Subject is aged ≥18 to \<66 years at the time of randomization of Study KAR-012 2. Subject has successfully completed the treatment period of Study KAR-012 3. Subject has been compliant with the procedures in Study KAR-012 (in the Investigator's judgement) 4. 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. 5. Subject is capable of providing signed Informed Consent Form before any study assessments will be performed 6. Subject resides in a stable living situation, in the opinion of the Investigator 7. 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. 8. 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: 1. 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: 1. 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 2. Non-suicidal self-injurious behavior is not exclusionary 2. 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 3. Female subject is pregnant 4. 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 5. Risk of violent or destructive behavior as per Investigator's judgement 6. Subjects participating in another investigational drug or device trial or planning on participating in another clinical trial during the study 7. History or high risk of urinary retention, gastric retention, or narrow angle glaucoma as evaluated by the Investigator 8. Subject is taking, or plans to take while in the study, any prohibited concomitant medication 9. For all male subjects only, any one of the following: 1. History of bladder stones 2. History of recurrent urinary tract infections 3. Serum prostate specific antigen (PSA) \>10 ng/mL 4. An International Prostate Symptom Score (IPSS) of 5 (almost always) on either item 1, 3, 5, or 6 5. 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.

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Conditions

The condition(s) this trial relates to.

schizophrenia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Schizophrenia

Contacts and locations

Locations

  • Local Institution - 101

    Bellevue, Washington, 98007, United States

  • Local Institution - 103

    Irving, Texas, 75062-2757, United States

  • Local Institution - 104

    New York, New York, 10017, United States

  • Local Institution - 105

    Lauderhill, Florida, 33319-4985, United States

  • Local Institution - 108

    Rochester, New York, 14623, United States

  • Local Institution - 109

    Torrance, California, 90504, United States

  • Local Institution - 110

    Cerritos, California, 90703, United States

  • Local Institution - 111

    Atlanta, Georgia, 30328, United States

  • Local Institution - 112

    Little Rock, Arkansas, 72211, United States

  • Local Institution - 113

    Staten Island, New York, 10314-1607, United States

  • Local Institution - 126

    Lafayette, California, 94549, United States

  • Local Institution - 127

    Garden Grove, California, 92845, United States

  • Local Institution - 128

    Austin, Texas, 78754, United States

  • Local Institution - 129

    St Louis, Missouri, 63128, United States

  • Local Institution - 130

    Bellflower, California, 90706, United States

  • Local Institution - 131

    Lemon Grove, California, 91945-2956, United States

  • Local Institution - 133

    Hialeah, Florida, 33016-1814, United States

  • Local Institution - 136

    Atlanta, Georgia, 30303-3031, United States

  • Local Institution - 138

    Decatur, Georgia, 30030, United States

  • Local Institution - 140

    Rutland, Vermont, 05701, United States

  • Local Institution - 144

    Riverside, California, 92506, United States

  • Local Institution - 145

    Miami, Florida, 33122-1335, United States

  • Local Institution - 146

    Anaheim, California, 92805, United States

  • Local Institution - 148

    Las Vegas, Nevada, 89102, United States

  • Local Institution - 150

    Orange, California, 92868, United States

  • Local Institution - 151

    Chicago, Illinois, 60640, United States

  • Local Institution - 152

    La Habra, California, 90631-3842, United States

  • Local Institution - 153

    Miami Lakes, Florida, 33016, United States

  • Local Institution - 155

    Tampa, Florida, 33629, United States

  • Local Institution - 156

    Pembroke Pines, Florida, 33025, United States

  • Local Institution - 157

    New York, New York, 10036, United States

  • Local Institution - 159

    Richmond, Texas, 77407, United States

  • Local Institution - 160

    New York, New York, 10035, United States

  • Local Institution - 161

    Phoenix, Arizona, 85012, United States

  • Local Institution - 163

    Independence, Ohio, 44131, United States

  • Local Institution - 164

    Stanford, California, 94305, United States

  • Local Institution - 166

    Gaithersburg, Maryland, 20877, United States

  • Local Institution - 167

    Culver City, California, 90230, United States

  • Local Institution - 169

    Marietta, Georgia, 30060, United States

  • Local Institution - 170

    Pico Rivera, California, 90660, United States

  • Local Institution - 171

    Miami, Florida, 33166, United States

  • Local Institution - 172

    Richardson, Texas, 75080, United States

  • Local Institution - 173

    Miami Lakes, Florida, 33014, United States

  • Local Institution - 174

    Omaha, Nebraska, 68144, United States

  • Local Institution - 175

    Little Rock, Arkansas, 72204, United States

  • Local Institution - 176

    Hickory, North Carolina, 28601, United States

  • Local Institution - 178

    St Louis, Missouri, 63141, United States

  • Local Institution - 179

    Eugene, Oregon, 97403, United States

  • Local Institution - 180

    Houston, Texas, 77074, United States

  • Local Institution - 181

    Oceanside, California, 92056, United States

  • Local Institution - 182

    Hialeah, Florida, 33012, United States

  • Local Institution - 186

    Coral Gables, Florida, 33134, United States

  • Local Institution - 187

    Boston, Massachusetts, 02118, United States

  • Local Institution - 188

    Berlin, New Jersey, 08009, United States

  • Local Institution - 190

    Fort Worth, Texas, 76104, United States

  • Local Institution - 192

    Atlanta, Georgia, 30331, United States

  • Local Institution - 250

    Toyoake-shi, Aichi-ken, 470-1168, Japan

  • Local Institution - 253

    Meguro-ku, Tokyo, 1540012, Japan

  • Local Institution - 254

    Karatsu-shi, Saga-ken, 847-0031, Japan

  • Local Institution - 255

    Fukuoka, Fukuoka, 819-0037, Japan

  • Local Institution - 256

    Shinjuku-ku, Tokyo-To, 162-0843, Japan

  • Local Institution - 257

    Shirakawa-shi, Fukushima, 961-0021, Japan

  • Local Institution - 301

    Pleven, 5800, Bulgaria

  • Local Institution - 302

    Kazanlak, Stara Zagora, 6100, Bulgaria

  • Local Institution - 303

    Sofia, 1680, Bulgaria

  • Local Institution - 304

    Novi Iskar, 1282, Bulgaria

  • Local Institution - 305

    Sofia, 1113, Bulgaria

  • Local Institution - 306

    Sofia, Sofia-Grad, 1202, Bulgaria

  • Local Institution - 307

    Sofia, 1510, Bulgaria

  • Local Institution - 308

    Varna, 9020, Bulgaria

  • Local Institution - 309

    Sofia, Sofia-Grad, 1463, Bulgaria

  • Local Institution - 310

    Vratsa, 3000, Bulgaria

  • Local Institution - 311

    Dupnitsa, 2600, Bulgaria

  • Local Institution - 312

    Sliven, 8800, Bulgaria

  • Local Institution - 313

    Razgrad, 7200, Bulgaria

  • Local Institution - 314

    Plovdiv, 4002, Bulgaria

  • Local Institution - 315

    Pleven, 5800, Bulgaria

  • Local Institution - 316

    Kardzhali, 6600, Bulgaria

  • Local Institution - 317

    Targovishte, 7700, Bulgaria

  • Local Institution - 318

    Cherven Bryag, 5980, Bulgaria

  • Local Institution - 319

    Sofia, 1408, Bulgaria

  • Local Institution - 321

    Plovdiv, 4004, Bulgaria

  • Local Institution - 401

    Kragujevac, 34 000, Serbia

  • Local Institution - 402

    Belgrade, 11000, Serbia

  • Local Institution - 403

    Belgrade, 101421, Serbia

  • Local Institution - 404

    Kovin, 306041, Serbia

  • Local Institution - 405

    Belgrade, 11000, Serbia

  • Local Institution - 406

    Kragujevac, 34 000, Serbia

  • Local Institution - 407

    Kragujevac, 34 000, Serbia

  • Local Institution - 408

    Kragujevac, 34 000, Serbia

  • Local Institution - 410

    Novi Kneževac, 23330, Serbia

  • Local Institution - 411

    Gornja Toponica, 705631, Serbia

  • Local Institution - 414

    Kovin, 26220, Serbia

  • Sangenjaya Neurology- Psychosomatic Clinic

    Setagaya-ku, Tokyo, 1540004, Japan

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