An Open-label Study to Assess the Long-term Safety, Tolerability, Effectiveness, and Durability of Effect of KarXT in Patients With DSM-5 Diagnosis of Schizophrenia
(PENNANT Trial)

Recruiting in Palo Alto (17 mi)

+4 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Karuna Therapeutics

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?This trial is testing KarXT, a new medication, in people with schizophrenia who aren't doing well on their current treatments. The study will check if KarXT is safe to use over an extended period, if patients can handle it without bad side effects, and if it works well to control their symptoms.

Eligibility Criteria

Inclusion Criteria

A signed informed consent form (ICF) must be provided before any study assessments are performed.

The patient has not required psychiatric hospitalization, acute crisis intervention, or other increase in their level of care due to symptom exacerbation within 4 weeks of screening, and in the opinion of the investigator, is psychiatrically stable to be managed in an outpatient setting.

The patient has a CGI-S score of ≤4 (moderately severe or less) at screening and baseline visits.

+9 more

Exclusion Criteria

Patient is pregnant, lactating, or less than 3 months postpartum.

Patient has tested positive for coronavirus disease 2019 (COVID-19) within 2 weeks of screening and/or baseline or patients who have prolonged symptoms of past infection, long COVID, that, in the opinion of the investigator, may interfere with the interpretation of safety during the study.

You are extremely worried about global pandemics, like COVID-19, and are unable to participate in the study.

+7 more