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KarXT for Schizophrenia (PENNANT Trial)
PENNANT Trial Summary
This trial is testing a new drug, KarXT, on people with schizophrenia over 3 years to assess safety, effectiveness & durability.
PENNANT Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 3 trial • 252 Patients • NCT04659161PENNANT Trial Design
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Who is running the clinical trial?
Frequently Asked Questions
What is the size of the participant population for this clinical trial?
"Affirmative. Clinicaltrials.gov displays that this research trial, which was initially posted on November 8th 2022, is currently recruiting participants. Approximately 380 patients need to be drawn from 2 distinct medical sites."
Is enrollment for this research endeavor still available?
"Affirmative. The clinical trial is actively seeking participants, which can be seen on the information posted to clinicaltrials.gov from November 8th 2022 and last updated December 1st of the same year. 380 individuals are needed for enrollment at two different sites."
Is the participant base of this research limited to individuals aged twenty or older?
"As stated in the admission requirements, individuals who are 18 years old or older and below 65 can register for this trial."
Has the U.S Food and Drug Administration (FDA) officially sanctioned KarXT?
"KarXT is classified as a safe therapy, with its safety score on our internal scale at 3. This level of security comes from the multiple rounds of data collection confirming efficacy and safety during Phase 3 trials."
What is the core purpose of this investigation?
"According to the sponsor Karuna Therapeutics, the primary objective of this trial is to assess and measure persistance/durability of effect via Investigator Assessment Questionnaire (IAQ) and Clinical Global Impression - Severity of Illness (CGI-S). Other secondary objectives include establishing a Clinical Global Impression - Improvement (CGI-I) score, determining incidence of serious Treatment Emergent Adverse Events (TEAEs), as well as assessing patient satisfaction with Medication Satisfaction Questionnaire(MSQ) over an extended period from initial dose to safety follow up visit lasting up until week 160 or early termination."
Are there any restrictions on who may participate in this clinical research?
"This clinical trial has been authorized to admit 380 patients with schizophrenia aged between 18-65. Participants must meet the following qualifications: Provide informed consent, Have a primary diagnosis of schizophrenia based on DSM 5 (American Psychiatric Association, 2013) criteria and have been under continuous care for at least 6 months prior to entry., No psychiatric hospitalization or increased level of care due to symptoms in last 4 weeks., CGI-S score ≤4 at screening/baseline visits., An oral antipsychotic medication taken daily as per label instructions for past 30 days., A reliable caregiver willing by informed consent to respond ZBI 22 scale at specified visits (if"
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