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Acetylcholine Modulator

KarXT for Schizophrenia (PENNANT Trial)

Phase 3
Waitlist Available
Research Sponsored by Karuna Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from initial dose to end of study visit (up to 160 weeks) or early termination
Awards & highlights

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

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from initial dose to end of study visit (up to 160 weeks) or early termination
This trial's timeline: 3 weeks for screening, Varies for treatment, and from initial dose to end of study visit (up to 160 weeks) or early termination for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of treatment-emergent adverse events (TEAEs) leading to discontinuation
Persistence and durability of effect of KarXT via Investigator Assessment Questionnaire (IAQ) and Clinical Global Impression - Severity of Illness (CGI-S) scores at clinical visits throughout the study
Secondary outcome measures
Clinical Global Impression - Improvement (CGI-I) Score
Incidence of TEAEs of special interest
Incidence of serious TEAEs (TESAEs)
+1 more

Side effects data

From 2022 Phase 3 trial • 252 Patients • NCT04659161
21%
Constipation
19%
Nausea
19%
Dyspepsia
14%
Vomiting
13%
Headache
10%
Hypertension
9%
Dizziness
6%
Abdominal discomfort
6%
Diarrhoea
6%
Gastrooesophageal reflux disease
5%
Somnolence
5%
Dry mouth
5%
Vision blurred
5%
Anxiety
3%
Abdominal pain
3%
Heart rate increased
2%
Insomnia
2%
Suicidal ideation
2%
Orthostatic hypotension
2%
Salivary hypersecretion
2%
Back pain
2%
Agitation
1%
Psychotic disorder
1%
Toothache
100%
80%
60%
40%
20%
0%
Study treatment Arm
KarXT
Placebo

PENNANT Trial Design

1Treatment groups
Experimental Treatment
Group I: KarXTExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Xanomeline and Trospium Chloride Capsules
2021
Completed Phase 3
~850

Find a Location

Who is running the clinical trial?

Karuna TherapeuticsLead Sponsor
12 Previous Clinical Trials
3,402 Total Patients Enrolled
9 Trials studying Schizophrenia
2,322 Patients Enrolled for Schizophrenia

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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"

Answered by AI
~2 spots leftby Apr 2025