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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 at visit 1, 3, 5 (baseline, week 4, 8), and early termination visit (study day 85)
Awards & highlights
Pivotal Trial
No Placebo-Only Group

Summary

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.

Eligible Conditions
  • Schizophrenia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at visit 1, 3, 5 (baseline, week 4, 8), and early termination visit (study day 85)
This trial's timeline: 3 weeks for screening, Varies for treatment, and at visit 1, 3, 5 (baseline, week 4, 8), and early termination visit (study day 85) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Clinical Global Impression - Severity of Illness (CGI-S) Scores
Investigator Assessment Questionnaire (IAQ) Scores
The Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Leading to Discontinuation
Secondary study objectives
Clinical Global Impression - Improvement (CGI-I) Score
Medication Satisfaction Questionnaire (MSQ) Score
The Number of Participants With Serious Treatment-Emergent Adverse Events (TESAEs)
+1 more

Side effects data

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

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
~1410

Find a Location

Who is running the clinical trial?

Karuna TherapeuticsLead Sponsor
15 Previous Clinical Trials
3,982 Total Patients Enrolled
10 Trials studying Schizophrenia
2,418 Patients Enrolled for Schizophrenia
~1 spots leftby Nov 2025
Unbiased ResultsWe believe in providing patients with all the options.
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