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Acetylcholine Modulator
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)
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ at visit 1, 3, 5 (baseline, week 4, 8), and early termination visit (study day 85)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at visit 1, 3, 5 (baseline, week 4, 8), and early termination visit (study day 85)
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 moreSide effects data
From 2022 Phase 3 trial • 252 Patients • NCT0465916121%
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
3,942 Total Patients Enrolled
10 Trials studying Schizophrenia
2,378 Patients Enrolled for Schizophrenia