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Xanomeline and Trospium Chloride Capsules for Schizophrenia

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
SchizophreniaXanomeline and Trospium Chloride Capsules - Drug
Eligibility
18 - 55
All Sexes
What conditions do you have?
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Study Summary

This trial will test the effectiveness of a new medication, KarXT, for people with schizophrenia who haven't responded well to other treatments. The study will last 6 weeks and will compare KarXT to a placebo. The primary objective is to measure the effect of KarXT on symptoms of schizophrenia using the PANSS scale.

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Similar Trials

1
WSE
1
AVP-786
1
NaBen®

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: Week 6

Week 6
Categorical response defined as the proportion of subjects achieving a ≥ 30% improvement in PANSS total score at Week 6
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6
Change from Baseline in Clinical Global Impression-Severity (CGI-S) at Week 6
Change from Baseline in Personal Social Performance (PSP) at Week 6
Change from Baseline in Positive and Negative Syndrome Scale (PANSS) Marder Negative symptom factor score at Week 6
Change from Baseline in Positive and Negative Syndrome Scale (PANSS) Marder Positive symptom factor score at Week 6
Preference of Medication (POM) at Week 6

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Similar Trials

2
WSE
2
AVP-786
2
NaBen®

Side Effects for

KarXT
17%Constipation
17%Nausea
9%Dry mouth
9%Dyspepsia
9%Vomiting
7%Headache
6%Somnolence
3%Akathisia
3%Dizziness
3%Weight increased
3%Tachycardia
2%Gamma-Glutamyltransferase increased
2%Decreased appetite
2%Agitation
2%Hyperhidrosis
2%Insomnia
2%Sedation
2%Diarrhoea
1%Psychotic disorder
This histogram enumerates side effects from a completed 2019 Phase 2 trial (NCT03697252) in the KarXT ARM group. Side effects include: Constipation with 17%, Nausea with 17%, Dry mouth with 9%, Dyspepsia with 9%, Vomiting with 9%.

Trial Design

2 Treatment Groups

Drug: KarXT
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

400 Total Participants · 2 Treatment Groups

Primary Treatment: Xanomeline and Trospium Chloride Capsules · Has Placebo Group · Phase 3

Drug: KarXT
Drug
Experimental Group · 1 Intervention: Xanomeline and Trospium Chloride Capsules · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trospium
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: week 6

Who is running the clinical trial?

Karuna TherapeuticsLead Sponsor
9 Previous Clinical Trials
2,550 Total Patients Enrolled
8 Trials studying Schizophrenia
2,170 Patients Enrolled for Schizophrenia
Ronald Marcus, MDStudy DirectorKaruna Therapeutics
2 Previous Clinical Trials
351 Total Patients Enrolled
1 Trials studying Schizophrenia
280 Patients Enrolled for Schizophrenia

Eligibility Criteria

Age 18 - 55 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a primary diagnosis of schizophrenia established by a comprehensive psychiatric evaluation based on the DSM-5 criteria and confirmed by MINI version 7.0.2.
You have been treated with at least 1 antipsychotic for at least 6 weeks and the dose has been adjusted appropriately (within the label) for at least 6 weeks.
Subjects must be in the midst of a mental health crisis and have not required psychiatric hospitalization, incarceration in prison, acute crisis intervention, or other increase in the level of care due to symptom exacerbation within 8 weeks of Screening.
PANSS score ≥ 70 at Screening (Visit 1) and randomization (Day 1, Visit 3).
Subjects with ≤ 20-point decrease in PANSS Total score between Visit 1 and Visit 3.
References

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