Relapse Prevention Trial Evaluating KarXT Treatment in Schizophrenia

ConditionSchizophrenia
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorKaruna Therapeutics, Inc., a Bristol Myers Squibb company

About this trial

The purpose of the study is to evaluate the relapse prevention of KarXT in the treatment of participants with Schizophrenia

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participant must have a primary diagnosis of schizophrenia for at least 1 year established by a comprehensive psychiatric evaluation based on the DSM-5-TR (American Psychiatric Association 2022) criteria and confirmed by MINI for Psychotic Disorder Studies version 7.0.2 at screening.

Participant must have experienced hospitalization for schizophrenia within 1 year from the screening date.

Participant must be experiencing residual schizophrenia symptoms and have a PANSS total score ≥70 to ≤ 110 at screening and Day -1.

Item 1 (P1; delusions)

Disqualifiers

Participant must not have any primary DSM-5 disorder other than schizophrenia within 12 months before screening

Participants must not have a newly diagnosed or are experiencing their first treated episode of psychosis or schizophrenia.

Participant must not have a risk of suicidal behavior as determined by the Investigator's clinical assessment and/or Columbia-suicide Severity Rating Scale (C-SSRS).

Participant must not have had psychiatric hospitalization(s) for more than 30 days (cumulative) within the 6 months before screening.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Xanomeline/Trospium Chloride

    Drug

    Specified dose on specified days

  • Placebo

    Drug

    Specified dose on specified days

Treatment groups

472 Participants
are divided into 2 treatment groups
Group A: KarXTExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Time From Randomization to the First Relapse Event

Time frame
Up to approximately Week 43

Secondary outcomes

1

Time to Discontinuation During Double-blind Treatment Period

Time frame
Approximately From Week 18 to 43
2

Number of Participants With Treatment Emergent Adverse Events (TEAEs)

Time frame
Up to approximately Week 45
3

Number of Participants With Adverse Events of Special Interest (AESIs)

Time frame
Up to approximately Week 45
4

Number of Participants With Procholinergic Symptoms

Time frame
Up to approximately Week 45

Other outcomes

Sponsors and contacts

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