An Extension Study to Assess Long-Term Safety and Tolerability of Adjunctive KarXT in Subjects With Inadequately Controlled Symptoms of Schizophrenia

Recruiting Phase 3 Interventional Study
Schizophrenia
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 65
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
280 (estimated)
Sponsor
Karuna Therapeutics, Inc., a Bristol Myers Squibb company · Industry
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About This Trial
This is a Phase 3, multicenter, 52-week, outpatient, open-label extension (OLE) study to evaluate the long-term safety and tolerability of adjunctive KarXT in subjects with schizophrenia with an inadequate response to their current antipsychotic treatment who previously completed the treatment period (Visit 8/Day 42 ± 3) of ARISE Study (KAR-012). The primary objective of the study is to assess the…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Subject is aged ≥18 to \<66 years at the time of randomization of Study KAR-012 2. Subject has successfully completed the treatment period of Study KAR-012 3. Subject has been compliant with the procedures in Study KAR-012 (in the Investigator's judgement) 4. Subject has been…
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