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統合失調症の症状が十分にコントロールされていない被験者における補助的KarXTの有効性と安全性を評価する研究

基本情報

NCT ID
NCT05145413
ステータス
完了
試験のフェーズ
第3相
試験タイプ
介入
目標被験者数
396
治験依頼者名
Karuna Therapeutics

概要

This is a Phase 3, 6-week, randomized, double-blind, placebo-controlled, multicenter, outpatient study in subjects with schizophrenia with an inadequate response to their current atypical antipsychotic treatment. The primary objective of the study is to assess the efficacy of adjunctive KarXT (a fixed dose combination of xanomeline and trospium chloride twice daily \[BID\]) versus placebo in the treatment of subjects with inadequately controlled symptoms of schizophrenia as measured by the Positive and Negative Syndrome Scale (PANSS) Total Score.

対象疾患

Schizophrenia

介入

Xanomeline and Trospium Chloride Capsules(DRUG)
Placebo(DRUG)

依頼者(Sponsor)