drugset / Trial / NCT04158687

A Phase 2 Study to Evaluate the Safety and Efficacy of CTP-692 as an Adjunctive Treatment in Adults With Schizophrenia

NCT04158687 ↗

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The objective of this study is to assess the safety and efficacy of 3 different doses of CTP-692 administered once daily (QD) for 12 weeks to adult participants with schizophrenia on stable dopaminergic antipsychotic medication.

Timeline

Start
2019-11-26
Primary completion
2020-12-22
Completion
2020-12-22

Outcome

Missed primary endpoint

registry analysis (superiority test); Placebo vs CTP-692 1 Gram QD; p = 0.6003 NCT04158687 ↗

registry analysis (superiority test); Placebo vs CTP-692 2 Grams QD; p = 0.3920 NCT04158687 ↗

registry analysis (superiority test); Placebo vs CTP-692 4 Grams QD; p = 0.1444 NCT04158687 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject CTP-692 Unknown 1 g Oral
Subject CTP-692 Unknown 2 g Oral
Subject CTP-692 Unknown 4 g Oral

Indications