drugset / Trial / NCT02970292

Efficacy and Safety of Adjunctive Pimavanserin for the Treatment of Schizophrenia (ENHANCE-1)

NCT02970292 ↗

Phase 3 Completed 396 enrolled ACADIA Pharmaceuticals Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

To evaluate the efficacy and safety of adjunctive pimavanserin compared with adjunctive placebo in the treatment of schizophrenia

Timeline

Start
2016-10-26
Primary completion
2019-05-28
Completion
2019-06-25

Outcome

Missed primary endpoint

registry analysis (superiority test); Pimavanserin vs Placebo; p = 0.0940; Difference in MMRM LSMs -2.1 (95% CI -4.5 to 0.4) NCT02970292 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Pimavanserin Small molecule 10 mg Oral
Subject Pimavanserin Small molecule 20 mg Oral
Subject Pimavanserin Small molecule 34 mg Oral

Indications