Efficacy and Safety of Pimavanserin as Adjunctive Treatment for the Negative Symptoms of Schizophrenia

NCT04531982 ↗

Phase 3 Completed 454 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 negative symptoms of schizophrenia

Timeline

Start: 2020-08-05
Primary completion: 2024-01-25
Completion: 2024-02-19

Outcome

Missed primary endpoint

registry analysis (superiority test); Drug - Pimavanserin vs Placebo; p = 0.4825; Mixed Models Analysis; note: Two-sided p-value for treatment difference at Week 26 from MMRM analysis. NCT04531982 ↗

release “Phase 3 ADVANCE-2 trial evaluating pimavanserin for the treatment of negative symptoms of schizophrenia. Pimavanserin did not demonstrate a statistically significant” acadia.com ↗

Publications

Darwish M, Bugarski-Kirola D, Passarell J, Owen J, Jaworowicz D, DeKarske D, Stankovic S. Pimavanserin Exposure-Response Analyses in Patients With Schizophrenia: Results From the Phase 2 ADVANCE Study. J Clin Psychopharmacol. 2022 Nov-Dec 01;42(6):544-551. doi: 10.1097/JCP.0000000000001611. Epub 2022 Oct 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pimavanserin	Small molecule	34 mg	Oral