A Six-week, Randomized, Double-blind, Placebo-controlled, Parallel Group, Multi-center, Phase II Study

Summary

This is a prospective, six-week, randomized, double blind, placebo-controlled, multi-center study in patients with schizophrenia who are experiencing an acute exacerbation of psychosis.

Timeline

Start

2008-07

Primary completion

2009-07

Completion

2009-09

Outcome

Met primary endpoint

release “BL-1020 meets primary and secondary efficacy endpoints from the phase 2b EAGLE trial” biolinerx.com ↗

release “The Phase IIb EAGLE trial data demonstrate that BL-1020 is effective at treating schizophrenia symptoms with a good safety profile.” biolinerx.com ↗

release “Results of the study shows that BL-1020 was significantly better than the placebo and comparable with Risperidone in both PANSS and CGI scores” biolinerx.com ↗

Publications

• Geffen Y, Keefe R, Rabinowitz J, Anand R, Davidson M. Bl-1020, a new gamma-aminobutyric acid-enhanced antipsychotic: results of 6-week, randomized, double-blind, controlled, efficacy and safety study. J Clin Psychiatry. 2012 Sep;73(9):e1168-74. doi: 10.4088/JCP.12m07642.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	PERPHENAZINE 4-AMINOBUTYRATE	Small molecule	10 mg	—
Subject	PERPHENAZINE 4-AMINOBUTYRATE	Small molecule	20 mg	—
Subject	PERPHENAZINE 4-AMINOBUTYRATE	Small molecule	30 mg	—
Comparator	Risperidone	Other / unclassified	2 mg	—
Comparator	Risperidone	Other / unclassified	8 mg	—

Indications