POC Study in Partially Responsive Generalized Anxiety Disorder

Phase 2 Terminated 90 enrolled Pfizer

RandomizedParallel-groupTriple-blindTreatment

Summary

This study aims to evaluate whether PF-06372865 is safe and effective in the treatment of sub-optimally controlled symptoms of generalized anxiety disorder during two 4-week treatment periods using a Sequential Parallel Comparison Design (SPCD). The study will use the Hamilton Anxiety Rating Scale (HAM-A) to measure change in symptoms from baseline for two doses of PF-06372865 compared to placebo.

Timeline

Start: 2014-11
Primary completion: 2015-10
Completion: 2015-10

Outcome

Missed primary endpoint

Stopped (Enrollment): “Study recruitment was terminated on 24 June 2015, due to a Pfizer business decision. This study was not terminated for reasons of safety or efficacy”

registry Placebo (Stage 1) vs PF-06372865 7.5 mg (Stage 1); p = 0.784; Least Square (LS) Mean Difference 0.6 (90% CI -2.8 to 3.9) NCT02310568 ↗

Publications

Targum SD, Murphy C, Khan J, Zumpano L, Whitlock M, Simen AA, Binneman B. Audio Recording for Independent Confirmation of Clinical Assessments in Generalized Anxiety Disorder. Innov Clin Neurosci. 2018 Apr 1;15(3-4):37-42.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Darigabat	Small molecule	2.5 mg	Oral
Subject	Darigabat	Small molecule	7.5 mg	Oral