Trial intelligence / Profile preview

Buspirone for Anxiety in Parkinson's Disease

NCT02803749Phase 2

Key facts

Status: Completed
Start: Oct 2016
Primary completion: Jan 2019
Countries: 1
Sponsor: University of Rochester
Modality: Small Molecules

Drugs: buspirone
Conditions: anxiety disorder

Overview

Phase 2, randomised, double-blind trial in anxiety disorder comparing Buspirone with Placebo (2 arms). Primary endpoint: Number of Participants Who Fail to Complete the 12-week Study on Study Drug. Started Oct 2016; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

Buspirone
Flexible dosage buspirone (maximum dosage 30 mg twice daily)
Placebo
Flexible dosage placebo

Who it enrols

Patients with idiopathic Parkinson's disease and significant anxiety (PAS >= 14), aged 18 or older. Excludes patients with atypical parkinsonism, significant cognitive impairment (MOCA < 23), dysphagia, or recent use of MAO inhibitors.

Endpoints

Primary

Number of Participants Who Fail to Complete the 12-week Study on Study Drug12 weeks

Secondary

Hamilton Anxiety Rating Scale12 weeks
Number of Responders on HAM-A12 weeks
Patient Global Impressions-Improvement12 weeks
Hospital Anxiety and Depression Scale - Anxiety12 weeks
Unified Dyskinesia Rating Scale12 weeks
Clinical Global Impressions-Improvement12 weeks
Hospital Anxiety and Depression Scale - Depression12 weeks

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