Trial intelligence / Profile preview

Donepezil for Falls in Parkinson's Disease

NCT00912808Phase 2

Key facts

Status
Completed
Start
Oct 2005
Primary completion
Feb 2009
Sponsor
Oregon Health & Science University
Modality
Small Molecules
Conditions
Parkinson's disease (PD)
01

Overview

Phase 2, randomised, double-blind trial of donepezil in Parkinson's disease (PD) (2 arms), sponsored by Oregon Health & Science University. Primary endpoint: Fall Frequency Per Day at 6 weeks. Started Oct 2005; status: completed.

02

Design

2 arms
Study design
RandomizedDouble-blind
  • Donepezil -> Placebo

    Subjects receive Donepezil in Period 1 and Placebo in Period 2

  • Placebo -> Donepezil

    Subjects receive Placebo in Period 1 and Donepezil in Period 2

03

Who it enrols

Adults >21 with Parkinson's disease treated with dopaminergic medication for at least 1 year, who are ambulatory but report frequent falls (>2/week). Excludes those with dementia (MMSE < 25), non-CNS causes of falls, or use of Warfarin or cholinergic/anticholinergic meds.

04

Endpoints

Primary

  • Fall Frequency Per Day

Secondary

  • Frequency of Near Falls Per Day

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