Patient diaries as a clinical endpoint in Parkinson's disease clinical trials.

Abstract:

:Parkinson's disease (PD) is the second most common neurodegenerative disorder with an estimated 4 million patients worldwide. L-dopa is standard, and often initial, therapy for patients with this condition; however, with continued dopaminergic treatment and as the disease progresses, the majority of patients experience complications such as "wearing-off" symptoms, dyskinesias, and other motor complications. These complications may become disabling and profoundly affect quality of life. Treatment modification and combination therapies with L-dopa, dopamine agonists, monoamine oxidase type B inhibitors, and catechol-O-methyltransferase inhibitors are commonly used to manage complications. In recent years regulatory agencies, clinical researchers, and sponsors have widely accepted and utilized changes in "ON" and "OFF" time measured by Patient Hauser Diaries as endpoints for measuring efficacy of therapeutics seeking approval for symptomatic treatment of PD. Successful antiparkinsonian medications have been associated with treatment effects of more than 1 h in either reduction of "OFF" time of increase in "ON" time. Accurate "ON" and "OFF" time registration during clinical studies requires rigorous patient training. Reduced compliance, recall bias and diary fatigue are common problems seen with patient diary reported measures. Electronic diaries may help reducing some of these problems but may be associated with other challenges in large, multicenter studies.

journal_name

CNS Neurosci Ther

authors

Papapetropoulos SS

doi

10.1111/j.1755-5949.2011.00253.x

subject

Has Abstract

pub_date

2012-05-01 00:00:00

pages

380-7

issue

5

eissn

1755-5930

issn

1755-5949

journal_volume

18

pub_type

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