The Effect of Methylphenidate on Non-motor Symptoms and Postural Control in Parkinson's Disease.
Status:
Terminated
Trial end date:
2011-06-01
Target enrollment:
Participant gender:
Summary
This project aims to determine if methylphenidate can improve deficits in attention and
symptoms of orthostatic hypotension, two common non-motor symptoms, in patients with
Parkinson's Disease. This project also seeks to evaluate the effect of methylphenidate on
postural control in these patients, a debilitating motor symptom that places patients at an
increased risk of falling. This study will build on existing data to support a new indication
for the use of methylphenidate in Parkinson's Disease. Using standard and objective
evaluations, this study will quantify the effect of methylphenidate at two doses on attention
levels, orthostatic hypotension, and measures of postural control. Phase I of the study will
compare methylphenidate 10mg three times daily to placebo and Phase II of the study, for
those tolerating the lower dose in Phase I, will compare methylphenidate 20mg three times
daily to placebo. By incorporating two different doses, the study also seeks to determine if
any improvements are dose-related. Secondary endpoints will include safety assessments
(adverse event monitoring and vital signs) performed every 30 minutes following supervised
drug administration. Visual analog scales will be presented to each participant before
treatment and following the final dose of each treatment to assess changes in fatigue. A
secondary task will be added to postural tests to assess the influence of cognitive
processes. It is hypothesized that methylphenidate will demonstrate a significant beneficial
effect on all outcomes. It is projected that objective improvements will be observed
following treatment with methylphenidate at both doses (10 and 20mg three time daily) when
compared to placebo. It is further hypothesized that the effects will be dose-related and
therefore more profound with higher doses.
Phase:
Phase 4
Details
Lead Sponsor:
Laval University
Collaborators:
Fonds de la Recherche en Santé du Québec Quebec Memory and Motor Skills Disorders Research Center