The Effect of Methylphenidate on Non-motor Symptoms and Postural Control in Parkinson's Disease.

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.

Conditions

• Parkinson's Disease

Interventions

DRUG

Methylphenidate

Methylphenidate 10mg tablets will be overencapsulated in gelatin capsules for blinding. Subjects will take 1 capsule three times daily for a total of 7 doses.

DRUG

Methylphenidate

Methylphenidate 20mg three times daily for a total of 7 doses.

DRUG

Placebo 10

Blind gelatin capsule three times daily for a total of 7 doses.

DRUG

Placebo 20

Blind gelatin capsule three times daily for a total of 7 doses

Sponsors & Collaborators

• Fonds de la Recherche en Santé du Québec

  collaborator OTHER_GOV

• Quebec Memory and Motor Skills Disorders Research Center

  collaborator OTHER

• Laval University

  lead OTHER

Principal Investigators

• Philippe Corbeil, PhD · Laval University

• Jaime McDonald, BScPhm · Laval University

• Emmanuelle Pourcher, MD · Québec Memory and Motor Skills Disorders Research Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-12-31

Primary Completion

2011-06-30

Completion

2011-06-30

Countries

• Canada

Study Locations