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

NCT ID: NCT01244269

Last Updated: 2012-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2011-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Parkinson's Disease

Keywords

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Parkinson's disease Methylphenidate Non motor symptoms Postural control

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Methylphenidate 10

Methylphenidate 10mg three times daily for a total of 7 doses.

Group Type EXPERIMENTAL

Methylphenidate

Intervention Type DRUG

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.

Placebo 10

Placebo capsule three times daily for a total of 7 doses.

Group Type PLACEBO_COMPARATOR

Placebo 10

Intervention Type DRUG

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

Methylpheindate 20

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

Group Type EXPERIMENTAL

Methylphenidate

Intervention Type DRUG

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

Placebo 20

Placebo capsule three times daily for a total of 7 doses.

Group Type PLACEBO_COMPARATOR

Placebo 20

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

Methylphenidate

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

Intervention Type DRUG

Placebo 10

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

Intervention Type DRUG

Placebo 20

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

Intervention Type DRUG

Other Intervention Names

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Ritalin Ritalin

Eligibility Criteria

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Inclusion Criteria

* Patients with stages 2-3 Parkinson's disease as defined by the Hoehn \&Yahr staging system (Hoehn \&Yahr, 1967).
* Age less than or equal to 75 years.
* Subjects who are willing and able to provide, in writing, informed consent.
* Subjects who are willing and able to be confined to the clinical research unit as required by the protocol and to complete all procedures required on an outpatient basis.

Exclusion Criteria

* Subjects with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies and excluding seasonal allergies).
* Subjects with a history of substance abuse or dependence or a positive urine screen for drugs of abuse.
* A history of regular alcohol consumption exceeding 7 drinks/week for women or 14 drinks/week for men (1 drink = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor) within 6 months of screening.
* Subjects with a documented allergy to methylphenidate or one of the product excipients.
* Subjects with any medical condition affecting drug absorption (e.g. gastrectomy).
* Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication.
* Use of a monoamine oxidase inhibitor or other interacting medication within the preceding 14 days or 5 half-lives (whichever is longer).
* History of sensitivity to heparin or heparin-induced thrombocytopenia.
Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fonds de la Recherche en Santé du Québec

OTHER_GOV

Sponsor Role collaborator

Quebec Memory and Motor Skills Disorders Research Center

OTHER

Sponsor Role collaborator

Laval University

OTHER

Sponsor Role lead

Responsible Party

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Jaime McDonald

Professeur

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Philippe Corbeil, PhD

Role: STUDY_DIRECTOR

Laval University

Jaime McDonald, BScPhm

Role: STUDY_DIRECTOR

Laval University

Emmanuelle Pourcher, MD

Role: PRINCIPAL_INVESTIGATOR

Québec Memory and Motor Skills Disorders Research Center

Locations

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Québec Memory and Motor Skills Disorders Research Center

Québec, Quebec, Canada

Site Status

Laval University

Québec, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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MPH.NMS.2011

Identifier Type: -

Identifier Source: org_study_id