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

October 19, 2012 updated by: Jaime McDonald, Laval University

Two-phase Randomized Controlled Trial of Low and Moderate Dose Methylphenidate for Non-motor and Postural Symptoms in Parkinson's Disease.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Québec, Quebec, Canada, G1S 2M2
        • Quebec Memory and Motor Skills Disorders Research Center
      • Québec, Quebec, Canada, G1V 0A6
        • Laval University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Methylphenidate 10
Methylphenidate 10mg three times daily for a total of 7 doses.
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.
Other Names:
  • Ritalin
Drug: Methylphenidate
Methylphenidate 20mg three times daily for a total of 7 doses.
Other Names:
  • Ritalin
Placebo Comparator: Placebo 10
Placebo capsule three times daily for a total of 7 doses.
Drug: Placebo 10
Blind gelatin capsule three times daily for a total of 7 doses.
Experimental: Methylpheindate 20
Methylphenidate 20mg three times daily for a total of 7 doses.
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.
Other Names:
  • Ritalin
Drug: Methylphenidate
Methylphenidate 20mg three times daily for a total of 7 doses.
Other Names:
  • Ritalin
Placebo Comparator: Placebo 20
Placebo 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Conners' Continuous Performance Test-II score
Time Frame: Baseline, 2 hours following first dose, 2 hours following last dose
Baseline, 2 hours following first dose, 2 hours following last dose
Orthostatic drop - blood pressure in mmHg
Time Frame: Baseline, 2 hours following first dose, 2 hours following last dose
Blood pressure will be measured following 5 minutes of rest in a lying position and again 1, 3, and 5 minutes after rising to a standing position. The orthostatic drop will be calculated by subtracting the blood pressures recorded at each time interval(1, 3, and 5 minutes after standing) from the blood pressure recorded in a lying position.
Baseline, 2 hours following first dose, 2 hours following last dose
Average speed of center of pressure oscillations
Time Frame: Baseline, 2 hours following first dose, 2 hours following last dose
As recorded using dynamic posturography (Sensory Organization Test).
Baseline, 2 hours following first dose, 2 hours following last dose
Total area of center of pressure oscillations
Time Frame: Baseline, 2 hours following first dose, 2 hours following last dose
As recorded using dynamic posturography (Sensory Organization Test).
Baseline, 2 hours following first dose, 2 hours following last dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual analog fatigue scale scores
Time Frame: Baseline, 2 hours following last dose
Baseline, 2 hours following last dose
Blood pressure (mmHg)
Time Frame: Baseline, 30, 60, and 90 minutes following first and final dose of study medication
Baseline, 30, 60, and 90 minutes following first and final dose of study medication
Heart rate
Time Frame: Basesline, 30, 60, and 90 minutes following first and final dose of study medication
Basesline, 30, 60, and 90 minutes following first and final dose of study medication
Number of errors recorded for 'Backward Digit Span' task
Time Frame: Baseline, 2 hours following first dose, 2 hours following final dose
Following administration of the Backward Digit Span assessment of the Wechsler Adult Intelligence Scale to control for individual capacities, each subject will be provided with a string of digits before the onset of 50% of the trials in the postural test. Subjects will be required to memorize the string of digits in reverse and repeat them at the end of the trial. Errors will be quantified as either errors of insertion, deletion, or order.
Baseline, 2 hours following first dose, 2 hours following final dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laval University

Collaborators

Fonds de la Recherche en Santé du Québec
Quebec Memory and Motor Skills Disorders Research Center

Investigators

  • Study Director: Jaime McDonald, BScPhm, Laval University
  • Principal Investigator: Emmanuelle Pourcher, MD, Quebec Memory and Motor Skills Disorders Research Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

November 18, 2010

First Submitted That Met QC Criteria

November 18, 2010

First Posted (Estimate)

November 19, 2010

Study Record Updates

Last Update Posted (Estimate)

October 22, 2012

Last Update Submitted That Met QC Criteria

October 19, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MPH.NMS.2011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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