- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01244269
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
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Quebec
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Québec, Quebec, Canada, G1S 2M2
- Quebec Memory and Motor Skills Disorders Research Center
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Québec, Quebec, Canada, G1V 0A6
- Laval University
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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.
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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:
Methylphenidate 20mg three times daily for a total of 7 doses.
Other Names:
|
Placebo Comparator: Placebo 10
Placebo capsule three times daily for a total of 7 doses.
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Blind gelatin capsule three times daily for a total of 7 doses.
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Experimental: Methylpheindate 20
Methylphenidate 20mg three times daily for a total of 7 doses.
|
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:
Methylphenidate 20mg three times daily for a total of 7 doses.
Other Names:
|
Placebo Comparator: Placebo 20
Placebo capsule three times daily for a total of 7 doses.
|
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
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Baseline, 2 hours following first dose, 2 hours following last dose
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Orthostatic drop - blood pressure in mmHg
Time Frame: Baseline, 2 hours following first dose, 2 hours following last dose
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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.
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Baseline, 2 hours following first dose, 2 hours following last dose
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Average speed of center of pressure oscillations
Time Frame: Baseline, 2 hours following first dose, 2 hours following last dose
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As recorded using dynamic posturography (Sensory Organization Test).
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Baseline, 2 hours following first dose, 2 hours following last dose
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Total area of center of pressure oscillations
Time Frame: Baseline, 2 hours following first dose, 2 hours following last dose
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As recorded using dynamic posturography (Sensory Organization Test).
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Baseline, 2 hours following first dose, 2 hours following last dose
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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
|
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Blood pressure (mmHg)
Time Frame: Baseline, 30, 60, and 90 minutes following first and final dose of study medication
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Baseline, 30, 60, and 90 minutes following first and final dose of study medication
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Heart rate
Time Frame: Basesline, 30, 60, and 90 minutes following first and final dose of study medication
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Basesline, 30, 60, and 90 minutes following first and final dose of study medication
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Number of errors recorded for 'Backward Digit Span' task
Time Frame: Baseline, 2 hours following first dose, 2 hours following final dose
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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.
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Baseline, 2 hours following first dose, 2 hours following final dose
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Movement Disorders
- Synucleinopathies
- Neurodegenerative Diseases
- Parkinson Disease
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Dopamine Agents
- Dopamine Uptake Inhibitors
- Central Nervous System Stimulants
- Methylphenidate
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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