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

This study has been terminated.
(Inadequate enrolment, protocol too challenging for participants, lack of observable benefit after analysis of 6 patients.)
Sponsor:
Collaborators:
Fonds de la Recherche en Santé du Québec
Quebec Memory and Motor Skills Disorders Research Center
Information provided by (Responsible Party):
Jaime McDonald, Laval University
ClinicalTrials.gov Identifier:
NCT01244269
First received: November 18, 2010
Last updated: October 19, 2012
Last verified: October 2012

November 18, 2010
October 19, 2012
December 2010
June 2011   (final data collection date for primary outcome measure)
  • Conners' Continuous Performance Test-II score [ Time Frame: Baseline, 2 hours following first dose, 2 hours following last dose ] [ Designated as safety issue: No ]
  • Orthostatic drop - blood pressure in mmHg [ Time Frame: Baseline, 2 hours following first dose, 2 hours following last dose ] [ Designated as safety issue: No ]
    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.
  • Average speed of center of pressure oscillations [ Time Frame: Baseline, 2 hours following first dose, 2 hours following last dose ] [ Designated as safety issue: No ]
    As recorded using dynamic posturography (Sensory Organization Test).
  • Total area of center of pressure oscillations [ Time Frame: Baseline, 2 hours following first dose, 2 hours following last dose ] [ Designated as safety issue: No ]
    As recorded using dynamic posturography (Sensory Organization Test).
Same as current
Complete list of historical versions of study NCT01244269 on ClinicalTrials.gov Archive Site
  • Visual analog fatigue scale scores [ Time Frame: Baseline, 2 hours following last dose ] [ Designated as safety issue: No ]
  • Blood pressure (mmHg) [ Time Frame: Baseline, 30, 60, and 90 minutes following first and final dose of study medication ] [ Designated as safety issue: Yes ]
  • Heart rate [ Time Frame: Basesline, 30, 60, and 90 minutes following first and final dose of study medication ] [ Designated as safety issue: Yes ]
  • Number of errors recorded for 'Backward Digit Span' task [ Time Frame: Baseline, 2 hours following first dose, 2 hours following final dose ] [ Designated as safety issue: No ]
    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.
Same as current
Not Provided
Not Provided
 
The Effect of Methylphenidate on Non-motor Symptoms and Postural Control in Parkinson's Disease.
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Parkinson's Disease
  • 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 Name: Ritalin
  • Drug: Methylphenidate
    Methylphenidate 20mg three times daily for a total of 7 doses.
    Other Name: Ritalin
  • 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
  • Experimental: Methylphenidate 10
    Methylphenidate 10mg three times daily for a total of 7 doses.
    Intervention: Drug: Methylphenidate
  • Placebo Comparator: Placebo 10
    Placebo capsule three times daily for a total of 7 doses.
    Intervention: Drug: Placebo 10
  • Experimental: Methylpheindate 20
    Methylphenidate 20mg three times daily for a total of 7 doses.
    Intervention: Drug: Methylphenidate
  • Placebo Comparator: Placebo 20
    Placebo capsule three times daily for a total of 7 doses.
    Intervention: Drug: Placebo 20
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
6
June 2011
June 2011   (final data collection date for primary outcome measure)

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.
Both
up to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01244269
MPH.NMS.2011
Not Provided
Jaime McDonald, Laval University
Laval University
  • Fonds de la Recherche en Santé du Québec
  • Quebec Memory and Motor Skills Disorders Research Center
Study Director: Philippe Corbeil, PhD Laval University
Study Director: Jaime McDonald, BScPhm Laval University
Principal Investigator: Emmanuelle Pourcher, MD Québec Memory and Motor Skills Disorders Research Center
Laval University
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP