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

NCT01244269 | Terminated Phase 4

• 1 other identifier: MPH.NMS.2011
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Parkinson's disease; Methylphenidate; Non motor symptoms; Postural control

Outcome Measures

Primary Outcomes (4)

• Conners' Continuous Performance Test-II score

  Baseline, 2 hours following first dose, 2 hours following last dose

• Orthostatic drop - blood pressure in mmHg

  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

  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

  As recorded using dynamic posturography (Sensory Organization Test).

  Baseline, 2 hours following first dose, 2 hours following last dose

Secondary Outcomes (4)

• Visual analog fatigue scale scores

  Baseline, 2 hours following last dose

• Blood pressure (mmHg)

  Baseline, 30, 60, and 90 minutes following first and final dose of study medication

• Heart rate

  Basesline, 30, 60, and 90 minutes following first and final dose of study medication

• Number of errors recorded for 'Backward Digit Span' task

  Baseline, 2 hours following first dose, 2 hours following final dose

Study Arms (4)

Methylphenidate 10

EXPERIMENTAL

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

Drug: Methylphenidate

Placebo 10

PLACEBO COMPARATOR

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

Drug: Placebo 10

Methylpheindate 20

EXPERIMENTAL

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

Drug: Methylphenidate

Placebo 20

PLACEBO COMPARATOR

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

Drug: Placebo 20

Interventions

Methylphenidate 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.

Also known as: Ritalin

Methylphenidate 10

Placebo 10 DRUG

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

Placebo 10

Placebo 20 DRUG

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

Placebo 20

Eligibility Criteria

• Age: Up to 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Laval University: lead
• Fonds de la Recherche en Santé du Québec: collaborator
• Quebec Memory and Motor Skills Disorders Research Center: collaborator

Study Sites (2)

Québec Memory and Motor Skills Disorders Research Center

Québec, Quebec, G1S 2M2, Canada

Location

Laval University

Québec, Quebec, G1V 0A6, Canada

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Philippe Corbeil, PhD

  Laval University

  STUDY DIRECTOR

• Jaime McDonald, BScPhm

  Laval University

  STUDY DIRECTOR

• Emmanuelle Pourcher, MD

  Québec Memory and Motor Skills Disorders Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professeur

Study Record Dates

• First Submitted: November 18, 2010
• First Posted: November 19, 2010
• Study Start: December 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: October 22, 2012

Record last verified: 2012-10

Locations

CA (2)