Status:
TERMINATED
The Effect of Methylphenidate on Non-motor Symptoms and Postural Control in Parkinson's Disease.
Lead Sponsor:
Laval University
Collaborating Sponsors:
Fonds de la Recherche en Santé du Québec
Quebec Memory and Motor Skills Disorders Research Center
Conditions:
Parkinson's Disease
Eligibility:
All Genders
Up to 75 years
Phase:
PHASE4
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 p...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01244269
Start Date
December 1 2010
End Date
June 1 2011
Last Update
October 22 2012
Active Locations (2)
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1
Québec Memory and Motor Skills Disorders Research Center
Québec, Quebec, Canada, G1S 2M2
2
Laval University
Québec, Quebec, Canada, G1V 0A6