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Methylphenidate for Non-motor and Postural Symptoms in Parkinson's Disease
NCT01244269Phase 4
Key facts
- Status
- Terminated
- Start
- Dec 2010
- Primary completion
- Jun 2011
- Countries
- 1
- Sponsor
- Université Laval
- Modality
- Small Molecules
- Conditions
- Parkinson's disease (PD)
01
Overview
Phase 4, randomised, double-blind trial of methylphenidate hydrochloride extended-release chewable tablet in Parkinson's disease (PD) (4 arms), sponsored by Université Laval. Primary endpoints: Conners' Continuous Performance Test-II score, Orthostatic drop in blood pressure and 2 more. Started Dec 2010; status: terminated.
02
Design
4 arms- Study design
- RandomizedDouble-blind
Methylphenidate 10
Methylphenidate 10mg three times daily for 7 doses
Placebo 10
Placebo capsule three times daily for 7 doses
Methylphenidate 20
Methylphenidate 20mg three times daily for 7 doses
Placebo 20
Placebo capsule three times daily for 7 doses
03
Who it enrols
Patients with stages 2-3 Parkinson's disease aged 75 or younger, excluding those with significant medical conditions, substance abuse, or use of MAO inhibitors.
04
Endpoints
Primary
Conners' Continuous Performance Test-II score
Orthostatic drop in blood pressure
Average speed of center of pressure oscillations
Total area of center of pressure oscillations
Secondary
Visual analog fatigue scale scores
Blood pressure
Heart rate
Number of errors recorded for 'Backward Digit Span' task
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