Status:
COMPLETED
Study of Methylphenidate to Treat Gait Disorders And Attention Deficit In Parkinson's Disease (PARKGAIT-II)
Lead Sponsor:
University Hospital, Lille
Conditions:
Parkinson's Disease
Gait Disorders, Neurologic
Eligibility:
All Genders
30-80 years
Phase:
PHASE4
Brief Summary
Therapeutic management of gait disorders in very advanced Parkinson's disease (PD) patients can sometimes be disappointing, since dopaminergic drug treatments and subthalamic nucleus (STN) stimulation...
Detailed Description
Overall study duration: 2 years. Planned inclusion period: 12 months. Study duration for individual patients: 4 months and 2 weeks(2 weeks between screening and randomization, 3 months of double-blind...
Eligibility Criteria
Inclusion
- Parkinson's disease of more than 5 years
- Subthalamic nucleus stimulation
- Gait disorders impeding moderately to severely the activities of daily living
- gait disorders including freezing of gait
- able to walk without physical assistance
Exclusion
- Dementia (MMSE \< 27 et score de Mattis \< 130)
- Requiring dopatherapie modification
- Requiring subthalamic stimulation parameters adaptation
- Psychiatric disorders: hallucinations, unstable thymic disorders, psychosis)
- Cardiac disorders: dysrhythmia or unstable arterial hypertension
- Unstable or severe medical illness
- intolerance or contraindication to methylphenidate
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT00914095
Start Date
October 1 2009
End Date
December 1 2011
Last Update
April 24 2012
Active Locations (1)
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1
Service de Neurologie, Clinique Neurologique, EA 2683, IFR 114
Lille, France, 59037