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Study of Methylphenidate to Treat Gait Disorders And Attention Deficit In Parkinson's Disease (PARKGAIT-II) (PARKGAIT-II)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00914095
Recruitment Status : Completed
First Posted : June 4, 2009
Last Update Posted : April 24, 2012
Information provided by (Responsible Party):
University Hospital, Lille

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 are more effective for limb-related Parkinsonian signs than for gait disorders. Gait disorders could be also partly related to noradrenergic system impairment, pharmacological modulation of both dopamine and noradrenaline pathways could potentially improve the symptomatology. The investigators have demonstrated using an open label study on 17 advanced PD patients that chronic, high doses of methylphenidate (MPD) improved gait, freezing of gait, motor symptoms and attention in the absence of L-Dopa and increased the intensity of response of these symptoms to L-Dopa (Devos et al., 2007). The investigators aimed to confirm their results using a randomized, double-blind, placebo-controlled, parallel-group, multicentric trial. The investigators will assess the clinical value of chronic, high doses (1 mg/kg/day) of MPD vs placebo in 88 non demented PD patients suffering from severe gait disorders with freezing despite their use of optimal dopaminergic doses and eventually STN stimulation parameters. Efficacy will be assessed directly and on video in the absence of L-Dopa and again after acute administration of the drug, both before and after a 3-month course of MPD, using Stand Walk Sit test (primary criteria), the "Freezing Of Gait trajectory", RGSE scale, the UPDRS scores, the dyskinesia rating scale, Achiron scales and using auto-questionnaires of Giladi, ABC scale and PDQ 39. Attention will be assessed using reactions times. Drowsiness will be assessed using Epworth and Parkinson's disease Sleep Scales. Apathy and depression will be monitored with Lille Apathy Rating Scale, MADRS, BPRS, MINI and psychiatric interview. Cardiologic and general tolerance will be also monitored. This study could lead to propose methylphenidate with a good efficacy/ risk balance in advanced PD patients suffering from severe gait disorders with freezing of gait, drowsiness and attention deficit.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Gait Disorders, Neurologic Dementia Drug: methylphenidate Drug: placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study of Methylphenidate to Treat Gait Disorders And Attention Deficit In Parkinson's Disease: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicentric Trial
Study Start Date : October 2009
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Arm Intervention/treatment
Active Comparator: methylphenidate
methylphenidate 10 mg tablets (1 mg /kg /day) 3 time a day
Drug: methylphenidate
10 mg tablet of methylphenidate 3 times a day (1 mg/kg/day)
Other Names:
  • Concerta
  • Ritaline

Placebo Comparator: placebo
tablets of placebo 3 time a day
Drug: placebo
tablets of placebo 3 times a day

Primary Outcome Measures :
  1. Number of steps on the Stand Walk Sit Test [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. time on the stand walk sit test [ Time Frame: 3 months ]
  2. number of freezing on the FOG trajectory [ Time Frame: 3 months ]
  3. UPDRS [ Time Frame: 3 months ]
  4. RGSE [ Time Frame: 3 months ]
  5. psychiatric interview [ Time Frame: 3 months ]
  6. Cardiac examination with ECG and blood pressure [ Time Frame: 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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 Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00914095

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Service de Neurologie, Clinique Neurologique, EA 2683, IFR 114
Lille, France, 59037
Sponsors and Collaborators
University Hospital, Lille
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Principal Investigator: David Devos, MD, PhD Service de Neurologie, Clinique Neurologique, EA 2683, IFR 114, IMPRT
Publications automatically indexed to this study by Identifier (NCT Number):

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Responsible Party: University Hospital, Lille Identifier: NCT00914095    
Other Study ID Numbers: 2008-005801-20
2008_25/0832 ( Other Identifier: sponsor )
PHRC 2008/1918 ( Other Identifier: DHOS )
A90135-48 ( Other Identifier: AFSSAPS )
First Posted: June 4, 2009    Key Record Dates
Last Update Posted: April 24, 2012
Last Verified: June 2009
Keywords provided by University Hospital, Lille:
Parkinson's disease
Freezing of Gait
Dopamine transporter inhibitor
Additional relevant MeSH terms:
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Parkinson Disease
Gait Disorders, Neurologic
Nervous System Diseases
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Neurologic Manifestations
Signs and Symptoms
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents