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Study of Methylphenidate to Treat Gait Disorders And Attention Deficit In Parkinson's Disease (PARKGAIT-II)
This study is not yet open for participant recruitment.
Verified by University Hospital, Lille, June 2009
First Received: June 2, 2009   Last Updated: July 20, 2009   History of Changes
Sponsor: University Hospital, Lille
Information provided by: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT00914095
  Purpose

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 Intervention Phase
Parkinson's Disease
Severe Gait Disorders With Freezing
No Dementia
Drug: methylphenidate
Drug: placebo
Phase IV

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
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

Resource links provided by NLM:


Further study details as provided by University Hospital, Lille:

Primary Outcome Measures:
  • Number of steps on the Stand Walk Sit Test [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • number of freezing ont the stand walk sit test [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • time on the stand walk sit test [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • FOG trajectory [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • UPDRS [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • RGSE [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Achiron scale [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • psychiatric interview [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Cardiac examination with ECG and blood pressure [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 88
Study Start Date: September 2009
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
methylphenidate: Active Comparator
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)
placebo: Placebo Comparator
tablets of placebo 3 time a day
Drug: placebo
tablets of placebo 3 times a day

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00914095

Contacts
Contact: David Devos, MD, PhD +33320446752 d-devos@chru-lille.fr
Contact: Francine Niset +33320446752 f-niset@chru-lille.fr

Locations
France
Service de Neurologie, Clinique Neurologique, EA 2683, IFR 114
Lille, France, 59037
Sponsors and Collaborators
University Hospital, Lille
Investigators
Principal Investigator: David Devos, MD, PhD Service de Neurologie, Clinique Neurologique, EA 2683, IFR 114, IMPRT
  More Information

Publications:
Responsible Party: Department of Neurology, EA 2683, IFR 114, IMPRT, CHU de Lille, France ( Dr David Devos / MD, PhD )
Study ID Numbers: 2008-005801-20, CPP 08/58
Study First Received: June 2, 2009
Last Updated: July 20, 2009
ClinicalTrials.gov Identifier: NCT00914095     History of Changes
Health Authority: France: Afssaps - French Health Products Safety Agency

Keywords provided by University Hospital, Lille:
Parkinson's disease
Freezing of Gait
Methylphenidate
Dopamine transporter inhibitor
Noradrenaline

Additional relevant MeSH terms:
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Disease
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Basal Ganglia Diseases
Nervous System Diseases
Methylphenidate
Central Nervous System Diseases
Central Nervous System Stimulants
Brain Diseases
Neurodegenerative Diseases
Pharmacologic Actions
Pathologic Processes
Delirium, Dementia, Amnestic, Cognitive Disorders
Parkinson Disease
Movement Disorders
Mental Disorders
Therapeutic Uses
Dopamine Agents
Parkinsonian Disorders
Dementia
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010