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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille
ClinicalTrials.gov Identifier:
NCT00914095
First received: June 2, 2009
Last updated: April 23, 2012
Last verified: June 2009
  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
Gait Disorders, Neurologic
Dementia
Drug: methylphenidate
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

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:
  • time on the stand walk sit test [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • number of freezing on the 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 ]
  • 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 ]

Enrollment: 69
Study Start Date: October 2009
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: placebo

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT00914095     History of Changes
Other Study ID Numbers: 2008-005801-20, 2008_25/0832, PHRC 2008/1918, A90135-48
Study First Received: June 2, 2009
Last Updated: April 23, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

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

ClinicalTrials.gov processed this record on July 22, 2014