Study of Methylphenidate to Treat Gait Disorders And Attention Deficit In Parkinson's Disease (PARKGAIT-II)
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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 |
- Number of steps on 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 ]
- 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:
|
|
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 |
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| France | |
| Service de Neurologie, Clinique Neurologique, EA 2683, IFR 114 | |
| Lille, France, 59037 | |
| 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 May 16, 2013