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Amantadine and L-DOPA-induced Dyskinesia in Early Parkinson's Disease (PREMANDYSK)

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: NCT01538329
Recruitment Status : Unknown
Verified May 2016 by University Hospital, Toulouse.
Recruitment status was:  Recruiting
First Posted : February 24, 2012
Last Update Posted : May 9, 2016
Information provided by (Responsible Party):
University Hospital, Toulouse

Brief Summary:

Traditionally amantadine is used at the beginning of Parkinson Disease (PD) treatment in the early stages of the disease, as a modest antiparkinsonian symptomatic treatment. This treatment is usually maintained for no more than the first few months of management, before resorting to drugs deemed more effective as dopamine agonists and lévo-DOPA (L-DOPA). A more modern use of the drug is at a more advanced stage of PD when dyskinesia are already established and become disabling for the patients. There is no data between these two extremes of life stages of Parkinsonism. However, the mechanisms of action of amantadine and the pathophysiology of the motor complications induced by L-DOPA, in particular dyskinesia suggest that the early and prolonged use of amantadine in the early years of management, before L-DOPA-induced dyskinesia have already emerged, should have a positive impact on long-term occurrence and fate of these symptoms, possibly through a glutamatergic mechanism of brain plasticity-of the "disease modification" type.

The primary purpose of this study is to demonstrate that early introduction of treatment with amantadine (200 mg / d) in the early years of therapeutic care, that is to say during the "honeymoon" of levodopa (early phase of disease <3 years of diagnosis <1 year of L-dopa and lack of complications of levodopa therapy) decreases the rate of subjects with abnormal involuntary dyskinetic movements after 18 months of follow-up.

Condition or disease Intervention/treatment Phase
Parkinson Disease Drug: Amantadine Drug: placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 202 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of Amantadine on L-DOPA-induced Dyskinesia in Early Parkinson's Disease: a Placebo-controlled Randomized Study (the PREMANDYSK Study)
Study Start Date : March 2012
Estimated Primary Completion Date : April 2017
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Amantadine
Patients with amantadine
Drug: Amantadine
200mg / day once daily in the morning and at noon - oral administration -
Other Name: active drug

Placebo Comparator: Placebo
Patients with amantadine placebo
Drug: placebo
200mg / day once daily in the morning and at noon - oral administration -
Other Name: placebo of amantadine

Primary Outcome Measures :
  1. after 18 months of Phase 1 of the study [ Time Frame: after 18 months of follow-up ]
    Rate of patient with abnormal involuntary dyskinetic movements (as specifically defined in the protocol) after 18 months of Phase 1 of the study (amantadine versus placebo).

Secondary Outcome Measures :
  1. abnormal involuntary dyskinetic movements at the end of phase 3 of the study (wash out) [ Time Frame: 22 months after inclusion ]
    Rate of patients with abnormal involuntary dyskinetic movements at the end of phase 3 of the study (wash out)

  2. motor fluctuations after 18 months of Phase 1 of the study [ Time Frame: 18 months after inclusion ]
    Rate of patients with non-motor fluctuations after 18 months of Phase 1 (defined by the specific scale developed by the Marseille team involved in the project)

  3. Time to onset of dyskinesias [ Time Frame: each visits ]
    Time to onset of dyskinesias defined as the study visit at which the investigator answers "yes" for the first time the question "do you think this patient has dyskinesia as defined in Protocol "

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age over 35 years,
  • Patients having signed an informed consent before any specific study procedures,
  • Patients having a health Insurance Coverage (according to local regulatory requirements),
  • Patients suffering from idiopathic Parkinson's disease meeting the definition criteria of the UKPD Brain Bank (Gibb and Lees, 1988),
  • Parkinson's disease diagnosed for <3 years,
  • Patients receiving treatment with L-DOPA from <1year,
  • Lack of complications of levodopa therapy
  • Patients receiving a stable antiparkinsonian treatment that may involve, in addition to L-DOPA, a dopamine agonist, a monoamine oxidase-B (MAO-B) or a catecholamine O-methyl transferase (COMT) inhibitor, an anti-cholinergic for at least 2 months before enrollment and in whom we presume it will be possible to maintain this treatment unchanged during the study period (except the dose of L-dopa which can be adjusted during the study after the third month of Phase 1).

Exclusion Criteria:

  • Atypical parkinsonian syndromes,
  • Drug-induced Parkinsonism,
  • Juvenile Parkinson,
  • Patients with complications of levodopa therapy
  • Inability to keep the current stable antiparkinsonian treatment during the study period, apart from L-DOPA,
  • Pretreatment with amantadine,
  • amantadine counter-indication
  • Neuroleptic treatment,
  • Patients with dementia, Mini Mental Status (MMS) <26,
  • Patient with behavioral disorder, ECMP item ≥ 3
  • Female subjects of childbearing potential without effective contraception

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): NCT01538329

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Contact: Delphine VERNET 33-5 61 77 72 16

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CHG Aix en Provence Recruiting
Aix en Provence, France, 13616
Principal Investigator: François Viallet, MD         
CHU de Bordeaux Recruiting
Bordeaux, France, 33604
Principal Investigator: François Tison, MD         
CH Jean Rougier Recruiting
Cahors, France, 46005
Principal Investigator: Jean-Marc Boulesteix, MD         
CHU Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63003
Principal Investigator: franck Durif, MD         
CHU Dijon Recruiting
Dijon, France, 21079
Principal Investigator: Maurice Giroud, MD         
CHU Lille Recruiting
Lille, France, 59037
Principal Investigator: Alain Destée, MD         
CHU Dupuytren Recruiting
Limoges, France, 87042
Principal Investigator: Frederic Torny, MD         
Hopital Lyon Recruiting
Lyon, France, 69003
Principal Investigator: Emmanuel Broussolle, MD         
Hopital de la Timone Recruiting
Marseille, France, 13385
Principal Investigator: Jean-Philippe Azulay, MD         
CH Montauban Recruiting
Montauban, France, 82013
Principal Investigator: Nicolas Boulloche, MD         
hopital Saint Eloi Recruiting
Montpellier, France, 34295
Principal Investigator: Christian Geny, MD         
CHu de Nantes Recruiting
Nantes, France, 44093
Principal Investigator: Philippe Damier, MD         
CH de Narbonne Recruiting
Narbonne, France, 11108
Principal Investigator: Jany Rey Zermati, MD         
Hopital pitié Salpétriére Recruiting
Paris, France, 75013
Contact: Jean-Christophe Corvol, MD    0142165773   
Principal Investigator: Jean-Christophe Corvol, MD         
Hopital Jean Bernard Recruiting
Poitiers, France, 86021
Principal Investigator: Jean-Luc Houeto, MD         
CH Charles Nicolle Recruiting
Rouen, France, 76031
Principal Investigator: David Maltête, MD         
CHU de Strasbourg Recruiting
Strasbourg, France
Principal Investigator: Christine Tanchant, MD         
CHU de Toulouse Recruiting
Toulouse, France, 31000
Principal Investigator: Olivier Rascol, MD         
Sponsors and Collaborators
University Hospital, Toulouse
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Principal Investigator: Olivier Rascol, MD University Hospital, Toulouse

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Responsible Party: University Hospital, Toulouse Identifier: NCT01538329     History of Changes
Other Study ID Numbers: 11 253 01
First Posted: February 24, 2012    Key Record Dates
Last Update Posted: May 9, 2016
Last Verified: May 2016
Keywords provided by University Hospital, Toulouse:
Early introduced treatment
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Neurologic Manifestations
Signs and Symptoms
Antiparkinson Agents
Anti-Dyskinesia Agents
Antiviral Agents
Anti-Infective Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents