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Trial record 7 of 139 for:    AMANTADINE

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.
 
ClinicalTrials.gov 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
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

Tracking Information
First Submitted Date  ICMJE February 20, 2012
First Posted Date  ICMJE February 24, 2012
Last Update Posted Date May 9, 2016
Study Start Date  ICMJE March 2012
Estimated Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 20, 2012)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01538329 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 20, 2012)
  • 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)
  • 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)
  • 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 "
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Amantadine and L-DOPA-induced Dyskinesia in Early Parkinson's Disease
Official Title  ICMJE Impact of Amantadine on L-DOPA-induced Dyskinesia in Early Parkinson's Disease: a Placebo-controlled Randomized Study (the PREMANDYSK Study)
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Parkinson Disease
Intervention  ICMJE
  • Drug: Amantadine
    200mg / day once daily in the morning and at noon - oral administration -
    Other Name: active drug
  • Drug: placebo
    200mg / day once daily in the morning and at noon - oral administration -
    Other Name: placebo of amantadine
Study Arms  ICMJE
  • Experimental: Amantadine
    Patients with amantadine
    Intervention: Drug: Amantadine
  • Placebo Comparator: Placebo
    Patients with amantadine placebo
    Intervention: Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 20, 2012)
202
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2017
Estimated Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01538329
Other Study ID Numbers  ICMJE 11 253 01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Toulouse
Study Sponsor  ICMJE University Hospital, Toulouse
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Olivier Rascol, MD University Hospital, Toulouse
PRS Account University Hospital, Toulouse
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP