ClinicalTrials.gov

History of Changes for Study: NCT01538329
Amantadine and L-DOPA-induced Dyskinesia in Early Parkinson's Disease (PREMANDYSK)
Latest version (submitted February 2, 2021) on ClinicalTrials.gov
  • A study version is represented by a row in the table.
  • Select two study versions to compare. One each from columns A and B.
  • Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
  • Click "Compare" to do the comparison and show the differences.
  • Select a version's Submitted Date link to see a rendering of the study for that version.
  • The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
  • Hover over the "Recruitment Status" to see how the study's recruitment status changed.
  • Study edits or deletions are displayed in red.
  • Study additions are displayed in green.
Study Record Versions
Version A B Submitted Date Changes
1 February 20, 2012 None (earliest Version on record)
2 October 22, 2012 Recruitment Status, Study Status and Contacts/Locations
3 April 16, 2013 Study Status
4 April 30, 2013 Outcome Measures and Study Status
5 November 8, 2013 Study Status
6 July 25, 2014 Study Status
7 February 25, 2015 Arms and Interventions, Study Status and Conditions
8 June 10, 2015 Study Status
9 January 11, 2016 Study Status, Eligibility and Study Description
10 May 6, 2016 Study Status
11 February 2, 2021 Recruitment Status, Study Status, Contacts/Locations, Study Design and Study Description
Comparison Format:

Scroll up to access the controls

Study NCT01538329
Submitted Date:  February 20, 2012 (v1)

Open or close this module Study Identification
Unique Protocol ID: 11 253 01
Brief Title: Amantadine and L-DOPA-induced Dyskinesia in Early Parkinson's Disease (PREMANDYSK)
Official Title: Impact of Amantadine on L-DOPA-induced Dyskinesia in Early Parkinson's Disease: a Placebo-controlled Randomized Study (the PREMANDYSK Study)
Secondary IDs:
Open or close this module Study Status
Record Verification: February 2012
Overall Status: Not yet recruiting
Study Start: March 2012
Primary Completion: March 2015 [Anticipated]
Study Completion: June 2015 [Anticipated]
First Submitted: February 20, 2012
First Submitted that
Met QC Criteria:
February 20, 2012
First Posted: February 24, 2012 [Estimate]
Last Update Submitted that
Met QC Criteria:
February 20, 2012
Last Update Posted: February 24, 2012 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: University Hospital, Toulouse
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
Brief Summary:

Traditionally amantadine is used at the beginning of 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 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:
Open or close this module Conditions
Conditions: Early Parkinson Disease
Keywords: Dyskinesia
L-DOPA
Early introduced treatment
Amantadine
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 202 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Amantadine Drug: Amantadine
200mg / day once daily in the morning and at noon - oral administration -
Placebo Comparator: Placebo Drug: placebo
200mg / day once daily in the morning and at noon - oral administration -
Open or close this module Outcome Measures
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 "
Open or close this module Eligibility
Minimum Age: 35 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Male or Female 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 MAO-B or a 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, MMS <26,
  • Patient with behavioral disorder, ECMP item ≥ 3
  • Female subjects of childbearing potential without effective contraception
Open or close this module Contacts/Locations
Central Contact Person: Delphine VERNET
Telephone: 33-5 61 77 72 16
Email: vernet.d@chu-toulouse.fr
Study Officials: Olivier Rascol, MD
Principal Investigator
University Hospital, Toulouse
Locations: France
CHG Aix en Provence
Aix en Provence, France, 13616
Contact:Principal Investigator: François Viallet, MD
CHU de Bordeaux
Bordeaux, France, 33604
Contact:Principal Investigator: François Tison, MD
CH Jean Rougier
Cahors, France, 46005
Contact:Principal Investigator: Jean-Marc Boulesteix, MD
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63003
Contact:Principal Investigator: franck Durif, MD
CHU Dijon
Dijon, France, 21079
Contact:Principal Investigator: Maurice Giroud, MD
CHU Lille
Lille, France, 59037
Contact:Principal Investigator: Alain Destée, MD
CHU Dupuytren
Limoges, France, 87042
Contact:Principal Investigator: Frederic Torny, MD
Hopital Lyon
Lyon, France, 69003
Contact:Principal Investigator: Emmanuel Broussolle, MD
Hopital de la Timone
Marseille, France, 13385
Contact:Principal Investigator: Jean-Philippe Azulay, MD
CH Montauban
Montauban, France, 82013
Contact:Principal Investigator: Nicolas Boulloche, MD
hopital Saint Eloi
Montpellier, France, 34295
Contact:Principal Investigator: Christian Geny, MD
CHu de Nantes
Nantes, France, 44093
Contact:Principal Investigator: Philippe Damier, MD
CH de Narbonne
Narbonne, France, 11108
Contact:Principal Investigator: Jany Rey Zermati, MD
Hopital pitié Salpétriére
Paris, France, 75013
Contact:Contact: Jean-Christophe Corvol, MD 0142165773 jean-christophe.corvol@psl.aphp.fr
Contact:Principal Investigator: Jean-Christophe Corvol, MD
Hopital Jean Bernard
Poitiers, France, 86021
Contact:Principal Investigator: Jean-Luc Houeto, MD
CH Charles Nicolle
Rouen, France, 76031
Contact:Principal Investigator: David Maltête, MD
CHU de Strasbourg
Strasbourg, France
Contact:Principal Investigator: Christine Tanchant, MD
CHU de Toulouse
Toulouse, France, 31000
Contact:Principal Investigator: Olivier Rascol, MD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

Scroll up to access the controls Scroll to the Study top

U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services