AMANDYSKEvaluation of the Long-term Effects of Amantadine in Parkinsonian's Suffering From Dyskinesia Induced by Levodopa: Study Randomised Double-blind, Placebo - Cessation of a Chronic Prescription. STUDY AMANDYSK.
mantadix
Synucléinopathies+10
+ Maladies des ganglions de la base
+ Maladies du cerveau
Étude thérapeutique
Résumé
Date de début de l'étude : 1 novembre 2007
Date à laquelle le premier participant a commencé l'étude.The trial will involve the participation of the patients for a period of 3 months each. The two groups of patients to be studied are: * a group who will continue their treatment with Amantadine with no modification to dosage; * a group who will have their dosage of Amantadine progressively replaced over several days with a placebo (with the aim of avoiding a "brutal" withdrawal which has been associated with symptoms of hyperthermia in rare cases in the literature). The trial visits are scheduled as such: * weekly visits for the first 4 weeks, with a telephone call between each visit to assure that the withdrawal from Amantadine causes any problems. * every 2 weeks from week 4 until week 8, with weekly telephone calls in between these visits. * a telephone call in the 10th week followed by an end of study visit in week 12. In the event of an early withdrawal from the trial, and assuming that the patient gives their consent, a complete end of study visit will be performed prior to recommencing open label treatment with Amantadine in progressively increasing doses (100mg every 3 days until the pre-study dose is reached).
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.80 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.De 30 à 80 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
Inclusion Criteria: * Female or Male Patients with Idiopathic Parkinson's disease * Presenting peak dose dyskinesias under levodopa therapy * Patient receiving Amantadine for dyskinesia at a dose greater or equal to 200 mg/day (minimum dose at which one can observe anti dyskinetic effects) for at least 6 months. * Patients between 30 and 80 years of age * Patients having reported a subjective amelioration in their dyskinesias under Amantadine (at the beginning of their treatment with same) * Patient with a Mini- Mental State Exam score \> 24 * Patient not presenting a cognitive problem that could impair the comprehension of the patient and their participation in the protocol (patient diaries) * Receiving an anti-parkinsonian treatment at a stable dose for at least 2 months with the expectation that the treatment will remain unchanged throughout the course of the patients participation in the trial. * Signed informed consent obtained * Patient eligible for social security (specific requirement under french law) Exclusion Criteria: * Atypical parkinsonian syndrome (progressive supranuclear palsy, multi-system atrophy, etc) * Patient with parkinsonian syndrome secondary to medication * Patients presenting with dyskinesias whose severity allow an insufficient margin for observing any aggravation which follows a potential withdrawal of treatment (UPDRS 32+33 \>6) * Patients receiving treatment with Apokinon© injector pens (unless that treatment enters into a therapeutic schema at fixed hours) * Patient presenting with dementia or an evolving dopaminergic psychosis * Patient receiving neuroleptics or anticholinesterases * Patients having received functional surgery for their Parkinsons' Disease * Patients pregnant or at risk of same * Patients who are: wards of the state requirement under french law).
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.2 groupes d'intervention sont désignés dans cette étude
50% de chances d'être dans le groupe placebo en aveugle
Groupes de traitement
Groupe I
Comparateur actifGroupe II
PlaceboObjectifs de l'étude
Objectifs principaux
Objectifs secondaires
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 5 sites
CHU de Clermont-Ferrand
Clermont-Ferrand, FranceCHU Timone
Marseille, FranceHôpital Haut-Lévêque
Nantes, France