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
Sinucleinopatías+7
+ Enfermedades del Sistema Nervioso Central
+ Enfermedades de los Ganglios Basales
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de noviembre de 2007
Fecha en la que se inscribió al primer participante.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).
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 80 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.De 30 a 80 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
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 Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.2 grupos de intervención están designados en este estudio
50% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
Comparador ActivoGrupo II
PlaceboObjetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene 5 ubicaciones
CHU de Clermont-Ferrand
Clermont-Ferrand, FranceCHU Timone
Marseille, FranceHôpital Haut-Lévêque
Nantes, France