E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Atypical Parkinsonism |
Parkinsonismos Atipicos |
|
E.1.1.1 | Medical condition in easily understood language |
Not typical form of parkinsonism |
Formas atipicas de parkinsonismo |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10034010 |
E.1.2 | Term | Parkinsonism |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To assess the ability to detect in vivo underlying tau pathology in unclassifiable parkinsonism by means of [18F]-FDDNP |
Valorar la capacidad del PET con [18F]-FDDNP de detectar in vivo patología tau subyacente en el parkinsonismo inclasificable |
|
E.2.2 | Secondary objectives of the trial |
To characterise a priori the binding of this PET probe in well-defined and classified cases with atypical parkinsonisms with and without underlying tau pathology |
Caracterizar la captación de este radio-trazador en casos clínicamente definidos de parkinsonismo atípico con y sin patología tau subyacente |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
men and women > 40years old with one of this patologies: -multisystemic atrophia -progressive supranuclear paralysis diagnosis by international criteria -atypical parkinsonism without answer to levodopa treatment and without any diagnosis criteria of atypical parkisonism |
pacientes hombres y mujeres de edad igual o superior a 40 años que cumplan los criterios internacionales de diagnostico clinico de una de las siguientes patologías: - atrofia Multisistemica - Paralisis Supranuclear Progresiva - parkinsonismo atipico sin respuesta al tratamiento con levodopa y que no cumplan ninguno de los criterios diagnosticos de parkinsonismos atipicos |
|
E.4 | Principal exclusion criteria |
patient with parkinson disease and parkisonism one year before dementia symptoms patient with vascular dementia or estructural abnosmalities in RMN or TAC creatinin > 1.5 ULN bilirrubin > 2 x ULN or transaminases > 3 x ULN Previous drugs or alcohol abuse Previous participation in a investigational stydy 30 days before screening |
El sujeto esta diagnosticado de EP y cumple los criterios diagnosticos de la United Kingdom Parkinson Disease Society Brain Bank y ha desarrollado el parkinsonismo un año antes de los sintomas de demencia El sujeto cumple criterios de demencia vascular o presenta anomalias estructurales en RNM o TAC en ganglios basales. El sujeto presenta una afectación renal moderada o severa ( creatinina en suero >1.5 sobre el limite normal El sujeto presenta una afectación hepatica moderada o severa ( bilirrubina > 2 veces el limite superior de rango de normalidad, transaminasas >3 veces el limite superior de rango de normalidad,) El sujeto tiene historia de abuso de drogas o alcohol El sujeto ha participado en un estudio clinico con un producto farmaceutico en investigación en los 30 dias previos al screening y/o radiofarmaceutico en un periodo minimo de 5 vida-media radioactiva antes del screening. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
To assess the ability to detect in vivo underlying tau pathology in unclassifiable parkinsonism by means of [18F]-FDDNP |
Valorar la capacidad del PET con [18F]-FDDNP de detectar in vivo patología tau subyacente en el parkinsonismo inclasificable |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
To characterise a priori the binding of this PET probe in well-defined and classified cases with atypical parkinsonisms with and without underlying tau pathology |
Caracterizar la captación de este radio-trazador en casos clínicamente definidos de parkinsonismo atípico con y sin patología tau subyacente |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
last visit of last participating subject |
se define la finalización del estudio como la última visita del último participante |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |