E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Syndrome Gilles de la Tourette's disease Parkinosn Pounding |
Sindrome di Gilles de la Tourette, Pounding nella malattia di Parkinosn |
|
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 | LLT |
E.1.2 | Classification code | 10013113 |
E.1.2 | Term | Disease Parkinson's |
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 |
demonstrate the clinical efficacy of long-term treatment with finasteride in patients with Tourette's disease \ m Parkinson's |
dimostrare l’efficacia clinica del trattamento a lungo termine con finasteride nei pazienti affetti da malattia di Tourette\m di Parkinson |
|
E.2.2 | Secondary objectives of the trial |
to evaluate the safety levels of the drug in such patients as similar to those expected for the categories for which the drug is already in use |
valutare i livelli di safety del farmaco in questa categoria di pazienti attesi come sovrapponibili a quelli per le categorie per cui il farmaco e' gia' in uso |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients of both sexes, aged between 18 and 65 years with Gilles de la Tourette syndrome, patients with compulsive behavior (pounding) Parkinosn's disease, followed an outpatient or under the DH |
Pazienti di entrambi i sessi, di eta' compresa tra 18 e 65 anni affetti da Sindrome di Gilles de la Tourette, pazienti con comportamento compulsivo (pounding) nella malattia di Parkinosn , seguiti ambulatorialmente o in regime di D.H. |
|
E.4 | Principal exclusion criteria |
Minor, Women of childbearing age.
Hypersensitivity to any component of the product |
Minori
Donne in eta' fertile.
Ipersensibilita' a qualunque componente del prodotto |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The effectiveness of the therapy under study is evaluated by the variation of the scores obtained from the following rating scales administered at baseline and every 3 months: Yale Global Tic Severity Scale (YGTSS) - Yale-Brown Obsessive Compulsive Scale (YBOCS) |
L’efficacia della terapia oggetto di studio verra' valutata tramite la variazione dei punteggi ottenuti dalle seguenti scale di valutazione somministrate al basale e successivamente ogni 3 mesi: Yale Global Tic Severity Scale (YGTSS) - Yale-Brown Obsessive Compulsive Scale (YBOCS) |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
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 | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |