Syndrome Gilles de la Tourette's disease Parkinosn Pounding MedDRA version: 14.1 Level: LLT Classification code 10013113 Term: Disease Parkinson's System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: PROSCAR*30CPR RIV 5MG
Pharmaceutical Form: Tablet
INN or Proposed INN: Finasteride
Concentration unit: mg milligram(s)
Concentration number: 5-
Sponsors
AZIENDA OSPEDALIERO UNIVERSITARIA DI CAGLIARI
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Minor, Women of childbearing age. Hypersensitivity to any component of the product
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: demonstrate the clinical efficacy of long-term treatment with finasteride in patients with Tourette's disease \ m Parkinson's;Secondary Objective: 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;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) | — |
Countries
Italy
Outcome results
None listed