Open-label study on the use of Finasteride in prolonged treatment (4 years) of tics in Tourette's disease and Parkinson's disease in the pounding - FINTOURPARK
- Conditions
- Syndrome Gilles de la Tourette's disease Parkinosn PoundingMedDRA version: 14.1Level: LLTClassification code 10013113Term: Disease Parkinson'sSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2011-000612-26-IT
- Lead Sponsor
- AZIENDA OSPEDALIERO UNIVERSITARIA DI CAGLIARI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
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
Minor, Women of childbearing age.
Hypersensitivity to any component of the product
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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)
- Secondary Outcome Measures
Name Time Method