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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 Pounding
MedDRA version: 14.1Level: LLTClassification code 10013113Term: Disease Parkinson'sSystem Organ Class: 10029205 - Nervous system disorders
Therapeutic 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
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

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
NameTimeMethod
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
NameTimeMethod
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