Efficacy and safety of S-adenosil-methionine on depression of patients with Lesch - Nyhan Syndrome - ND
- Conditions
- Depressionin patients affected by Lesch - Nyhan diseaseMedDRA version: 6.1Level: HLTClassification code 10052636
- Registration Number
- EUCTR2007-004036-23-IT
- Lead Sponsor
- FONDAZIONE MALATTIE RARE MAURO BASCHIROTTO B.I.R.D. ONLUS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- Not specified
Inclusion Criteria
Diagnosis of Lesch-Nyhan Disease Neurological symptoms Lesch Nyhan behaviour
More than 18 years of age
Informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
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
Deglutition impairment
Lack of informed consent
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Reduction of depressive symptoms in Lesch - Nyhan syndrome;Secondary Objective: Reduction of neurological and behavioural symptoms Lesch - Nyhan syndrome;Primary end point(s): Mood improvement with reduction of number of Lesch Nyhan behaviours
- Secondary Outcome Measures
Name Time Method