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Efficacy and safety of S-adenosil-methionine on depression of patients with Lesch - Nyhan Syndrome - ND

Efficacy and safety of S-adenosil-methionine on depression of patients with Lesch - Nyhan Syndrome - ND

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-004036-23-IT
Enrollment
Unknown
Registered
2010-07-26
Start date
2008-06-23
Completion date
Unknown
Last updated
2012-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depressionin patients affected by Lesch - Nyhan disease MedDRA version: 6.1 Level: HLT Classification code 10052636

Interventions

Trade Name: SAMYR 400 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: SAME Current Sponsor code: SAME Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2

Sponsors

FONDAZIONE MALATTIE RARE MAURO BASCHIROTTO B.I.R.D. ONLUS
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

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

Exclusion criteria: Deglutition impairment Lack of informed consent

Design outcomes

Primary

MeasureTime frame
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—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026