EUCTR2017-000687-16-IT
Active, Not Recruiting
Phase 1
ovel avenues for the rescue of intellectual disability in Down syndrome - Novel avenues for the rescue of intellectual disability in Down
AOU FEDERICO II0 sites20 target enrollmentJune 8, 2021
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- DOWN SYNDROME
- Sponsor
- AOU FEDERICO II
- Enrollment
- 20
- Status
- Active, Not Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Subjects of either gender with Down syndrome aged between 5 and 10, extremes included;
- •\- Subjects who gave their consent to participate to the study by informed consent signature from parents or legal tutors before any data collection;
- •\- Subjects in euthyroidism (reference value: FT4\) with or without drug therapy;
- •\- Subjects, celiac or not, with negative values at screening for celiac disease (reference value: Antitransglutaminase antibodies IgA);
- •\- Subjects who never took fluoxetine previously.
- •\- Patients not treated with contraindicated concomitant therapies
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) no
- •F.1\.2\.1 Number of subjects for this age range
Exclusion Criteria
- •\- Subjects aged less than 5 or more than 10;
- •\- Subjects with concomitant neurological diseases other than those expected for the Down syndrome phenotype;
- •\- Subjects with neuropsychiatric diseases: Depressive and Bipolar Disorders;
- •\- Subjects with major malformations requiring prolonged hospitalization;
- •\- Subjects with concomitant medical conditions such as: epilepsy, thyroid dysfunction (not in euthyroidism), diabetes, gastrointestinal,
- •hepatic or renal problems that may alter the absorption and the metabolism of the experimental drug; patients with bleeding disorders or history of bleeding disorders;
- •\- Subjects with long QT syndrome and/or familiarity of long QT syndrome;
- •\- Subjects with congenital cardiopathy, nocturnal apnea syndrome, pericarditis and myocarditis, hypertension or hypertensive crisis,
- •blood electrolytes alterations (in particular, potassium and calcium);
- •\- Subjects treated with controindicated concomitant therapies:
Outcomes
Primary Outcomes
Not specified
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