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Folinic acid in young Down syndrome patients
NCT00294593Phase 3
Key facts
- Status
- Completed
- Start
- Oct 2000
- Countries
- 1
- Sponsor
- Institut Jérôme Lejeune
- Modality
- Orthosteric Ligands
- Drugs
- folinic acid
- Conditions
- Down syndrome
01
Overview
Phase 3, randomised, double-blind trial in Down syndrome comparing Folinic acid with Placebo (2 arms). Primary endpoint: Score on a psychomotor development scale (Brunet-Lezine) at 12 months. Started Oct 2000; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Folinic acid
Oral folinic acid 1mg/kg/d
Placebo
Placebo
03
Who it enrols
Inclusion: Down syndrome without mosaicism, age 3 to 30 months, weight over 4 kg. Exclusion: history of leukemia, West syndrome or non-stable epilepsy, non-stable thyroxin treatment.
04
Endpoints
Primary
Score on a psychomotor development scale (Brunet-Lezine)
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