Efficacy assessment of systematic treatment with folinic acid and thyroid hormone on psychomotor development of Down Syndrome young children - ACTHYF

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-021134-66-FR

Enrollment

256

Registered

2011-07-04

Start date

Unknown

Completion date

Unknown

Last updated

2020-11-30

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

Conditions

Down syndrome MedDRA version: 14.0 Level: PT Classification code 10044688 Term: Trisomy 21 System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 14.0 Level: LLT Classification code 10013616 Term: Down's syndrome System Organ Class: 10010331 - Congenital, familial and genetic disorders

Interventions

Trade Name: Levothyrox sodique 25 Pharmaceutical Form: Tablet INN or Proposed INN: LEVOTHYROXINE SODIUM CAS Number: 55-03-8 Concentration unit: µg microgram(s) Concentration type: equal Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patient with a caryotype of a homogenous trisomy 21, free or with or robertsonian translocation, - Patient with echocardiography showing no evidence of cardiopathy or valular leak, - Patient aged 6 to 18 months at inclusion, Are the trial subjects under 18? yes Number of subjects for this age range: 256 F.1.2 Adults (18-64 years) no 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: - patient with current or past hypothyroidy - patient with current or past TSH> 5mUI/l, - leucémoid reaction at birth - past or present leukemia, West Syndrome, seizure or any other neurological instable disorder, - past or present signs of CNS damage : stroke, hypoxia, meningitis, - past or present severe cardiac disease or significant valvular leak at echocardiography, - uncontrolled cardiac rythm abnormalities, - Apgar < 7 at 5 mn of birth, - gestationnal age < 245 jours (35 semaines),

Design outcomes

Primary

Measure	Time frame
Main Objective: Psychomotor development efficacy assessment of two medications on Down's syndrome young children : - systematic thyroxin treatment with clinically and biologically controlled dosing, - systematic folinic acid treatment, - interaction assessment between the two medications;Secondary Objective: Identify genetic and biochemical items influencing treatment outcome;Primary end point(s): GQ of GMDS (Griffiths);Timepoint(s) of evaluation of this end point: 0, 6, 12 months	—

Measure

Time frame

Main Objective: Psychomotor development efficacy assessment of two medications on Down's syndrome young children : - systematic thyroxin treatment with clinically and biologically controlled dosing, - systematic folinic acid treatment, - interaction assessment between the two medications;Secondary Objective: Identify genetic and biochemical items influencing treatment outcome;Primary end point(s): GQ of GMDS (Griffiths);Timepoint(s) of evaluation of this end point: 0, 6, 12 months

—

Secondary

Measure	Time frame
Secondary end point(s): Brunet Lézine scale;Timepoint(s) of evaluation of this end point: 0, 6, 12 months	—

Countries

France

Outcome results

None listed

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