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Clinical Trial Summary

The investigator planned to study the efficiency of folinic acid treatment on autistic symptoms in children suffering from autism spectrum disorder.


Clinical Trial Description

The aim of this study is to realise a pilot study in France in order to evaluate the efficiency of folinic acid in treatment of autism spectrum disorder and get first estimations about prevalence of auto antibodies anti-FRα in France.

The study is a randomized controlled trial monocentric,evaluating folinic acid 10mg per day versus placebo, in single-blind during 12 weeks.

Primary objective : The primary objective is to evaluate the efficiency of folinic acid (calcium folinate) 5mg twice a day during 12 weeks on reduction of autistic troubles, particularly on communication and social interaction

Secondary objective :

- Evaluate the efficiency of folinic acid on reduction of autistic symptoms perceived by parents

- Evaluate the constancy of auto antibodies anti-FRα rates ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02551380
Study type Interventional
Source Central Hospital, Nancy, France
Contact Bruno Leheup, M.D, PH.D
Phone +33 3 83 15 45 00
Email b.leheup@chu-nancy.fr
Status Recruiting
Phase Phase 2
Start date October 2015
Completion date January 2018

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