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The investigator planned to study the efficiency of folinic acid treatment on autistic symptoms in children suffering from autism spectrum disorder.
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 :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treated | Experimental | treatment with Folinoral (folinic acid) 5mg twice a day (10 mg per day) during 12 weeks |
|
| control | Placebo Comparator | treatment with one capsule of placebo twice a day during 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FOLINORAL | Drug | Folinoral (folinic acid) 5mg twice a day (10 mg per day) during 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of severity of autistic symptoms with standardized scale ADOS (Autism Diagnosis Observation Scale) | Autistic symptoms (particularly communication and social interaction) measured by standardized scale ADOS (Autism Diagnosis Observation Scale) : comparison of score between folinic acid group and placebo at T0 et after 12 weeks of treatment | change in ADOS scale at 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the reduction of autistic symptom perceived by parents with a heteroevaluation scale : SRS (social responsiveness scale) | - Evaluation of the reduction of autistic symptom perceived by parents with a heteroevaluation scale : SRS (social responsiveness scale) o Comparison of score between folinic acid group and placebo group at T0 (inclusion) and after 12 weeks of treatment | Change in SRS at 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bruno Leheup, M.D, PH.D | Contact | +33 3 83 15 45 00 | b.leheup@chu-nancy.fr | |
| Emeline Renard, resident | Contact | +33 6 27 64 71 29 | e_renard@hotmail.fr |
| Name | Affiliation | Role |
|---|---|---|
| Bruno Leheup, M.D, Ph.D | CHU NANCY- Hopital Brabois Enfants | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Nancy-Hopital Brabois Enfants | Recruiting | Vandœuvre-lès-Nancy | 54511 | France |
To be completed after discussions with the different research teams participating in the study
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D002955 | Leucovorin |
| D007785 | Lactose |
| ID | Term |
|---|---|
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
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| Placebo | Other | Placebo 5mg twice a day (10 mg per day) during 12 weeks |
|
|
| evaluate the constancy of auto antibodies anti-FRα | Serum dosage of auto antibodies anti-FRα at T0 and at 12 weeks to evaluate the constancy of auto antibodies anti-FRα | change of auto antibodies anti-FRα at 12 weeks |
| D011621 |
| Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D004187 | Disaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D000073893 | Sugars |