Folinic Acid in Children With Autism Spectrum Disorders (EFFET)

Evaluation of the Efficiency of Folinic Acid in Children With Autism Spectrum Disorders: a Pilot Study "EFFET"

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

Study Overview

• Status: Unknown
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Drug: FOLINORAL; Other: Placebo

Detailed 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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Vandoeuvre les Nancy, France, 54511
    • Recruiting
    • CHU Nancy-Hopital Brabois Enfants
    • Contact: Bruno LEHEUP, MD, PH.D; Phone Number: +33383154500; Email: b.leheup@chu-nancy.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Children with autism spectrum disorders defined by : Autism Diagnostic Observation Schedule (ADOS), Autism Diagnostic Interview (ADI), Childhood Autism Rating Scale (CARS) or diagnosed by a physician (pediatrician, child psychiatrist)
2. Children aged 3 to 10 years
3. Weight> 10 kg
4. Language impairment (based on the medical assessment)
5. Ability to maintain other therapies started before the study
6. No changes of therapeutic treatments within the 8 weeks before the start of the study

Exclusion Criteria:

1. Treatment may impair folate metabolism (methotrexate, anticonvulsivants : phenobarbital sodium valproate, phenytoin, primidone, carbamazepine, valproic acid, divalproex, antibiotics : tetracycline, trimethoprim, pyrimethamine, inhibitors of proton pump inhibitors of histamine-2)
2. Antipsychotic treatment (including treatment with Risperidone)
3. Vitamin or mineral supplementation exceeding guidelines
4. Children with severe irritability (Aberrant Behavior Checklist> 17)
5. Gastroesophageal reflux disease
6. Any known renal or liver disease
7. Child born premature (<37SA)
8. Known intolerance to lactose
9. Hypersensitivity / allergic reaction to calcium folinate
10. The sibling children with autism spectrum disorders

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treated; treatment with Folinoral (folinic acid) 5mg twice a day (10 mg per day) during 12 weeks	Drug: FOLINORAL; Folinoral (folinic acid) 5mg twice a day (10 mg per day) during 12 weeks; Other Names: Folinic acid
Placebo Comparator: control; treatment with one capsule of placebo twice a day during 12 weeks	Other: Placebo; Placebo 5mg twice a day (10 mg per day) during 12 weeks; Other Names: Lactose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Investigators: Principal Investigator: Bruno Leheup, M.D, Ph.D, CHU NANCY- Hopital Brabois Enfants

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Anticipated): January 1, 2018
• Study Completion (Anticipated): January 1, 2018

Study Registration Dates

• First Submitted: September 14, 2015
• First Submitted That Met QC Criteria: September 15, 2015
• First Posted (Estimate): September 16, 2015

Study Record Updates

• Last Update Posted (Actual): April 7, 2017
• Last Update Submitted That Met QC Criteria: April 6, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
• Other Study ID Numbers: 2015-000955-25

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: To be completed after discussions with the different research teams participating in the study