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Folinic Acid in Children With Autism Spectrum Disorders (EFFET)

Primary Purpose

Autism Spectrum Disorder

Status
Unknown status
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
FOLINORAL
Placebo
Sponsored by
Central Hospital, Nancy, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder

Eligibility Criteria

3 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Nancy-Hopital Brabois EnfantsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treated

control

Arm Description

treatment with Folinoral (folinic acid) 5mg twice a day (10 mg per day) during 12 weeks

treatment with one capsule of placebo twice a day during 12 weeks

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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

Full Information

First Posted
September 14, 2015
Last Updated
April 6, 2017
Sponsor
Central Hospital, Nancy, France
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1. Study Identification

Unique Protocol Identification Number
NCT02551380
Brief Title
Folinic Acid in Children With Autism Spectrum Disorders
Acronym
EFFET
Official Title
Evaluation of the Efficiency of Folinic Acid in Children With Autism Spectrum Disorders: a Pilot Study "EFFET"
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 2015 (undefined)
Primary Completion Date
January 2018 (Anticipated)
Study Completion Date
January 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Central Hospital, Nancy, France

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treated
Arm Type
Experimental
Arm Description
treatment with Folinoral (folinic acid) 5mg twice a day (10 mg per day) during 12 weeks
Arm Title
control
Arm Type
Placebo Comparator
Arm Description
treatment with one capsule of placebo twice a day during 12 weeks
Intervention Type
Drug
Intervention Name(s)
FOLINORAL
Other Intervention Name(s)
Folinic acid
Intervention Description
Folinoral (folinic acid) 5mg twice a day (10 mg per day) during 12 weeks
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
Lactose
Intervention Description
Placebo 5mg twice a day (10 mg per day) during 12 weeks
Primary Outcome Measure Information:
Title
Evaluation of severity of autistic symptoms with standardized scale ADOS (Autism Diagnosis Observation Scale)
Description
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
Time Frame
change in ADOS scale at 12 weeks
Secondary Outcome Measure Information:
Title
Evaluation of the reduction of autistic symptom perceived by parents with a heteroevaluation scale : SRS (social responsiveness scale)
Description
- 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
Time Frame
Change in SRS at 12 weeks
Title
evaluate the constancy of auto antibodies anti-FRα
Description
Serum dosage of auto antibodies anti-FRα at T0 and at 12 weeks to evaluate the constancy of auto antibodies anti-FRα
Time Frame
change of auto antibodies anti-FRα at 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Children aged 3 to 10 years Weight> 10 kg Language impairment (based on the medical assessment) Ability to maintain other therapies started before the study No changes of therapeutic treatments within the 8 weeks before the start of the study Exclusion Criteria: 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) Antipsychotic treatment (including treatment with Risperidone) Vitamin or mineral supplementation exceeding guidelines Children with severe irritability (Aberrant Behavior Checklist> 17) Gastroesophageal reflux disease Any known renal or liver disease Child born premature (<37SA) Known intolerance to lactose Hypersensitivity / allergic reaction to calcium folinate The sibling children with autism spectrum disorders
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bruno Leheup, M.D, PH.D
Phone
+33 3 83 15 45 00
Email
b.leheup@chu-nancy.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Emeline Renard, resident
Phone
+33 6 27 64 71 29
Email
e_renard@hotmail.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruno Leheup, M.D, Ph.D
Organizational Affiliation
CHU NANCY- Hopital Brabois Enfants
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Nancy-Hopital Brabois Enfants
City
Vandoeuvre les Nancy
ZIP/Postal Code
54511
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bruno LEHEUP, MD, PH.D
Phone
+33383154500
Email
b.leheup@chu-nancy.fr

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
To be completed after discussions with the different research teams participating in the study

Learn more about this trial

Folinic Acid in Children With Autism Spectrum Disorders

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