Folinic Acid in Children With Autism Spectrum Disorders (EFFET)

April 6, 2017 updated by: Central Hospital, Nancy, France

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Vandoeuvre les Nancy, France, 54511
        • Recruiting
        • CHU Nancy-Hopital Brabois Enfants
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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)
Time Frame: change in ADOS scale at 12 weeks
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)
Time Frame: Change in SRS at 12 weeks

- 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
Time Frame: change of auto antibodies anti-FRα at 12 weeks
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

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Investigators

  • Principal Investigator: Bruno Leheup, M.D, Ph.D, CHU NANCY- Hopital Brabois Enfants

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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