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Trial record 1 of 10 for:    autism AND folinic acid
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Folinic Acid in Children With Autism Spectrum Disorders (EFFET)

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ClinicalTrials.gov Identifier: NCT02551380
Recruitment Status : Recruiting
First Posted : September 16, 2015
Last Update Posted : April 7, 2017
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Drug: FOLINORAL Other: Placebo Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Evaluation of the Efficiency of Folinic Acid in Children With Autism Spectrum Disorders: a Pilot Study "EFFET"
Study Start Date : October 2015
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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 Name: 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 Name: Lactose


Outcome Measures

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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


  2. 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


Eligibility Criteria

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Ages Eligible for Study:   3 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02551380


Contacts
Contact: Bruno Leheup, M.D, PH.D +33 3 83 15 45 00 b.leheup@chu-nancy.fr
Contact: Emeline Renard, resident +33 6 27 64 71 29 e_renard@hotmail.fr

Locations
France
CHU Nancy-Hopital Brabois Enfants Recruiting
Vandoeuvre les Nancy, France, 54511
Contact: Bruno LEHEUP, MD, PH.D    +33383154500    b.leheup@chu-nancy.fr   
Sponsors and Collaborators
Central Hospital, Nancy, France
Investigators
Principal Investigator: Bruno Leheup, M.D, Ph.D CHU NANCY- Hopital Brabois Enfants
More Information

Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT02551380     History of Changes
Other Study ID Numbers: 2015-000955-25
First Posted: September 16, 2015    Key Record Dates
Last Update Posted: April 7, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: To be completed after discussions with the different research teams participating in the study

Additional relevant MeSH terms:
Autistic Disorder
Autism Spectrum Disorder
Levoleucovorin
Folic Acid
Disease
Child Development Disorders, Pervasive
Pathologic Processes
Neurodevelopmental Disorders
Mental Disorders
Leucovorin
Antidotes
Protective Agents
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Hematinics