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Trial record 1 of 8 for:    autism AND folinic acid
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Folinic Acid in Children With Autism Spectrum Disorders (EFFET)

This study is currently recruiting participants.
See Contacts and Locations
Verified April 2017 by Central Hospital, Nancy, France
Sponsor:
Information provided by (Responsible Party):
Central Hospital, Nancy, France
ClinicalTrials.gov Identifier:
NCT02551380
First received: September 14, 2015
Last updated: April 6, 2017
Last verified: April 2017
  Purpose
The investigator planned to study the efficiency of folinic acid treatment on autistic symptoms in children suffering from autism spectrum disorder.

Condition Intervention Phase
Autism Spectrum Disorder Drug: FOLINORAL Other: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant
Primary Purpose: Treatment
Official Title: Evaluation of the Efficiency of Folinic Acid in Children With Autism Spectrum Disorders: a Pilot Study "EFFET"

Resource links provided by NLM:


Further study details as provided by Central Hospital, Nancy, France:

Primary Outcome Measures:
  • 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:
  • 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


  • 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


Estimated Enrollment: 40
Study Start Date: October 2015
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
  Eligibility

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: September 14, 2015
Last Updated: April 6, 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

ClinicalTrials.gov processed this record on July 26, 2017