NCT02551380

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 14, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 16, 2015

Completed
15 days until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

April 7, 2017

Status Verified

April 1, 2017

Enrollment Period

2.3 years

First QC Date

September 14, 2015

Last Update Submit

April 6, 2017

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Evaluation of the reduction of autistic symptom perceived by parents with a heteroevaluation scale : SRS (social responsiveness scale)

    Change in SRS at 12 weeks

  • evaluate the constancy of auto antibodies anti-FRα

    change of auto antibodies anti-FRα at 12 weeks

Study Arms (2)

Treated

EXPERIMENTAL

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

Drug: FOLINORAL

control

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

FOLINORALDRUG

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

Also known as: Folinic acid
Treated
PlaceboOTHER

Placebo 5mg twice a day (10 mg per day) during 12 weeks

Also known as: Lactose
control

Eligibility Criteria

Age3 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Nancy-Hopital Brabois Enfants

Vandœuvre-lès-Nancy, 54511, France

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

LeucovorinLactose

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

FormyltetrahydrofolatesTetrahydrofolatesFolic AcidPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsCoenzymesEnzymes and CoenzymesDisaccharidesOligosaccharidesPolysaccharidesCarbohydratesSugars

Study Officials

  • Bruno Leheup, M.D, Ph.D

    CHU NANCY- Hopital Brabois Enfants

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bruno Leheup, M.D, PH.D

CONTACT

+33 3 83 15 45 00b.leheup@chu-nancy.fr

Emeline Renard, resident

CONTACT

+33 6 27 64 71 29e_renard@hotmail.fr

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2015

First Posted

September 16, 2015

Study Start

October 1, 2015

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

April 7, 2017

Record last verified: 2017-04

Locations

FR(1)