Autism spectrum disorders MedDRA version: 18.0 Level: PT Classification code 10063844 Term: Autism spectrum disorder System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Trade Name: FOLINORAL 5mg
Pharmaceutical Form: Capsule
INN or Proposed INN: folinc acid
CAS Number: 6035-45-6
Current Sponsor code: acide folinque
Other descriptive name: CALCIUM FOLINATE PENTAHYDRATE
Sponsors
Centre Hospitalier Régional Universitaire de Nancy
Eligibility
Sex/Gender
All
Inclusion 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 Are the trial subjects under 18? yes Number of subjects for this age range: 40 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1)Treatment may impair folate metabolism (methotrexate, anticonvuslivants : 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of this study is to evaluate the efficiencyof folinic acid, as folinate calicum (FOLINORAL®) 5 mg two times a day during 12 weeks, on the reduction of autism disorder especially on the communication and social interactions.;Secondary Objective: 1)Evaluate the efficiencyof folinic acid on autistic symptoms reducing perceived by parents. 2)Assess the consistency of the anti-receptor antibody levels folate FRa in autistic children 12 weeks after starting treatment. 3)Studying the relationship between the presence of antibodies anti-folate receptor FRa before treatment and the response to folic acid treatment 12 weeks after. 4)Safety evaluation of folinic acid in the 12 weeks of treatment and at the end of this research.;Primary end point(s): Difference of the score obtained by the ADOS scale, for "communication" and "social interaction" items, between baseline visit (T0) and 12 weeks of treatment visit (S12) in the 2 groups (placebo and folinic acid).;Timepoint(s) of evaluation of this end point: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1)Difference of hetero-assessment SRS score (for parents) before treatment (T0) and after 12 weeks of treatment in folinic acid and placebo groups 2)Determination of anti-receptor antibody to folate at baseline and at the end of 12 weeks of treatment in the 2 groups. 3)Response to treatment 12 weeks after initiation 4)Reports of potential side effects at S3 and S6 by phone calls, at S12 durind the visit and at S24 by phone call ;Timepoint(s) of evaluation of this end point: 1)12 weeks 2)12 weeks 3)12 weeks 4)At weeks : 3, 6, 12 and 24 | — |
Countries
France
Contacts
Public ContactSecrétariat
Direction de la Recherche et de l'Innovation
Outcome results
None listed