Autism Spectrum DisorderPhase 2EFFETNCT02551380
Folinic Acid in Children With Autism Spectrum Disorders
A Phase 2 study testing FOLINORAL in people with Autism Spectrum Disorder, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
The investigator planned to study the efficiency of folinic acid treatment on autistic symptoms in children suffering from autism spectrum disorder. Read more about this study
- Who is it for?
- Ages 3 to 10 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- FOLINORAL
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2015to Jan 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
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- Child born premature (<37SA)
- Known intolerance to lactose
- Hypersensitivity / allergic reaction to calcium folinate
- The sibling children with autism spectrum disorders
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Nancy-Hopital Brabois Enfants
Vandœuvre-lès-Nancy, 54511
Bruno LEHEUP, MD, PH.D, +33383154500, b.leheup@chu-nancy.fr
About this study
Official title: 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.
Read the 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
- Conditions
- Autism Spectrum Disorder
- Being tested
- FOLINORAL, Placebo
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FOLINORALDrug
Also called Folinic acid
Folinoral (folinic acid) 5mg twice a day (10 mg per day) during 12 weeks
PlaceboOther
Also called Lactose
Placebo 5mg twice a day (10 mg per day) during 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Treated | Experimental | treatment with Folinoral (folinic acid) 5mg twice a day (10 mg per day) during 12 weeks Receives: Drug: FOLINORAL |
| control | Placebo comparator | treatment with one capsule of placebo twice a day during 12 weeks Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
- Evaluation of the reduction of autistic symptom perceived by parents with a heteroevaluation scale : SRS (social responsiveness scale)
- Comparison of score between folinic acid group and placebo group at T0 (inclusion) and after 12 weeks of treatment
Measured: Change in SRS at 12 weeks
evaluate the constancy of auto antibodies anti-FRα
Serum dosage of auto antibodies anti-FRα at T0 and at 12 weeks to evaluate the constancy of auto antibodies anti-FRα
Measured: change of auto antibodies anti-FRα at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2015 (estimated)
- Study startOct 2015
- Primary completionJan 2018 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bruno Leheup, M.D, Ph.D, Principal investigator, CHU NANCY- Hopital Brabois Enfants
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02551380
- Sponsor's protocol ID
- 2015-000955-25
- Other IDs
- 2015
- Acronym
- EFFET
- Status last verified
- Apr 2017
- First submitted
- 14 Sep 2015
- Last updated
- 7 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: To be completed after discussions with the different research teams participating in the study
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficiency of Folinic Acid in Children With Autism Spectrum Disorders: a Pilot Study "EFFET"
- ClinicalTrials.gov ID
- NCT02551380
- Acronym / sponsor ID
- EFFET / 2015-000955-25
- Conditions
- Autism Spectrum Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 16 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigator planned to study the efficiency of folinic acid treatment on autistic symptoms in children suffering from autism spectrum disorder.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treated | Experimental | Drug: FOLINORALtreatment with Folinoral (folinic acid) 5mg twice a day (10 mg per day) during 12 weeks |
| control | Placebo comparator | Other: Placebotreatment with one capsule of placebo twice a day during 12 weeks |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FOLINORALAlso: Folinic acidFolinoral (folinic acid) 5mg twice a day (10 mg per day) during 12 weeks | Drug | Treated |
| PlaceboAlso: LactosePlacebo 5mg twice a day (10 mg per day) during 12 weeks | Other | control |
Primary outcome
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
2 secondary outcomes
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
evaluate the constancy of auto antibodies anti-FRα
Time frame: change of auto antibodies anti-FRα at 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2017.
- Individual participant dataSharing planned: Undecided. To be completed after discussions with the different research teams participating in the study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruno Leheup, M.D, Ph.D principal investigator
CHU NANCY- Hopital Brabois Enfants
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FOLINORAL in people with Autism Spectrum Disorder, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bruno Leheup, M.D, PH.D (+33 3 83 15 45 00, b.leheup@chu-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of severity of autistic symptoms with standardized scale ADOS (Autism Diagnosis Observation Scale) (time frame: change in ADOS scale at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2017.