A Folinic Acid Intervention for Autism Spectrum Disorders

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Autism Spectrum Disorder, Autistic Disorder, Autism, Asperger's Syndrome, Pervasive Development Disorders

In brief

Researchers at Arkansas Children's Hospital Research Institute are conducting a study looking at the effects of Folinic Acid on language in Autism Spectrum Disorder and language impairment. The study has 3 phases. Phase 1 confirms that your child has language impairment (there is no compensation for this visit). If language impairment is verified in the phase 1 screening, then your child will be eligible for phase 2. Phase 2 consists of receiving 12 weeks of folinic acid or an inactive placebo, in addition to several evaluations of your child's abilities and a single blood test. Children that complete phase 2 will be eligible for a 12 week open-label trial of folinic acid which is phase 3.

Key facts

Study ID

NCT01602016

Run by

University of Arkansas

People needed

99

Starts

2012-05-01

Expected to finish

2015-11-01

Last updated by the study team

2017-10-17

Who can join

Age: 3 and older, up to 14. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 1. Autism Spectrum Disorder (as defined by a gold standard measure for ASD diagnosis: the Autism Diagnostic Observation Schedule and/or Autism Diagnostic Interview-Revised). In an event where sufficient diagnostic information is lacking, and the PI believes that the clients meet all other inclusion criteria and a prospective diagnosis of an ASD is clinically warranted, and a formal diagnosis is scheduled to occur within a reasonable time frame from the date of study entry but before dispersing study drug/placebo, then the client may be considered as potentially eligible. Furthermore, a research-reliable rater must complete the diagnosis.
• 2. 3 years to 14 years of age
• 3. Language Impairment
• 4. Ability to maintain complementary, traditional, and/or behavioral interventions and to attempt to keep them constant during the study, when possible.
• 5. Unchanged complementary, traditional, and/or behavioral intervention for approximately 8 weeks prior to study entry, when possible.

You may not qualify if…

• 1. Currently taking Antipsychotic medication
• 2. Vitamin or Element Supplementation that exceeds the IOM Tolerable Upper Intake Levels
• 3. Any moderate to severe positive response on that Aberrant Behavior Checklist Irritability subscale on questions: Injures self on purpose, is aggressive to other children or adults (verbally or physically), deliberately hurts himself/herself, and/or does physical violence to self.
• 4. Prematurity (<34 weeks gestation) as determined by medical history
• 5. Current uncontrolled gastroesophageal reflux or ongoing significant kidney or liver disease. The PI will determine whether any ongoing kidney or liver disease is significant.
• Drugs known to affect folate metabolism (e.g., methotrexate) and their derivatives.
• Profound sensory deficits (e.g. hearing and vision deficits) that could interfere with the interpretation of study results.
• Any major genetic defect, or mutation, that is known to be associated with disease or possibly related to disease that affects folate, methylation, and/or glutathione metabolism. Questions regarding eligibility concerning this criterion will be addressed with the lead site PI before enrollment into the trial.
• Documented current or active seizures, as defined by a clinical seizure or abnormal EEG within the past 6 months.
• Children with major single-gene abnormalities, such as Fragile X, Rett's Syndrome, etc., recognized chromosome syndromes, such as 15q11 microdeletion syndrome, or have been diagnosed with other well recognized syndromes, such as fetal alcohol syndrome. Children with copy number variants that represent known polymorphisms or benign changes will not be excluded. Questions regarding eligibility concerning this criterion should be addressed with the lead site PI before enrollment into the trial.
• Children diagnosed with congenital brain malformations, acquired brain insults, congenital or acquired microcephaly, or infection of the central nervous system.
• Children with major well-defined metabolic disease, such as mitochondrial disease, urea cycle disorders, succinic semialdehyde dehydrogenase deficiency, creatine deficiency syndromes, etc.
• Current therapies that could potentially interfere with interpretation of study results.
• Other conditions which, in the opinion of the study team, will place subjects at unacceptable risk or result in inability to interpret the study data.
• Unwillingness or inability to return for follow-up testing at specified interval.

Where it is running

• Arkansas Children's Hospital Research Institute — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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