A Folinic Acid Intervention for Autism Spectrum Disorders
|ClinicalTrials.gov Identifier: NCT01602016|
Recruitment Status : Terminated (Non-compliance)
First Posted : May 18, 2012
Results First Posted : November 7, 2016
Last Update Posted : October 17, 2017
|Condition or disease||Intervention/treatment||Phase|
|Autism Spectrum Disorder Autistic Disorder Autism Asperger's Syndrome Pervasive Development Disorders||Drug: Folinic Acid and placebo Drug: Folinic Acid||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||99 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Folinic Acid Intervention for ASD: Links to Folate Receptor-alpha Autoimmunity & Redox Metabolism|
|Study Start Date :||May 2012|
|Actual Primary Completion Date :||November 2015|
|Actual Study Completion Date :||November 2015|
No Intervention: Phase I
Baseline Visit Phase 1: The screening portion of the CELF will be administered to the child to screen for language impairment. If a child is determined to be pre-verbal they will automatically qualify,If there is no language impairment, the subject will not be eligible. If language impairment is confirmed, the participant will immediately go on to the baseline visit of Phase 2.
Phase II: 12 week Folinic Acid or Placebo intervention
The child will be consented for Phase 2 (the RCT) and undergo a blood draw (up to 20mL) for metabolic and autoantibody testing. the child will undergo language and behavioral assessment while the parent will be interviewed for the Vineland and other questionnaires (ASQ, RBS-R, SRS, and ABC). Demographic information including; age, race, gender, and ethnicity will be collected. The research pharmacist will randomize the participant to either Intervention A or B (only the research pharmacist will know which intervention has the folinic acid). The research pharmacist will distribute the drug or placebo to the parent and instruct the parent of the proper administration of the intervention. This will be considered the 12 week randomly controlled clinical trial that is investigating the safety and efficacy of folinic acis interventions in ASD and will last for approximately 12 weeks. At the end of 12 weeks, the same assessments that were conducted at baseline will be readministered
Drug: Folinic Acid and placebo
Capsules of folinic acid and placebo will be administered in 1mg/kg/day in two divided doses (0.5mg/kg/dose; 25mg/day maximum) for two weeks followed by 2 mg/kg/day with a maximum dose of 50mg/day provided the lower dose is well tolerated for 10 weeks.
Experimental: Phase III: Open Label Extension of Folinic Acid
If consent for Phase 3 is signed by parents with children who qualify for Phase 3, the research pharmacist will provide a 12 week supply of folinic acid to the parent. This arm will be offered to all clients that completed phase 2 of the trial. After consenting and 12 weeks of folinic acid dosing, the client will come back and complete the same protocol and be tested on the same measures used in phase II of the study. This will be a rolling stopping point so that new therapies can be started, if the parent/caregiver is so inclined
Drug: Folinic Acid
capsules of folinic acis will be provided. The target dose will be 1mg/kg/day in two divided doses (0.5mg/kg/dose; 25mg/day maximum) for two weeks followed by 2 mg/kg/day with a maximum dose of 50mg/day provided the lower dose is well tolerated, for 10 weeks.
- Language Improvement [ Time Frame: (baseline and 12 weeks ) ]Language (measured by the receptive and expressive CELF language index, and preschool language scale (PLS), as needed) will be the primary outcome for the study. Both preliminary studies have suggested that the folinic acid intervention will be associated with receptive and expressive language improvements.
- Improved Stereotyped Behavior and Improved Social Skills [ Time Frame: (baseline, 6, and 12 weeks) ]Stereotyped behavior (as measured by the OACIS (not at 6 weeks), ASQ, RBS-R, and ABC) and social skills (as measured by the Vineland (not at 6 weeks), ASQ, and SRS) will be the secondary outcomes.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01602016
|United States, Arkansas|
|Arkansas Children's Hospital Research Institute|
|Little Rock, Arkansas, United States, 72205|
|Principal Investigator:||Richard E Frye, M.D./Ph.D.||Director of Autism Research|