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A Folinic Acid Intervention for Autism Spectrum Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01602016
Recruitment Status : Terminated (Non-compliance)
First Posted : May 18, 2012
Results First Posted : November 6, 2016
Last Update Posted : October 17, 2017
Sponsor:
Collaborator:
Arkansas Children's Hospital Research Institute
Information provided by (Responsible Party):
University of Arkansas

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Autism Spectrum Disorder
Autistic Disorder
Autism
Asperger's Syndrome
Pervasive Development Disorders
Interventions Drug: Folinic Acid and placebo
Drug: Folinic Acid
Enrollment 99
Recruitment Details  
Pre-assignment Details The study sponsor (UAMS) was unable to completely monitor the study or resolve outstanding queries. The study data cannot be fully validated by the sponsor. The study was placed on Full Clinical Hold by the FDA and terminated by the sponsor as a result of investigator non-compliance.
Arm/Group Title All Participants
Hide Arm/Group Description [Not Specified]
Period Title: Overall Study
Started 0
Completed 0
Not Completed 0
Arm/Group Title All Participants
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 0
Hide Baseline Analysis Population Description
The study sponsor (UAMS) was unable to completely monitor the study or resolve outstanding queries. The study data cannot be fully validated by the sponsor. The study was placed on Full Clinical Hold by the FDA and terminated by the sponsor as a result of investigator non-compliance.
Age, Continuous  
Number Analyzed 0 participants
Sex: Female, Male  
Number Analyzed 0 participants
Female
Male
1.Primary Outcome
Title Language Improvement
Hide Description 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.
Time Frame (baseline and 12 weeks )
Hide Outcome Measure Data
Hide Analysis Population Description
The study sponsor (UAMS) was unable to completely monitor the study or resolve outstanding queries. The study data cannot be fully validated by the sponsor. The study was placed on Full Clinical Hold by the FDA and terminated by the sponsor as a result of investigator non-compliance.
Arm/Group Title All Participants
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Improved Stereotyped Behavior and Improved Social Skills
Hide Description 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.
Time Frame (baseline, 6, and 12 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
No data because no patients were analyzed.
Arm/Group Title Phase I Phase II: 12 Week Folinic Acid or Placebo Intervention Phase III: Open Label Extension of Folinic Acid
Hide Arm/Group Description:
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.
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

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

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.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description The study sponsor (UAMS) was unable to completely monitor the study or resolve outstanding queries. The study data cannot be fully validated by the sponsor. The study was placed on Full Clinical Hold by the FDA and terminated by the sponsor as a result of investigator non-compliance.
 
Arm/Group Title All Participants
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
All Participants
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
All Participants
Affected / at Risk (%)
Total   0/0 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
All Participants
Affected / at Risk (%)
Total   0/0 
[Not Specified]
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Tracy Gatlin
Organization: University of Arkansas for Medical Sciences
Phone: 501-686-6803
EMail: tlgatlin@uams.edu
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT01602016    
Other Study ID Numbers: 136002
First Submitted: May 15, 2012
First Posted: May 18, 2012
Results First Submitted: November 4, 2016
Results First Posted: November 6, 2016
Last Update Posted: October 17, 2017