Folinic Acid in Autism

NCT03771560 | Completed Phase 2 Results FDA Drug

• 1 other identifier: Folinic acid
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

An examination of changes in urinary metabolites with use of folinic acid in children with autism spectrum disorder (ASD). Investigators will also measure behavioral measures and academic measures monthly at school with teachers and parents report.

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (2)

• Aberrant Behavior Checklist (ABC) - Parent Reported Change

  The Aberrant Behavior Checklist - parent reported version measures aberrant behavior in children and young adults. There are 58 questions.The scoring of one question can range from 0 (not a problem) to 3 (severe) points on a Likert scale. The total possible score range for the ABC is 0 - 174. Analysis will be performed for mean of total score change over time. Scoring from 0-3 Not a problem = 0, Slightly = 1, Moderately Serious =2, Severe =3 Lower score indicates better performance.

  Baseline to Week 12

• Aberrant Behavior Checklist (ABC) - Teacher Reported Change

  The Aberrant Behavior Checklist - teacher reported version measures aberrant behavior in children and young adults. There are 58 questions. The scoring of ABC questions can range from 0 (not a problem) to 3 (severe) points on a likert scale. The total possible score range for the ABC is 0 - 174. Analysis will be performed for mean of total score change over time. Scoring from 0-3 Not a problem = 0, Slightly = 1, Moderately Serious =2, Severe =3 Lower score indicates better performance.

  Baseline to Week 12

Secondary Outcomes (3)

• Social Responsiveness Scale (SRS) - Parent Reported Change

  Baseline to Week 12

• Social Responsiveness Scale (SRS) - Teacher Reported Change

  Baseline to Week 12

• Pediatric Quality of Life (PedsQL) - Parent Reported Change

  Baseline to Week 12

Study Arms (1)

Open-label

EXPERIMENTAL

In this open-label trial, all subjects will receive the twice daily dose of folinic acid. Folinic acid will be delivered in pill form at a weight-based dose.

Drug: folinic acid

Interventions

folinic acid DRUG

subject will take folinic acid daily for 12 weeks

Also known as: leucovorin calcium

Open-label

Eligibility Criteria

• Age: 5 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Between ages 5 and 25

You may not qualify if:

• Not currently taking folinic acid

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Leucovorin

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes

Results Point of Contact

• Title: Dr. Robert Hendren
• Organization: UCSF

STAR@ucsf.edu

415-502-3500

Study Officials

• Robert Hendren, DO

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: February 14, 2018
• First Posted: December 11, 2018
• Study Start: February 15, 2018
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2018
• Last Updated: December 3, 2019
• Results First Posted: December 3, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)