Treatment of Social and Language Deficits With Leucovorin for Young Children With Autism

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Southwest Autism Research & Resource Center
Study ID
NCT04060030
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
30 Months - 60 Months
Healthy Volunteers
Not accepted

Interventions

  • Levoleucovorin Calcium — DRUG
    Liquid leucovorin calcium dosed by weight
  • Placebo — OTHER
    Placebo

Study Details

The primary objective of this study is to evaluate the cognitive and behavioral effects of liquid leucovorin calcium on young children with autism spectrum disorder (ASD) and determine whether it improves social communication as well as the core and associated symptoms of ASD. The investigators will enroll 80 children across two sites, between the ages of 2.5 and 5 years, with confirmed ASD and known social and communication delays. Participation will last approximately 26 weeks, from screening visit to end of treatment.

Key Dates

Start date
Oct 8, 2020
Status verified
Apr 2026
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: L-leucovorin calcium
    The liquid form of leucovorin calcium will be dosed by weight, with a target dose of 1mg/kg/day, divided into two daily doses. This product may be taken alone or mixed with liquid. Participants randomized to this arm will receive active treatment for both 12-week phases of the study.
  • Placebo Comparator: Placebo
    The placebo will mimic the experimental treatment in flavor, odor, packaging, and dosing instructions. Participants randomized to this arm will receive placebo for the first 12 weeks of the study, then active treatment for the remaining 12 weeks.

Primary Outcome Measure

Evaluate the change in social communication symptoms [ Time Frame: Baseline, Week 6, Week 12, Week 24 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Southwestern Research & Resource CenterPhoenixArizona85016
Christopher Smith, PhD
(602) 218-8192
Sophia Crisler
(480) 582-9467
State University of New York, DownstateBrooklynNew York11203
Harris Huberman, MD
[email protected]
(718) 270-2272
Daniel Mishan
[email protected]
(718) 270-2272

Find similar trials in Phoenix, AZ

By condition
Autism spectrum disorder
By specialty
Pediatrics
By research site
Southwestern Research & Resource Center· Phoenix, AZState University of New York, Downstate· Brooklyn, NY

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