A Feasibility Study of N-acetylcysteine for Self-injurious Behavior in Children With Autism Spectrum Disorder

PHASE2CompletedINTERVENTIONAL
Enrollment

8

Participants

Timeline

Start Date

July 5, 2018

Primary Completion Date

September 12, 2019

Study Completion Date

September 12, 2019

Conditions
Autism Spectrum Disorder
Interventions
DRUG

N-acetylcysteine

"Participants will start with taking 900mg of NAC once per day for one week (study days 1-7). At Day 7, parents (or primary caregiver) and subjects will return to the study site to review adverse events.~In the absence of dose limiting adverse events attributable to the study drug, the dose will be gradually increased to 900 mg twice per day for study days 8-28.~If this dose is well-tolerated, the dose will be increased to 900 three times per day for study days 29-63."

DRUG

Placebo

"Participants will start with taking 900mg of the placebo once per day for one week (study days 1-7). At Day 7, parents (or primary caregiver) and subjects will return to the study site to review adverse events. The dosing for the placebo will increase in the same fashion as the active treatment.~In the absence of dose limiting adverse events attributable to the study drug, the dose will be gradually increased to 900 mg twice per day for study days 8-28.~If this dose is well-tolerated, the dose will be increased to 900 three times per day for study days 29-63."

Trial Locations (1)

30329

Marcus Autism Center, Atlanta

All Listed Sponsors
lead

Emory University

OTHER

NCT03008889 - A Feasibility Study of N-acetylcysteine for Self-injurious Behavior in Children With Autism Spectrum Disorder | Biotech Hunter | Biotech Hunter