Phase 2 Completed N=24 Treatment

An Open-Label Study of N-Acetyl Cysteine in Children With Autism

Autistic Disorder

Source: ClinicalTrials.gov NCT00676195 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2017

Primary outcomePrimary: Number of Participants With Adverse Events Reported on the Dosage Record and Treatment Emergent Symptom Scale (DOTES) — 17 number of participants

Summary

The purpose of the study is to test the tolerability and efficacy of N-Acetyl Cysteine (NAC) in children with Autism.

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Adverse Events Reported on the Dosage Record and Treatment Emergent Symptom Scale (DOTES)	17	—
SECONDARY Social Responsiveness Scale (SRS)	—	—
SECONDARY Sensory Profile Questionnaire (SPQ)	—	—
SECONDARY Irritability Subscale of the Aberrant Behavior Checklist (ABC)	—	—
SECONDARY Glutathione Metabolism Intermediates in Peripheral Blood Measured by High-performance Liquid Chromatography	—	—

Eligibility Criteria

Inclusion Criteria

Subjects will be eligible for this study if they participated in the Double-blind, randomized, placebo controlled study of N-Acetyl Cysteine in Autism study at Stanford University and meet all of the following criteria:

Outpatients between 3.0 and 12.11 years of age inclusive
Males and females who are physically healthy
diagnosis of autism based on Diagnostic and Statistical Manual (DSM-IV-TR) criteria, the Autism Diagnostic Interview-Revised, and expert clinical evaluation
Clinical Global Impression Severity rating of 4
Care provider who can reliably bring subject to clinic visits, can provide trustworthy ratings, and interacts with subject on a regular basis
Ability of subject to swallow the compound
Stable concomitant medications for at least 2 weeks
No planned changes in psychosocial interventions during the open-label N-Acetyl Cysteine trial

Exclusion Criteria

Diagnostic and Statistical Manual (DSM-IV-TR) diagnosis of schizophrenia, schizoaffective disorder, or psychotic disorder, not otherwise specified
Active medical problems: unstable seizures, significant physical illness (e.g., serious liver or renal pathology)
Pregnancy or sexually active females
Subjects taking antioxidant agents and glutathione prodrugs will be excluded from the study except if they have been off these compounds for at least 4 weeks

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00676195). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.