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NCT00627705 · ClinicalTrials.gov registry record · Phase 2

A Study of N-Acetyl Cysteine in Children With Autism

A Phase 2 study, sponsored by Stanford University.

Completed
Registry status
Phase 2
Development phase
43
Enrollment target

NCT00627705: Completed Phase 2 study, sponsored by Stanford University.

NCT00627705 is a Phase 2 study that has completed, run by Stanford University. The registered enrollment target is 43 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00627705, a Phase 2 study, has completed, sponsored by Stanford University.

COMPLETED
Registry status
Phase 2
Development phase
43 participants
Enrollment target

Study Summary

The purpose of the study is to test the tolerability and efficacy of N-Acetyl Cysteine (NAC) in children with Autism. NAC is a compound that increases the levels of Glutathione, the body's main antioxidant. Glutathione is a compound in the blood that is part of a natural defense system (the antioxidant system). Anti-oxidants protect the body from damage caused by internal toxins called "free radicals." It is possible that children with Autism tend to have lower levels of glutathione, an important compound in our bodies that helps combat the effects of toxic free radicals. We hope that by studying the antioxidant system in more detail, we will increase our understanding of the reasons why people develop Autism so that we can design better ways to treat individuals with this condition. This study is meant to test the safety tolerability of NAC and its effectiveness in the treatment of behavioral difficulties in children with autism. It will also examine the possible benefit of this agent in improving the core deficits in autism such as social deficits.

Primary Outcome

The Dosage Record and Treatment Emergent Symptom Scale (DOTES) provides information on the presence, frequency, and severity of side effects reported during the course of the trial.

Interventions

  • DRUG N-Acetyl Cysteine
  • OTHER Placebo - sugar pill

Trial Details

FieldValue
Enrollment Target 43 participants
Start Date 2008-02
Est. Completion 2010-09
Phase Phase 2
Stanford University

1,744 total trials

What the finished NCT00627705 record still lists

NCT00627705 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower).

The record links to 0 conditions, and to 2 interventions - of which N-Acetyl Cysteine is the first listed.

NCT00627705 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00627705 about?

NCT00627705 is a clinical study titled "A Study of N-Acetyl Cysteine in Children With Autism". The purpose of the study is to test the tolerability and efficacy of N-Acetyl Cysteine (NAC) in children with Autism. NAC is a compound that increases the levels of Glutathione, the body's main antioxidant. Glutathione is a compound in the blood that is part of a natural defense system (the antioxid...

What is the current status of trial NCT00627705?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 43 participants. The study started on 2008-02. Estimated completion is 2010-09.

What interventions are being tested in trial NCT00627705?

The interventions under investigation include: N-Acetyl Cysteine (DRUG), Placebo - sugar pill (OTHER).

Who is sponsoring clinical trial NCT00627705?

This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00627705's enrollment target sits among peer trials

43 1332nd of 2000 higher than 662 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00627705, the US trial registry maintained by the National Library of Medicine. NCT00627705 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.