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NCT04381897 · ClinicalTrials.gov registry record · Phase 2
Use of N-Acetylcysteine in the Treatment of Repetitive and Self-Injurious Behaviors in Cornelia de Lange Syndrome
A Phase 2 study, sponsored by Johns Hopkins University.
- Not yet
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
NCT04381897: Clinical Trial Phase 2 study, sponsored by Johns Hopkins University.
NCT04381897 is a Phase 2 study that has not yet begun recruiting, run by Johns Hopkins University. The registered enrollment target is 10 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04381897, a Phase 2 study, has not yet begun recruiting, sponsored by Johns Hopkins University.
- NOT YET RECRUITING
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
Study Summary
This research project is a randomized cross-over pilot trial which aims to test the efficacy of N-acetylcysteine (NAC) for the treatment of Repetitive Behaviors (RB) and self-injurious behavior (SIB) in patients with Cornelia de Lange Syndrome (CdLs). NAC is a known anti-oxidative stress and neuroprotective agent, which has been shown to decrease the occurrence of SIB such as skin picking. NAC has also shown partial response in trials for compulsive behaviors in Obsessive Compulsive Disorder (OCD) and related disorders in autism. Cornelia de Lange syndrome (CdLS) is a genetic disorder with autistic features, including RBs and SIB. In this randomized clinical trial, participants with CdLS will be blindly assigned one of two possible treatment arms: 1) placebo (8 weeks) and NAC (8 weeks); or 2) NAC (8 weeks) and placebo (8 weeks), with an intermediate 2-week washout period.
Interventions
- OTHER Placebo
- DRUG N-acetyl cysteine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2026-08-01 |
| Est. Completion | 2027-05-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04381897
The ClinicalTrials.gov registry entry for NCT04381897 describes a study currently listed as not yet recruiting, categorized as Phase 2. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04381897 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04381897 about?
NCT04381897 is a clinical study titled "Use of N-Acetylcysteine in the Treatment of Repetitive and Self-Injurious Behaviors in Cornelia de Lange Syndrome". This research project is a randomized cross-over pilot trial which aims to test the efficacy of N-acetylcysteine (NAC) for the treatment of Repetitive Behaviors (RB) and self-injurious behavior (SIB) in patients with Cornelia de Lange Syndrome (CdLs). NAC is a known anti-oxidative stress and neurop...
What is the current status of trial NCT04381897?
This trial is currently not yet recruiting. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2026-08-01. Estimated completion is 2027-05-01.
What interventions are being tested in trial NCT04381897?
The interventions under investigation include: Placebo (OTHER), N-acetyl cysteine (DRUG).
Who is sponsoring clinical trial NCT04381897?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
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