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NCT01172288 · ClinicalTrials.gov registry record · Phase 2
N-acetylcysteine (NAC) for Children With Tourette Syndrome
A Phase 2 study, sponsored by Yale University.
- Completed
- Registry status
- Phase 2
- Development phase
- 31
- Enrollment target
NCT01172288 is a Phase 2 study that has completed, run by Yale University. The registered enrollment target is 31 participants.
The verdict
NCT01172288, a Phase 2 study, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 31 participants
- Enrollment target
Study Summary
Tourette syndrome is a childhood-onset neuropsychiatric disorder characterized by multiple motor and vocal tics that last for at least a year in duration. Currently, there exist several effective pharmacological treatments for childhood tics including alpha-2 agonist medications (guanfacine and clonidine) and neuroleptics (antipsychotic) medications. These medications, however, have significant side-effects and are only partially efficacy in treating tics. N-acetylcysteine (NAC) is a natural supplement that acts as an antioxidant and glutamate modulating agent. NAC has been used safely for decades in doses 20-40 times higher than in this trial as an antidote for acetaminophen overdose. The only side-effect commonly seen with NAC is nausea and this side-effect is seldom seen in the doses used in this trial. NAC has recently been demonstrated to be effective in a double-blind, placebo-controlled trial in adults with trichotillomania (chronic hair pulling). Hairpulling is hypothesized to be closely related to tics because these conditions (1) have similar clinical characteristics -- both groups typically experience urges before engaging in pulling or tics, (2) neuroimaging studies suggest they involve similar brain circuits -- the basal ganglia, (3) the same pharmacological treatments (neuroleptics) may be effective for both conditions and (4) they tend to be inherited together in families. In other trials NAC has evidence of some efficacy in treating diverse psychiatric conditions such as bipolar depression, schizophrenia and cocaine dependence. The investigators are conducting this trial to determine if NAC is an effective treatment for tics.
Interventions
- DRUG Placebo
- DRUG N-Acetylcysteine (NAC)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2010-07 |
| Est. Completion | 2014-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01172288
The ClinicalTrials.gov registry entry for NCT01172288 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Yale University, which has 1,492 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01172288 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01172288 about?
NCT01172288 is a clinical study titled "N-acetylcysteine (NAC) for Children With Tourette Syndrome". Tourette syndrome is a childhood-onset neuropsychiatric disorder characterized by multiple motor and vocal tics that last for at least a year in duration. Currently, there exist several effective pharmacological treatments for childhood tics including alpha-2 agonist medications (guanfacine and clon...
What is the current status of trial NCT01172288?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 31 participants. The study started on 2010-07. Estimated completion is 2014-01.
What interventions are being tested in trial NCT01172288?
The interventions under investigation include: Placebo (DRUG), N-Acetylcysteine (NAC) (DRUG).
Who is sponsoring clinical trial NCT01172288?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
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