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NCT00420459 · ClinicalTrials.gov registry record · Phase 2
A Prospective Open-label Study of Aripiprazole in Fragile X Syndrome
A Phase 2 study, sponsored by Indiana University.
- Completed
- Registry status
- Phase 2
- Development phase
- 12
- Enrollment target
NCT00420459: Completed Phase 2 study, sponsored by Indiana University.
NCT00420459 is a Phase 2 study that has completed, run by Indiana University. The registered enrollment target is 12 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00420459, a Phase 2 study, has completed, sponsored by Indiana University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 12 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the effectiveness and tolerability of aripiprazole in the treatment of children and adolescents with Fragile X Syndrome.
Primary Outcome
The Aberrant Behavior Checklist (ABC) is a 58-item measure of maladaptive behaviors and is used as a measure of drug effects. The ABC has 5 subscales: Social Withdrawal (16 items) ranging from 0 (not at all) to 48 (severe), Irritability (15 items) ranging from 0 (not at all) to 45 (severe), Inappropriate Speech (4 items) ranging from 0 (not at all) to 12 (severe), Hyperactivity (16 items) ranging from 0 (not at all) to 48 (severe), and Stereotypy (7 items) ranging from 0 (not at all) to 21 (seve
Interventions
- DRUG Aripiprazole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2007-04 |
| Est. Completion | 2010-03 |
| Phase | Phase 2 |
What the finished NCT00420459 record still lists
NCT00420459 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 1 intervention - of which Aripiprazole is the first listed.
NCT00420459 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00420459 about?
NCT00420459 is a clinical study titled "A Prospective Open-label Study of Aripiprazole in Fragile X Syndrome". The purpose of this study is to determine the effectiveness and tolerability of aripiprazole in the treatment of children and adolescents with Fragile X Syndrome.
What is the current status of trial NCT00420459?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2007-04. Estimated completion is 2010-03.
What interventions are being tested in trial NCT00420459?
The interventions under investigation include: Aripiprazole (DRUG).
Who is sponsoring clinical trial NCT00420459?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00420459's enrollment target sits among peer trials
12 1948th of 2000 higher than 34 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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