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NCT01238575 · ClinicalTrials.gov registry record · Phase 4
Guanfacine for the Treatment of Hyperactivity in Pervasive Developmental Disorder
A Phase 4 study of Pervasive Development Disorders, sponsored by Yale University.
- Completed
- Registry status
- Phase 4
- Development phase
- 62
- Enrollment target
- 5
- Study locations
NCT01238575: Completed Phase 4 study of Pervasive Development Disorders, sponsored by Yale University.
NCT01238575 is a Phase 4 study of Pervasive Development Disorders that has completed, run by Yale University. The registered enrollment target is 62 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01238575, a Phase 4 study of Pervasive Development Disorders, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 62 participants
- Enrollment target
- 5
- Study locations
Study Summary
The purpose of this study is to determine whether guanfacine (trade name Intuniv) by itself or in combination with methylphenidate (also known as Ritalin) is helpful for treating hyperactivity in children and adolescents with a Pervasive Developmental Disorders (PDDs).
Primary Outcome
The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. The full ABC is a 58-item parent-rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. The 16-item Hyperactivity subscale covers over-activity (7 items), impulsiveness (2 items), inattention (3 items) and noncompliance (4 items). It has been used as a primary outcome measure in several trials of
Conditions Studied
Interventions
- OTHER placebo
- DRUG extended-release guanfacine
Study Locations (5)
California
- University of California, Los Angeles - Los Angeles
Connecticut
- Yale University - New Haven
Georgia
- Emory University - Atlanta
Massachusetts
- Massachusetts General Hospital - Lexington
Washington
- Seattle Children's Hospital - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2011-12 |
| Est. Completion | 2014-03 |
| Phase | Phase 4 |
What the finished NCT01238575 record still lists
NCT01238575 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower).
The record links to 1 condition, with Pervasive Development Disorders appearing as the primary indexed condition, and to 2 interventions - of which placebo is the first listed.
NCT01238575 lists 5 locations in 5 states (California, Connecticut, Georgia).
Frequently Asked Questions
What is clinical trial NCT01238575 about?
NCT01238575 is a clinical study titled "Guanfacine for the Treatment of Hyperactivity in Pervasive Developmental Disorder". The purpose of this study is to determine whether guanfacine (trade name Intuniv) by itself or in combination with methylphenidate (also known as Ritalin) is helpful for treating hyperactivity in children and adolescents with a Pervasive Developmental Disorders (PDDs).
What is the current status of trial NCT01238575?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 62 participants. The study started on 2011-12. Estimated completion is 2014-03.
What conditions does trial NCT01238575 study?
This clinical trial studies the following conditions: Pervasive Development Disorders.
What interventions are being tested in trial NCT01238575?
The interventions under investigation include: placebo (OTHER), extended-release guanfacine (DRUG).
Who is sponsoring clinical trial NCT01238575?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01238575 being conducted?
This trial has 5 study locations across California, Connecticut, Georgia, Massachusetts, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01238575's enrollment target sits among peer trials
62 1110th of 2000 higher than 882 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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