Status:
COMPLETED
Guanfacine for the Treatment of Hyperactivity in Pervasive Developmental Disorder
Lead Sponsor:
Yale University
Collaborating Sponsors:
Emory University
Massachusetts General Hospital
Conditions:
Pervasive Development Disorders
Eligibility:
All Genders
5-14 years
Phase:
PHASE4
Brief 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 chil...
Detailed Description
Pervasive Developmental Disorders (PDDs) are a group of conditions that includes Autistic Disorder, Asperger's disorder and so called Pervasive Developmental Disorder - Not Otherwise Specified. Childr...
Eligibility Criteria
Inclusion
- Diagnosis of PDD (PDD-NOS, Asperger's Disorder, Autistic Disorder)
- Hyperactivity
- Between ages 5 years 0 months and 13 years 11 months.
- Weight \>/= 15 kg (33 lb)
- A mental age of at least 18 months
Exclusion
- Prior failed treatment with an adequate trial of guanfacine in the last 2 years
- Concurrent treatment with another psychoactive medication
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT01238575
Start Date
December 1 2011
End Date
March 1 2014
Last Update
March 31 2020
Active Locations (5)
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1
University of California, Los Angeles
Los Angeles, California, United States, 90024
2
Yale University
New Haven, Connecticut, United States, 06519
3
Emory University
Atlanta, Georgia, United States, 30329
4
Massachusetts General Hospital
Lexington, Massachusetts, United States, 02142