CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 62 enrolled
Drug / intervention
extended-release guanfacine +1 moredrug
Likely dose
extended-release guanfacine 1 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01238575
NCT01238575Phase 4Completed
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Guanfacine for the Treatment of Hyperactivity in Pervasive Developmental Disorder

Yale University·interventional·Posted Nov 10, 2010·Updated Mar 31, 2020

In Brief

A Phase 4 clinical trial evaluating placebo and extended-release guanfacine for Pervasive Development Disorders. Completed, enrolled 62 participants across 5 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPervasive Development Disorders
CountriesUnited States
CollaboratorsEmory University, Massachusetts General Hospital, Seattle Children's Hospital, University of California, Los Angeles, National Institute of Mental Health (NIMH)

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedNov 10, 2010
Enrollment StartDec 1, 2011
Primary CompletionMar 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 15.6 years ago

Interventions

placeboother

Administered for up to 8 weeks.

extended-release guanfacinedrug

1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks