CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 42 enrolled
Drug / intervention
Vyvansedrug
Likely dose
Vyvanse 70 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/NCT00733356
NCT00733356Phase 4Completed
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The Effects of Vyvanse(TM) on Brain Hemodynamics and Reading

Kimberley Lakes·interventional·Posted Aug 13, 2008·Updated Feb 14, 2018

In Brief

A Phase 4 clinical trial evaluating Vyvanse for Attention Deficit/Hyperactivity Disorder. Completed, enrolled 42 participants across 1 site.

Detailed Summary

This is a single-blind, Investigator Initiated study to evaluate the safety and efficacy of Vyvanse™ and provide pilot data in two areas: (1) on the use of Near-Infrared Spectroscopy to detect medication effects in children with ADHD; and (2) on the influence of Vyvanse ™ on reading fluency and comprehension, over a period of approximately 6-8 weeks. Subjects will be between the ages of 6 and 12 at the beginning of the study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAttention Deficit/Hyperactivity Disorder
CountriesUnited States
CollaboratorsShire

Timeline

Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 13, 2008
Enrollment StartJul 1, 2008
Primary CompletionSep 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 17.9 years ago

Interventions

Vyvansedrug

Subjects will participate in an open-label dose optimization period and successful titration to an optimal dose of Vyvanse™, subjects will take their optimized dose of Vyvanse™ (30, 50 or 70 mg/day) during the week leading up to their final visit. During the study subjects will take their prescribed dose once a day in the morning with breakfast.