CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 20 enrolled
Drug / intervention
Lisdexamfetamine +1 moredrug
Likely dose
Lisdexamfetamine 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/NCT02712996
NCT02712996Phase 4Completed
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Treatment Outcomes With Lisdexamfetamine Dimesylate (Vyvanse) in Children With Traumatic Brain Injury-Related Attention Deficits

Vanderbilt University·interventional·Posted Mar 18, 2016·Updated Jul 13, 2020

In Brief

A Phase 4 clinical trial evaluating Lisdexamfetamine and Placebo for Traumatic Brain Injury and Attention Deficit Disorder. Completed, enrolled 20 participants across 1 site.

Detailed Summary

The purpose of this research study is to evaluate whether Vyvanse, a psychostimulant, can help children ages 6-16 with attention deficits due to traumatic brain injury (TBI). Vyvanse is currently approved for the treatment of Attention-Deficit/Hyperactivity (ADHD). The exact effects this drug may have on adults with attention deficits caused by TBI have been investigated prior. The exact effects this drug may have on children with attention deficits caused by TBI are not known, but the investigators expect that Vyvanse will be of some help in treating this population as well.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTraumatic Brain Injury, Attention Deficit Disorder
CountriesUnited States
CollaboratorsShire

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 18, 2016
Enrollment StartFeb 6, 2017
Primary CompletionJul 1, 2019
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 10.3 years ago

Interventions

Lisdexamfetaminedrug

Lisdexamfetamine (Vyvanse) capsule, 20-70 mg, each morning for 6 weeks.

Placebodrug

Placebo capsule, 20-70 mg, each morning for 6 weeks.