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Treatment of Traumatic Brain Injury (TBI)-Related Attention Deficits in Children

NCT02712996 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2020-07-13

Study results available
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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.

Conditions

Interventions

DRUG

Lisdexamfetamine

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

DRUG

Placebo

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

Sponsors & Collaborators

  • Shire

    collaborator INDUSTRY

  • Vanderbilt University

    lead OTHER

Principal Investigators

  • Michael G Tramontana, Ph.D · Vanderbilt University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
6 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-02-06
Primary Completion
2019-07-01
Completion
2019-07-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02712996 on ClinicalTrials.gov