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NCT02712996 · ClinicalTrials.gov registry record · Phase 4
Treatment of Traumatic Brain Injury (TBI)-Related Attention Deficits in Children
A Phase 4 study, sponsored by Vanderbilt University.
- Completed
- Registry status
- Phase 4
- Development phase
- 20
- Enrollment target
NCT02712996: Completed Phase 4 study, sponsored by Vanderbilt University.
NCT02712996 is a Phase 4 study that has completed, run by Vanderbilt University. The registered enrollment target is 20 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02712996, a Phase 4 study, has completed, sponsored by Vanderbilt University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 20 participants
- Enrollment target
Study 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.
Primary Outcome
The Conners-3 Parent Form is used to obtain the parent's observations about behavior in their child aged 6 to 18 years old. Parents rate the child's behavior on 45 items as not true at all (0) to very much true (3). The lowest scale score is 0 (better behavior) and the highest is 135 (worse behavior). The Conners 3-P includes content Scales of Inattention, Hyperactivity/Impulsivity, Learning Problems, Executive Functioning, Aggression, and Peer/Family Relations. Inattention scale was reported as
Interventions
- DRUG Placebo
- DRUG Lisdexamfetamine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2017-02-06 |
| Est. Completion | 2019-07-01 |
| Phase | Phase 4 |
What the finished NCT02712996 record still lists
NCT02712996 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02712996 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02712996 about?
NCT02712996 is a clinical study titled "Treatment of Traumatic Brain Injury (TBI)-Related Attention Deficits in Children". 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 ha...
What is the current status of trial NCT02712996?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 20 participants. The study started on 2017-02-06. Estimated completion is 2019-07-01.
What interventions are being tested in trial NCT02712996?
The interventions under investigation include: Placebo (DRUG), Lisdexamfetamine (DRUG).
Who is sponsoring clinical trial NCT02712996?
This trial is sponsored by Vanderbilt University, which has 430 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02712996's enrollment target sits among peer trials
20 1753rd of 2000 higher than 167 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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