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NCT01000064 · ClinicalTrials.gov registry record · Phase 3
Treatment of Traumatic Brain Injury (TBI)-Related Attention Deficits
A Phase 3 study, sponsored by Vanderbilt University.
- Terminated
- Registry status
- Phase 3
- Development phase
- 22
- Enrollment target
NCT01000064: Clinical Trial Phase 3 study, sponsored by Vanderbilt University.
NCT01000064 is a Phase 3 study that was terminated before completion, run by Vanderbilt University. The registered enrollment target is 22 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01000064, a Phase 3 study, was terminated before completion, sponsored by Vanderbilt University.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 22 participants
- Enrollment target
Study Summary
The purpose of this research study is to evaluate whether Vyvanse, a psychostimulant, can help 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 attention deficits caused by TBI are not known, but we expect that Vyvanse will be of some help in treating those types of problems as well. The study will utilize functional magnetic resonance imaging (fMRI) methods, as well as neurobehavioral measures, to elucidate neural mechanisms of response.
Primary Outcome
Conner's Continuous Performance Task (CPT-II) measure sustained attention and response inhibition. CPT-II Preservations represent responses in which reaction time was less than 100 ms; these responses are assumed to be anticipatory, random, or slow/inattentive (i.e., carried over from the previous response) because it is physiologically impossible to respond accurately in so short a time. Higher T-scores, percentiles, and means indicate worse performance.
Interventions
- DRUG Placebo
- PROCEDURE fMRI
- DRUG Vyvanse
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2009-10 |
| Est. Completion | 2015-05 |
| Phase | Phase 3 |
Why NCT01000064 stopped before completion
NCT01000064 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01000064 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01000064 about?
NCT01000064 is a clinical study titled "Treatment of Traumatic Brain Injury (TBI)-Related Attention Deficits". The purpose of this research study is to evaluate whether Vyvanse, a psychostimulant, can help 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 attention def...
What is the current status of trial NCT01000064?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 22 participants. The study started on 2009-10. Estimated completion is 2015-05.
What interventions are being tested in trial NCT01000064?
The interventions under investigation include: Placebo (DRUG), fMRI (PROCEDURE), Vyvanse (DRUG).
Who is sponsoring clinical trial NCT01000064?
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 NCT01000064's enrollment target sits among peer trials
22 1953rd of 2000 higher than 48 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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