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NCT01013870 · ClinicalTrials.gov registry record · Phase 2
Mission Connect Mild Traumatic Brain Injury (TBI) Integrated Clinical Protocol
A Phase 2 study, sponsored by Baylor College of Medicine.
- Terminated
- Registry status
- Phase 2
- Development phase
- 52
- Enrollment target
NCT01013870 is a Phase 2 study that was terminated before completion, run by Baylor College of Medicine. The registered enrollment target is 52 participants.
The verdict
NCT01013870, a Phase 2 study, was terminated before completion, sponsored by Baylor College of Medicine.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 52 participants
- Enrollment target
Study Summary
The purpose of this study is to improve the ability to diagnose problems after mild traumatic brain injury (MTBI) and to test a drug that may improve the outcome from these injuries. Of the more than 1.5 million people who experience a traumatic brain injury (TBI) each year in the United States, as many as 75% sustain a mild TBI which can cause long-term or permanent impairments/disabilities in a significant proportion of patients. In addition, traumatic brain injury has become a signature injury of the wars in Iraq and Afghanistan. For people with these injuries, it is difficult to determine whether symptoms are due to the head injury or another condition, such as Post-traumatic Stress Disorder. In this project, there are 3 observational studies that involve testing of mental functions and behavior, imaging of the brain with special x-ray procedures, and blood samples to look at glandular function, which may be affected by head injury. A fourth study is a test of a drug, atorvastatin, which may provide protection for injured brain cells and improve outcome. By collecting and analyzing the information from these tests, it will be possible to make the process of diagnosing mild TBI or post traumatic stress disorder (PTSD) more precise, and also to see if atorvastatin is a helpful drug for patients with MTBI.
Interventions
- DRUG Placebo
- DRUG Atorvastatin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2010-02 |
| Est. Completion | 2015-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01013870
The ClinicalTrials.gov registry entry for NCT01013870 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 52 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baylor College of Medicine, which has 616 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01013870 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01013870 about?
NCT01013870 is a clinical study titled "Mission Connect Mild Traumatic Brain Injury (TBI) Integrated Clinical Protocol". The purpose of this study is to improve the ability to diagnose problems after mild traumatic brain injury (MTBI) and to test a drug that may improve the outcome from these injuries. Of the more than 1.5 million people who experience a traumatic brain injury (TBI) each year in the United States, as ...
What is the current status of trial NCT01013870?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 52 participants. The study started on 2010-02. Estimated completion is 2015-06.
What interventions are being tested in trial NCT01013870?
The interventions under investigation include: Placebo (DRUG), Atorvastatin (DRUG).
Who is sponsoring clinical trial NCT01013870?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
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