Trial Outcomes & Findings for Mission Connect Mild Traumatic Brain Injury (TBI) Integrated Clinical Protocol (NCT NCT01013870)
NCT ID: NCT01013870
Last Updated: 2017-01-09
Results Overview
The Rivermead Post-Concussive Symptoms Questionnaire (RPQ) is a 16-item self-report measure of the presence and severity of the 16 most commonly reported post-concussive symptoms found in the literature. The scale compares any current symptoms to pre-injury symptom levels to account for potential symptom exacerbation due to TBI. The range of scores is 0-64. Values for each of the 16 items include 0 (not experienced at all), 1 (no more of a problem than before the injury), 2 (mild problem), 3 (moderate problem), 4 (severe problem). The total score was a summation of symptoms that represented new symptom onset or an exacerbation of a symptom present pre-injury. (King, N.S., Crawford, S., Wenden, F.J., Moss, N.E., \& Wade, D.T. \[1995\]. The Rivermead Post Concussion Symptoms Questionnaire: A Measure of Symptoms Commonly Experiences after Head Injury and its Reliability. Journal of Neurology 242: 587-92.)
TERMINATED
PHASE2
52 participants
3 months after injury
2017-01-09
Participant Flow
Participant milestones
| Measure |
mTBI-atorvastatin Group
1:1 randomization will be used to assign half of enrolled subjects to the treatment arm. These subjects will receive a daily weight-based dose of atorvastatin 1mg/kg (up to 80 mg) for 7 days starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving a placebo.
|
mTBI-placebo Group
1:1 randomization will be used to assign half of enrolled subjects to the placebo arm. These subjects will receive a daily dose of an inert preparation, visually indistinguishable from the active agent. They will take this preparation for 7 days, starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving atorvastatin.
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
24
|
|
Overall Study
COMPLETED
|
27
|
21
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
| Measure |
mTBI-atorvastatin Group
1:1 randomization will be used to assign half of enrolled subjects to the treatment arm. These subjects will receive a daily weight-based dose of atorvastatin 1mg/kg (up to 80 mg) for 7 days starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving a placebo.
|
mTBI-placebo Group
1:1 randomization will be used to assign half of enrolled subjects to the placebo arm. These subjects will receive a daily dose of an inert preparation, visually indistinguishable from the active agent. They will take this preparation for 7 days, starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving atorvastatin.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
3
|
Baseline Characteristics
Mission Connect Mild Traumatic Brain Injury (TBI) Integrated Clinical Protocol
Baseline characteristics by cohort
| Measure |
mTBI-atorvastatin Group
n=28 Participants
1:1 randomization will be used to assign half of enrolled subjects to the treatment arm. These subjects will receive a daily weight-based dose of atorvastatin 1mg/kg (up to 80 mg) for 7 days starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving a placebo.
|
mTBI-placebo Group
n=24 Participants
1:1 randomization will be used to assign half of enrolled subjects to the placebo arm. These subjects will receive a daily dose of an inert preparation, visually indistinguishable from the active agent. They will take this preparation for 7 days, starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving atorvastatin.
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29.1 years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
29.9 years
STANDARD_DEVIATION 9.9 • n=7 Participants
|
29.5 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
|
Gender
Female
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Gender
Male
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Primary Language
English
|
27 participants
n=5 Participants
|
21 participants
n=7 Participants
|
48 participants
n=5 Participants
|
|
Primary Language
Spanish
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Education
1-8 years
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Education
some high school
|
1 participants
n=5 Participants
|
4 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Education
high school graduate
|
8 participants
n=5 Participants
|
8 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Education
some college
|
12 participants
n=5 Participants
|
6 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Education
college graduate
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Education
post-graduate
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Education
vocational
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Education
unknown
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Galveston Orientation and Amnesia Test Score
=100
|
23 participants
n=5 Participants
|
23 participants
n=7 Participants
|
46 participants
n=5 Participants
|
|
Galveston Orientation and Amnesia Test Score
<100
|
5 participants
n=5 Participants
|
1 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Glasgow Coma Scale Score
15
|
27 participants
n=5 Participants
|
23 participants
n=7 Participants
|
50 participants
n=5 Participants
|
|
Glasgow Coma Scale Score
14
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Head Abbreviated Injury Score
1
|
16 participants
n=5 Participants
|
16 participants
n=7 Participants
|
32 participants
n=5 Participants
|
|
Head Abbreviated Injury Score
2
|
12 participants
n=5 Participants
|
8 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Injury Severity Score
|
3.6 units on a scale
STANDARD_DEVIATION 2.0 • n=5 Participants
|
3.5 units on a scale
STANDARD_DEVIATION 1.9 • n=7 Participants
|
3.6 units on a scale
STANDARD_DEVIATION 1.9 • n=5 Participants
|
PRIMARY outcome
Timeframe: 3 months after injuryPopulation: The analysis population includes all 27 patients in the atorvastatin group who completed the study and the 21 placebo group patients who completed the study plus one lost to follow-up at 6 months but had completed all of the outcome assessments for the primary and secondary outcomes at 3 months (for a total of 22 placebo group patients).
The Rivermead Post-Concussive Symptoms Questionnaire (RPQ) is a 16-item self-report measure of the presence and severity of the 16 most commonly reported post-concussive symptoms found in the literature. The scale compares any current symptoms to pre-injury symptom levels to account for potential symptom exacerbation due to TBI. The range of scores is 0-64. Values for each of the 16 items include 0 (not experienced at all), 1 (no more of a problem than before the injury), 2 (mild problem), 3 (moderate problem), 4 (severe problem). The total score was a summation of symptoms that represented new symptom onset or an exacerbation of a symptom present pre-injury. (King, N.S., Crawford, S., Wenden, F.J., Moss, N.E., \& Wade, D.T. \[1995\]. The Rivermead Post Concussion Symptoms Questionnaire: A Measure of Symptoms Commonly Experiences after Head Injury and its Reliability. Journal of Neurology 242: 587-92.)
Outcome measures
| Measure |
mTBI-atorvastatin Group
n=27 Participants
1:1 randomization will be used to assign half of enrolled subjects to the treatment arm. These subjects will receive a daily weight-based dose of atorvastatin 1mg/kg (up to 80 mg) for 7 days starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving a placebo.
|
mTBI-placebo Group
n=22 Participants
1:1 randomization will be used to assign half of enrolled subjects to the placebo arm. These subjects will receive a daily dose of an inert preparation, visually indistinguishable from the active agent. They will take this preparation for 7 days, starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving atorvastatin.
|
|---|---|---|
|
Rivermead Post-Concussion Symptoms Questionnaire, at 3 Months After Injury.
|
2 units on a scale
Interval 0.0 to 49.0
|
3.5 units on a scale
Interval 0.0 to 54.0
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: The analysis population includes all 27 patients in the atorvastatin group who completed the study and the 21 placebo group patients who completed the study plus one lost to follow-up at 6 months but had completed all of the outcome assessments for the primary and secondary outcomes at 3 months (for a total of 22 placebo group patients).
SF-12 is a self-report questionnaire that assesses functional health and well-being. There are 12 items in 8 subscales, including physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Physical and Mental Health Composite Scores are computed using the scores of the 12 questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. Both Physical and Mental Health Composite Scales combine the 12 items in such a way that they compare to a national norm with a mean score of 50.0 and a standard deviation of 10.0. (Ware, J.E., Jr., Kosinski, M., Turner-Bowker, D.M., Gandek, B. How to Score Version 2 of the SF-12v2® Health Survey \[With a Supplement Documenting SF-12® Health Survey\] Lincoln, RI: QualityMetric Incorporated, 2002.)
Outcome measures
| Measure |
mTBI-atorvastatin Group
n=27 Participants
1:1 randomization will be used to assign half of enrolled subjects to the treatment arm. These subjects will receive a daily weight-based dose of atorvastatin 1mg/kg (up to 80 mg) for 7 days starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving a placebo.
|
mTBI-placebo Group
n=22 Participants
1:1 randomization will be used to assign half of enrolled subjects to the placebo arm. These subjects will receive a daily dose of an inert preparation, visually indistinguishable from the active agent. They will take this preparation for 7 days, starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving atorvastatin.
|
|---|---|---|
|
Medical Outcome Study Short Form 12 - Mental Score
|
52 units on a scale
Interval 42.75 to 57.0
|
52 units on a scale
Interval 42.5 to 57.5
|
SECONDARY outcome
Timeframe: 3 months after injuryPopulation: The analysis population includes all 27 patients in the atorvastatin group who completed the study and the 21 placebo group patients who completed the study plus one lost to follow-up at 6 months but had completed all of the outcome assessments for the primary and secondary outcomes at 3 months (for a total of 22 placebo group patients).
SF-12 is a self-report questionnaire that assesses functional health and well-being. There are 12 items in 8 subscales, including physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Physical and Mental Health Composite Scores are computed using the scores of the 12 questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. Both Physical and Mental Health Composite Scales combine the 12 items in such a way that they compare to a national norm with a mean score of 50.0 and a standard deviation of 10.0. (Ware, J.E., Jr., Kosinski, M., Turner-Bowker, D.M., Gandek, B. How to Score Version 2 of the SF-12v2® Health Survey \[With a Supplement Documenting SF-12® Health Survey\] Lincoln, RI: QualityMetric Incorporated, 2002.)
Outcome measures
| Measure |
mTBI-atorvastatin Group
n=27 Participants
1:1 randomization will be used to assign half of enrolled subjects to the treatment arm. These subjects will receive a daily weight-based dose of atorvastatin 1mg/kg (up to 80 mg) for 7 days starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving a placebo.
|
mTBI-placebo Group
n=22 Participants
1:1 randomization will be used to assign half of enrolled subjects to the placebo arm. These subjects will receive a daily dose of an inert preparation, visually indistinguishable from the active agent. They will take this preparation for 7 days, starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving atorvastatin.
|
|---|---|---|
|
Medical Outcome Study Short Form 12 - Physical Score
|
55 units on a scale
Interval 51.25 to 57.75
|
56.5 units on a scale
Interval 52.0 to 58.0
|
SECONDARY outcome
Timeframe: 3 months after injuryPopulation: The analysis population includes all 27 patients in the atorvastatin group who completed the study and the 21 placebo group patients who completed the study plus one lost to follow-up at 6 months but had completed all of the outcome assessments for the primary and secondary outcomes at 3 months (for a total of 22 placebo group patients).
The Post Traumatic Stress Disorder Checklist (PCL) is a 17-item self report measure of the DSM-IV symptoms of PTSD. Respondents rate how much they were "bothered by a symptom" on a 5-point scale ranging from 1 ("not at all") to 5 ("extremely"). The PCL was scored as a total score (range 17-85), with higher total scores indicating more symptoms. (Weathers, F., Litz, B., Herman, D., Huska, J., \& Keane, T. \[October 1993\]. The PTSD Checklist \[PCL\]: Reliability, Validity, and Diagnostic Utility. Paper presented at the Annual Convention of the International Society for Traumatic Stress Studies, San Antonio, TX.)
Outcome measures
| Measure |
mTBI-atorvastatin Group
n=27 Participants
1:1 randomization will be used to assign half of enrolled subjects to the treatment arm. These subjects will receive a daily weight-based dose of atorvastatin 1mg/kg (up to 80 mg) for 7 days starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving a placebo.
|
mTBI-placebo Group
n=22 Participants
1:1 randomization will be used to assign half of enrolled subjects to the placebo arm. These subjects will receive a daily dose of an inert preparation, visually indistinguishable from the active agent. They will take this preparation for 7 days, starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving atorvastatin.
|
|---|---|---|
|
Post-traumatic Stress Checklist - Civilian Form
|
24 units on a scale
Interval 18.0 to 29.5
|
21 units on a scale
Interval 19.0 to 27.25
|
SECONDARY outcome
Timeframe: 3 months after injuryPopulation: The analysis population includes all 27 patients in the atorvastatin group who completed the study and the 21 placebo group patients who completed the study plus one lost to follow-up at 6 months but had completed all of the outcome assessments for the primary and secondary outcomes at 3 months (for a total of 22 placebo group patients).
The Connor-Davidson Resilience scale (CD-RISC) has 25 items, each rated on a 5-point scale (0-4), with higher scores reflecting greater resilience. The sum score has a range from 0 to 100. (Conner KM, Davidson JR. Development of a new resilience scale: the Connor-Davidson Resilience Scale \[CD-RISC\]. Depress Anxiety 18\[2\]:76-82,2003\].
Outcome measures
| Measure |
mTBI-atorvastatin Group
n=27 Participants
1:1 randomization will be used to assign half of enrolled subjects to the treatment arm. These subjects will receive a daily weight-based dose of atorvastatin 1mg/kg (up to 80 mg) for 7 days starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving a placebo.
|
mTBI-placebo Group
n=22 Participants
1:1 randomization will be used to assign half of enrolled subjects to the placebo arm. These subjects will receive a daily dose of an inert preparation, visually indistinguishable from the active agent. They will take this preparation for 7 days, starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving atorvastatin.
|
|---|---|---|
|
Connor Davidson Resilience Measure
|
84 units on a scale
Interval 72.25 to 95.0
|
84 units on a scale
Interval 73.5 to 93.0
|
SECONDARY outcome
Timeframe: 3 months after injuryPopulation: The analysis population includes all 27 patients in the atorvastatin group who completed the study and the 21 placebo group patients who completed the study plus one lost to follow-up at 6 months but had completed all of the outcome assessments for the primary and secondary outcomes at 3 months (for a total of 22 placebo group patients).
The CES-D is a widely used screening scale for depression, assessing depressive feelings and behaviors occurring in the past week of a patient's life. The CES-D consists of 20 items, which make up six scales reflecting depressive symptomatology: depressed mood, feelings of guilt and worthlessness, feelings of helplessness and hopelessness, psychomotor retardation, loss of appetite, and sleep disturbance. Each item is scored on a 4-point scale ranging from 0 (rarely/none of the time) to 3 (most/all of the time). Scores for items 4, 8, 12, and 16 are reversed before summing all items to yield a total score, which can range from 0-60. Higher scores indicate more depressive symptoms. (Radloff, LS \[1977\]. The CES-D Scale: A self-report depression scale for research in the general population. App Psychol Meas, 1, 385-401.)
Outcome measures
| Measure |
mTBI-atorvastatin Group
n=27 Participants
1:1 randomization will be used to assign half of enrolled subjects to the treatment arm. These subjects will receive a daily weight-based dose of atorvastatin 1mg/kg (up to 80 mg) for 7 days starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving a placebo.
|
mTBI-placebo Group
n=22 Participants
1:1 randomization will be used to assign half of enrolled subjects to the placebo arm. These subjects will receive a daily dose of an inert preparation, visually indistinguishable from the active agent. They will take this preparation for 7 days, starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving atorvastatin.
|
|---|---|---|
|
Center for Epidemiological Study Depression Scale
|
6 units on a scale
Interval 1.25 to 17.0
|
5.5 units on a scale
Interval 3.5 to 11.5
|
SECONDARY outcome
Timeframe: 3 months after injuryPopulation: The analysis population includes all 27 patients in the atorvastatin group who completed the study and the 21 placebo group patients who completed the study plus one lost to follow-up at 6 months but had completed all of the outcome assessments for the primary and secondary outcomes at 3 months (for a total of 22 placebo group patients).
The BVMT-R is a measure of visuospatial memory. Six equivalent, alternate stimulus forms consist of six geometric figures printed in a 2 x 3 array on separate pages. In three Learning Trials, the subject views the stimulus page for 10 seconds and is asked to draw as many of the figures as possible in their correct location. A Delayed Recall Trial is administered after a 25-minute delay. Last, a Recognition Trial, in which the respondent is asked to identify which of 12 figures were included among the original geometric figures, is administered. Scoring of the immediate and delayed recall are based on the accuracy of the drawings and the location of the figures. For each figure, one point is awarded to each satisfactory domain resulting in a maximum of 12-points per trial.
Outcome measures
| Measure |
mTBI-atorvastatin Group
n=27 Participants
1:1 randomization will be used to assign half of enrolled subjects to the treatment arm. These subjects will receive a daily weight-based dose of atorvastatin 1mg/kg (up to 80 mg) for 7 days starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving a placebo.
|
mTBI-placebo Group
n=22 Participants
1:1 randomization will be used to assign half of enrolled subjects to the placebo arm. These subjects will receive a daily dose of an inert preparation, visually indistinguishable from the active agent. They will take this preparation for 7 days, starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving atorvastatin.
|
|---|---|---|
|
Brief Visuospatial Memory Test - Revised
|
33 units on a scale
Interval 21.25 to 43.5
|
31 units on a scale
Interval 23.3 to 37.0
|
SECONDARY outcome
Timeframe: 3 months after injuryPopulation: The analysis population includes all 27 patients in the atorvastatin group who completed the study and the 21 placebo group patients who completed the study plus one lost to follow-up at 6 months but had completed all of the outcome assessments for the primary and secondary outcomes at 3 months (for a total of 22 placebo group patients).
The SDMT is a measure of divided attention, visual scanning and motor speed. This measure involves a coding key consisting of 9 abstract symbols, each paired with a number ranging from 1 to 9. The subject is required to scan the key and write down the number corresponding to each symbol as fast as possible. The number of correct substitution within 90 seconds is recorded. In the written version of the test the subject fills in the numbers that correspond to the symbols. In the oral version the examiner records the numbers spoken by the subject. The score is the number of correctly coded items from 0-110 in 90 seconds. A higher score indicates better performance.
Outcome measures
| Measure |
mTBI-atorvastatin Group
n=27 Participants
1:1 randomization will be used to assign half of enrolled subjects to the treatment arm. These subjects will receive a daily weight-based dose of atorvastatin 1mg/kg (up to 80 mg) for 7 days starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving a placebo.
|
mTBI-placebo Group
n=22 Participants
1:1 randomization will be used to assign half of enrolled subjects to the placebo arm. These subjects will receive a daily dose of an inert preparation, visually indistinguishable from the active agent. They will take this preparation for 7 days, starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving atorvastatin.
|
|---|---|---|
|
Symbol Digit Modalities Test - Oral Score
|
60 units on a scale
Interval 52.0 to 70.5
|
68 units on a scale
Interval 53.0 to 76.0
|
SECONDARY outcome
Timeframe: 3 months after injuryPopulation: The analysis population includes all 27 patients in the atorvastatin group who completed the study and the 21 placebo group patients who completed the study plus one lost to follow-up at 6 months but had completed all of the outcome assessments for the primary and secondary outcomes at 3 months (for a total of 22 placebo group patients).
The SDMT is a measure of divided attention, visual scanning and motor speed. This measure involves a coding key consisting of 9 abstract symbols, each paired with a number ranging from 1 to 9. The subject is required to scan the key and write down the number corresponding to each symbol as fast as possible. The number of correct substitution within 90 seconds is recorded. In the written version of the test the subject fills in the numbers that correspond to the symbols. In the oral version the examiner records the numbers spoken by the subject. The score is the number of correctly coded items from 0-110 in 90 seconds. A higher score indicates better performance.
Outcome measures
| Measure |
mTBI-atorvastatin Group
n=27 Participants
1:1 randomization will be used to assign half of enrolled subjects to the treatment arm. These subjects will receive a daily weight-based dose of atorvastatin 1mg/kg (up to 80 mg) for 7 days starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving a placebo.
|
mTBI-placebo Group
n=22 Participants
1:1 randomization will be used to assign half of enrolled subjects to the placebo arm. These subjects will receive a daily dose of an inert preparation, visually indistinguishable from the active agent. They will take this preparation for 7 days, starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving atorvastatin.
|
|---|---|---|
|
Symbol Digit Modalities Test - Written Score
|
55 units on a scale
Interval 47.25 to 63.0
|
55 units on a scale
Interval 45.5 to 66.0
|
Adverse Events
mTBI-atorvastatin Group
mTBI-placebo Group
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
mTBI-atorvastatin Group
n=28 participants at risk
1:1 randomization will be used to assign half of enrolled subjects to the treatment arm. These subjects will receive a daily weight-based dose of atorvastatin 1mg/kg (up to 80 mg) for 7 days starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving a placebo.
|
mTBI-placebo Group
n=24 participants at risk
1:1 randomization will be used to assign half of enrolled subjects to the placebo arm. These subjects will receive a daily dose of an inert preparation, visually indistinguishable from the active agent. They will take this preparation for 7 days, starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving atorvastatin.
|
|---|---|---|
|
Gastrointestinal disorders
constipation
|
14.3%
4/28 • Three months after injury
|
12.5%
3/24 • Three months after injury
|
|
Gastrointestinal disorders
abdominal pain
|
3.6%
1/28 • Three months after injury
|
8.3%
2/24 • Three months after injury
|
|
General disorders
fatigue
|
10.7%
3/28 • Three months after injury
|
16.7%
4/24 • Three months after injury
|
|
General disorders
fever
|
0.00%
0/28 • Three months after injury
|
4.2%
1/24 • Three months after injury
|
|
Gastrointestinal disorders
flatulence
|
25.0%
7/28 • Three months after injury
|
25.0%
6/24 • Three months after injury
|
|
Skin and subcutaneous tissue disorders
itching
|
3.6%
1/28 • Three months after injury
|
4.2%
1/24 • Three months after injury
|
|
Gastrointestinal disorders
diarrhea
|
10.7%
3/28 • Three months after injury
|
8.3%
2/24 • Three months after injury
|
|
Renal and urinary disorders
change in urine
|
7.1%
2/28 • Three months after injury
|
4.2%
1/24 • Three months after injury
|
|
General disorders
not feeling well
|
0.00%
0/28 • Three months after injury
|
4.2%
1/24 • Three months after injury
|
|
Skin and subcutaneous tissue disorders
rash
|
3.6%
1/28 • Three months after injury
|
0.00%
0/24 • Three months after injury
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place