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Mission Connect Mild Traumatic Brain Injury (TBI) Integrated Clinical Protocol

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ClinicalTrials.gov Identifier: NCT01013870
Recruitment Status : Terminated (inability to recruit adequate numbers of subjects)
First Posted : November 16, 2009
Results First Posted : November 17, 2016
Last Update Posted : January 9, 2017
Sponsor:
Collaborator:
The University of Texas Health Science Center, Houston
Information provided by (Responsible Party):
Claudia Sue Robertson, Baylor College of Medicine

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Traumatic Brain Injury
Post-traumatic Stress Disorder
Interventions Drug: Atorvastatin
Drug: Placebo
Enrollment 52
Recruitment Details  
Pre-assignment Details  
Arm/Group Title mTBI-atorvastatin Group mTBI-placebo Group
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 28 24
Completed 27 21
Not Completed 1 3
Reason Not Completed
Lost to Follow-up             1             3
Arm/Group Title mTBI-atorvastatin Group mTBI-placebo Group Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 28 24 52
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 28 participants 24 participants 52 participants
29.1  (9.0) 29.9  (9.9) 29.5  (9.3)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 24 participants 52 participants
Female
10
  35.7%
7
  29.2%
17
  32.7%
Male
18
  64.3%
17
  70.8%
35
  67.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 24 participants 52 participants
Hispanic or Latino
8
  28.6%
10
  41.7%
18
  34.6%
Not Hispanic or Latino
20
  71.4%
14
  58.3%
34
  65.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 24 participants 52 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
11
  39.3%
7
  29.2%
18
  34.6%
White
17
  60.7%
16
  66.7%
33
  63.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
1
   4.2%
1
   1.9%
Primary Language  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 28 participants 24 participants 52 participants
English 27 21 48
Spanish 1 3 4
Education  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 28 participants 24 participants 52 participants
1-8 years 1 1 2
some high school 1 4 5
high school graduate 8 8 16
some college 12 6 18
college graduate 4 3 7
post-graduate 0 1 1
vocational 2 0 2
unknown 0 1 1
Galveston Orientation and Amnesia Test Score   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 28 participants 24 participants 52 participants
=100 23 23 46
<100 5 1 6
[1]
Measure Description: The GOAT assesses the duration of post-traumatic amnesia and was assessed on presentation to the hospital. It includes 10 items on recovery of orientation to person, place, and time and the maximum score is 100. (Levin, H., O'Donnell, V., and Grossman, R. [1979]. The Galveston Orientation and Amnesia Test. A practical scale to assess cognition after head injury. J Nerv Ment Dis 167[11], 675-684.). Categories used were normal (=100) or some abnormality (<100).
Glasgow Coma Scale Score   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 28 participants 24 participants 52 participants
15 27 23 50
14 1 1 2
[1]
Measure Description: GCS was obtained in the emergency room on presentation as an assessment of neurological status. The score has 3 components: eye opening (1-4), verbal response (1-5), and motor response (1-6). The components are summed for a score that ranges from 3-15. Normal GCS is 15, less than 15 indicates some abnormality.
Head Abbreviated Injury Score   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 28 participants 24 participants 52 participants
1 16 16 32
2 12 8 20
[1]
Measure Description: The head component of the Abbreviated Injury Score describes the severity of a head injury. The score ranges from 1-6, with a higher score indicating a more severe injury. Patients were excluded from this study if any component AIS was greater than 2.
Injury Severity Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 28 participants 24 participants 52 participants
3.6  (2.0) 3.5  (1.9) 3.6  (1.9)
[1]
Measure Description: ISS is a score that describes the overall injury severity and was determined at presentation to the hospital. There are 9 body regions where the injury severity is assessed on a scale from 1-6, with a higher score indicating a more severe injury. Is all body region scores are < 6, then the ISS is calculated by summing the square of the 3 highest region scores. If any of the body region scores is 6 (unsurvivable) then the ISS is set to 75. The ISS score ranges from 1-75.
1.Primary Outcome
Title Rivermead Post-Concussion Symptoms Questionnaire, at 3 Months After Injury.
Hide Description 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.)
Time Frame 3 months after injury
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title mTBI-atorvastatin Group mTBI-placebo Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 27 22
Median (Full Range)
Unit of Measure: units on a scale
2
(0 to 49)
3.5
(0 to 54)
2.Secondary Outcome
Title Medical Outcome Study Short Form 12 - Mental Score
Hide Description 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.)
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title mTBI-atorvastatin Group mTBI-placebo Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 27 22
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
52
(42.75 to 57)
52
(42.5 to 57.5)
3.Secondary Outcome
Title Medical Outcome Study Short Form 12 - Physical Score
Hide Description 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.)
Time Frame 3 months after injury
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title mTBI-atorvastatin Group mTBI-placebo Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 27 22
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
55
(51.25 to 57.75)
56.5
(52 to 58)
4.Secondary Outcome
Title Post-traumatic Stress Checklist - Civilian Form
Hide Description 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.)
Time Frame 3 months after injury
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title mTBI-atorvastatin Group mTBI-placebo Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 27 22
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
24
(18 to 29.5)
21
(19 to 27.25)
5.Secondary Outcome
Title Connor Davidson Resilience Measure
Hide Description 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].
Time Frame 3 months after injury
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title mTBI-atorvastatin Group mTBI-placebo Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 27 22
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
84
(72.25 to 95)
84
(73.5 to 93)
6.Secondary Outcome
Title Center for Epidemiological Study Depression Scale
Hide Description 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.)
Time Frame 3 months after injury
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title mTBI-atorvastatin Group mTBI-placebo Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 27 22
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
6
(1.25 to 17.0)
5.5
(3.5 to 11.5)
7.Secondary Outcome
Title Brief Visuospatial Memory Test - Revised
Hide Description 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.
Time Frame 3 months after injury
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title mTBI-atorvastatin Group mTBI-placebo Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 27 22
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
33
(21.25 to 43.5)
31
(23.3 to 37)
8.Secondary Outcome
Title Symbol Digit Modalities Test - Oral Score
Hide Description 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.
Time Frame 3 months after injury
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title mTBI-atorvastatin Group mTBI-placebo Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 27 22
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
60
(52 to 70.5)
68
(53 to 76)
9.Secondary Outcome
Title Symbol Digit Modalities Test - Written Score
Hide Description 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.
Time Frame 3 months after injury
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title mTBI-atorvastatin Group mTBI-placebo Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 27 22
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
55
(47.25 to 63)
55
(45.5 to 66)
Time Frame Three months after injury
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title mTBI-atorvastatin Group mTBI-placebo Group
Hide Arm/Group Description 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. 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.
All-Cause Mortality
mTBI-atorvastatin Group mTBI-placebo Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
mTBI-atorvastatin Group mTBI-placebo Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/28 (0.00%)   0/24 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
mTBI-atorvastatin Group mTBI-placebo Group
Affected / at Risk (%) Affected / at Risk (%)
Total   11/28 (39.29%)   10/24 (41.67%) 
Gastrointestinal disorders     
constipation   4/28 (14.29%)  3/24 (12.50%) 
abdominal pain   1/28 (3.57%)  2/24 (8.33%) 
flatulence   7/28 (25.00%)  6/24 (25.00%) 
diarrhea   3/28 (10.71%)  2/24 (8.33%) 
General disorders     
fatigue   3/28 (10.71%)  4/24 (16.67%) 
fever   0/28 (0.00%)  1/24 (4.17%) 
not feeling well   0/28 (0.00%)  1/24 (4.17%) 
Renal and urinary disorders     
change in urine   2/28 (7.14%)  1/24 (4.17%) 
Skin and subcutaneous tissue disorders     
itching   1/28 (3.57%)  1/24 (4.17%) 
rash   1/28 (3.57%)  0/24 (0.00%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Claudia Robertson, MD
Organization: Baylor College of Medicine
Phone: 713-873-2792
EMail: claudiar@bcm.edu
Publications:
Ware JE Jr., Kosinski M, Turner-Bowker DM, 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
Weathers F, Litz B, Herman D, Huska J, Keane T. 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., October 1993
Radloff LS. The CES-D Scale: A self-report depression scale for research in the general population. App Psychol Meas. 1977;1:385-401.
Layout table for additonal information
Responsible Party: Claudia Sue Robertson, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT01013870     History of Changes
Other Study ID Numbers: W81XWH-08-2-0132
First Submitted: November 13, 2009
First Posted: November 16, 2009
Results First Submitted: August 3, 2016
Results First Posted: November 17, 2016
Last Update Posted: January 9, 2017