Trial Outcomes & Findings for Neuroactive Steroids and Traumatic Brain Injury (TBI) in OEF/OIF Veterans (NCT NCT01336413)
NCT ID: NCT01336413
Last Updated: 2019-07-12
Results Overview
The CAPS-IV criterion D is defined by persistent symptoms of increasing arousal (not present before the trauma), indicated by at least two of the following: difficulty falling or staying asleep, irritability or outbursts of anger, difficulty concentrating, hyper-vigilance, and exaggerated startle response There are two scales, frequency and intensity. Frequency scores range from 0 = "none of the time" to 4 = "most or all of the time" and intensity scores range from 0 = "none" to 4 = "extreme." Severity scores are calculated from the sum of frequency and intensity scores. Five items are included in criterion D, thus the range of severity scores is 0-45. Higher scores are indicative of more symptoms.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
53 participants
Primary outcome timeframe
Baseline, 4 Weeks, and 8 Weeks
Results posted on
2019-07-12
Participant Flow
Participant milestones
| Measure |
Pregnenolone
Pregnenolone: Pregnenolone 50 mg BID x 14 DAYS, followed by Pregnenolone 150 mg BID x 14 DAYS, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial
|
Placebo
Placebo: Same as active comparator, except placebo dispensed.
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
26
|
|
Overall Study
COMPLETED
|
26
|
18
|
|
Overall Study
NOT COMPLETED
|
1
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Neuroactive Steroids and Traumatic Brain Injury (TBI) in OEF/OIF Veterans
Baseline characteristics by cohort
| Measure |
Pregnenolone
n=27 Participants
Pregnenolone: Pregnenolone 50 mg BID x 14 DAYS, followed by Pregnenolone 150 mg BID x 14 DAYS, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial
|
Placebo
n=26 Participants
Placebo: Same as active comparator, except placebo dispensed.
|
Total
n=53 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32.74 years
STANDARD_DEVIATION 5.40 • n=5 Participants
|
35.04 years
STANDARD_DEVIATION 6.75 • n=7 Participants
|
33.87 years
STANDARD_DEVIATION 6.15 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
51 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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 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
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=5 Participants
|
26 participants
n=7 Participants
|
53 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 4 Weeks, and 8 WeeksPopulation: 3 subjects in Arm 1, and 1 subject in Arm 2, withdrew prior to the final visit of the study
The CAPS-IV criterion D is defined by persistent symptoms of increasing arousal (not present before the trauma), indicated by at least two of the following: difficulty falling or staying asleep, irritability or outbursts of anger, difficulty concentrating, hyper-vigilance, and exaggerated startle response There are two scales, frequency and intensity. Frequency scores range from 0 = "none of the time" to 4 = "most or all of the time" and intensity scores range from 0 = "none" to 4 = "extreme." Severity scores are calculated from the sum of frequency and intensity scores. Five items are included in criterion D, thus the range of severity scores is 0-45. Higher scores are indicative of more symptoms.
Outcome measures
| Measure |
Pregnenolone
n=26 Participants
Pregnenolone: Pregnenolone 50 mg BID x 14 DAYS, followed by Pregnenolone 150 mg BID x 14 DAYS, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial
|
Placebo
n=18 Participants
Placebo: Same as active comparator, except placebo dispensed.
|
|---|---|---|
|
CAPS (Cluster D Symptoms) - PRIMARY BEHAVIORAL OUTCOME MEASURE
Baseline
|
13.88 Score
Standard Error 1.51
|
12.89 Score
Standard Error 2.07
|
|
CAPS (Cluster D Symptoms) - PRIMARY BEHAVIORAL OUTCOME MEASURE
4 Weeks
|
11.23 Score
Standard Error 1.63
|
10.89 Score
Standard Error 2.33
|
|
CAPS (Cluster D Symptoms) - PRIMARY BEHAVIORAL OUTCOME MEASURE
8 Weeks
|
9.13 Score
Standard Error 1.46
|
12.24 Score
Standard Error 2.32
|
PRIMARY outcome
Timeframe: Baseline, 4 Weeks, and 8 WeeksPopulation: 3 subjects in Arm 1, and 1 subject in Arm 2, withdrew prior to the final visit of the study.
Subscale test asking subjects to determine the minimum number of moves that will be required to make convert one image of colored balls on pegs into a second different image. The test administers 20 items/images, with 2 additional items if all of the first 20 are answered correctly. Thus, scores range from 0-22, with lower scores representing greater impairment. Raw scores are converted to z scores that generally range from -3 to 3, with lower scores again representing greater impairment.
Outcome measures
| Measure |
Pregnenolone
n=26 Participants
Pregnenolone: Pregnenolone 50 mg BID x 14 DAYS, followed by Pregnenolone 150 mg BID x 14 DAYS, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial
|
Placebo
n=18 Participants
Placebo: Same as active comparator, except placebo dispensed.
|
|---|---|---|
|
Tower of London (Subscale Test of BAC) - PRIMARY COGNITIVE OUTCOME MEASURE
Baseline
|
0.23 z Score
Standard Error 0.14
|
-0.17 z Score
Standard Error 0.24
|
|
Tower of London (Subscale Test of BAC) - PRIMARY COGNITIVE OUTCOME MEASURE
4 Weeks
|
0.36 z Score
Standard Error 0.15
|
0.14 z Score
Standard Error 0.22
|
|
Tower of London (Subscale Test of BAC) - PRIMARY COGNITIVE OUTCOME MEASURE
8 Weeks
|
0.20 z Score
Standard Error 0.17
|
0.43 z Score
Standard Error 0.21
|
SECONDARY outcome
Timeframe: Baseline, 4 Weeks, and 8 WeeksPopulation: 3 subjects in Arm 1, and 1 subject in Arm 2, withdrew prior to the final visit of the study.
21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression. Scores range from 0 (no depression) to 63 (severe depression).
Outcome measures
| Measure |
Pregnenolone
n=26 Participants
Pregnenolone: Pregnenolone 50 mg BID x 14 DAYS, followed by Pregnenolone 150 mg BID x 14 DAYS, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial
|
Placebo
n=18 Participants
Placebo: Same as active comparator, except placebo dispensed.
|
|---|---|---|
|
Beck Depression Inventory-II (BDI-II)
Baseline
|
11.27 Total Score
Standard Error 1.15
|
10.56 Total Score
Standard Error 2.30
|
|
Beck Depression Inventory-II (BDI-II)
4 Weeks
|
8.42 Total Score
Standard Error 1.24
|
8.44 Total Score
Standard Error 1.89
|
|
Beck Depression Inventory-II (BDI-II)
8 Weeks
|
7.30 Total Score
Standard Error 0.87
|
8.88 Total Score
Standard Error 2.05
|
SECONDARY outcome
Timeframe: Baseline, 4 Weeks, and 8 WeeksPopulation: 3 subjects in Arm 1, and 1 subject in Arm 2, withdrew prior to the final visit of the study.
Composite z scores (allowing comparison from week 2 to week 10) to assess cognitive changes. The BAC includes brief assessments of executive functions, verbal fluency, attention, verbal memory, working memory and motor speed. z scores are calculated from composite scores. Higher z scores are indicative of better cognitive performance, lower z scores are indicative of lower cognitive performance. Range of z scores anticipated to be between -3 and 3.
Outcome measures
| Measure |
Pregnenolone
n=26 Participants
Pregnenolone: Pregnenolone 50 mg BID x 14 DAYS, followed by Pregnenolone 150 mg BID x 14 DAYS, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial
|
Placebo
n=18 Participants
Placebo: Same as active comparator, except placebo dispensed.
|
|---|---|---|
|
BAC Composite
Baseline
|
-0.14 Composite z Score
Standard Error 0.22
|
-0.59 Composite z Score
Standard Error 0.26
|
|
BAC Composite
4 Weeks
|
0.26 Composite z Score
Standard Error 0.20
|
-0.10 Composite z Score
Standard Error 0.29
|
|
BAC Composite
8 Weeks
|
0.18 Composite z Score
Standard Error 0.26
|
0.17 Composite z Score
Standard Error 0.28
|
SECONDARY outcome
Timeframe: Baseline, 4 Weeks, and 8 WeeksPopulation: 3 subjects in Arm 1, and 1 subject in Arm 2, withdrew prior to the final visit of the study.
Mean scores in posttraumatic stress disorder symptoms. Scores may range from 0 (no symptoms) to 136 (severe symptoms; score of 136 is based on the first 17 CAPS items administered). A reduced CAPS score indicates a reduction in (improvement) PTSD symptoms, while and increase in CAPS score indicates an increase (worsening) in PTSD symptoms.
Outcome measures
| Measure |
Pregnenolone
n=26 Participants
Pregnenolone: Pregnenolone 50 mg BID x 14 DAYS, followed by Pregnenolone 150 mg BID x 14 DAYS, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial
|
Placebo
n=18 Participants
Placebo: Same as active comparator, except placebo dispensed.
|
|---|---|---|
|
CAPS Total Scores
Baseline
|
32.04 Total Score
Standard Error 4.02
|
33.33 Total Score
Standard Error 5.72
|
|
CAPS Total Scores
4 Weeks
|
23.65 Total Score
Standard Error 3.52
|
26.22 Total Score
Standard Error 6.24
|
|
CAPS Total Scores
8 Weeks
|
22.83 Total Score
Standard Error 4.04
|
27.47 Total Score
Standard Error 6.52
|
SECONDARY outcome
Timeframe: Baseline, 4 Weeks, and 8 WeeksPopulation: 3 subjects in Arm 1, and 1 subject in Arm 2, withdrew prior to the final visit of the study.
The CD-RISC was developed and tested as (i) a measure of degree of resilience, (ii) as a predictor of outcome to treatment with medication or psychotherapy, stress management and resilience-building, (iii) as a marker of progress during treatment, and (iv) as a marker of biological changes in the brain. The scale comprises 25 items, each rated on a 5-point scale (0-4) for a total range of 0-100, with higher scores reflecting greater resilience.
Outcome measures
| Measure |
Pregnenolone
n=26 Participants
Pregnenolone: Pregnenolone 50 mg BID x 14 DAYS, followed by Pregnenolone 150 mg BID x 14 DAYS, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial
|
Placebo
n=18 Participants
Placebo: Same as active comparator, except placebo dispensed.
|
|---|---|---|
|
Connor-Davidson Resilience Scale (CD-RISC)
Baseline
|
70.19 Total Score
Standard Error 2.38
|
69.06 Total Score
Standard Error 4.42
|
|
Connor-Davidson Resilience Scale (CD-RISC)
4 Weeks
|
71.73 Total Score
Standard Error 2.45
|
72.22 Total Score
Standard Error 3.87
|
|
Connor-Davidson Resilience Scale (CD-RISC)
8 Weeks
|
72.13 Total Score
Standard Error 2.62
|
73.11 Total Score
Standard Error 4.00
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 10 weeksFunctional Magnetic Resonance Imaging (fMRI) to assess possible functional brain changes related to attention and emotion circuits associated with the intervention. The dependent measure is the BOLD (fMRI) response to images of faces expressing neutral emotions and fearful emotions.
Outcome measures
| Measure |
Pregnenolone
n=11 Participants
Pregnenolone: Pregnenolone 50 mg BID x 14 DAYS, followed by Pregnenolone 150 mg BID x 14 DAYS, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial
|
Placebo
n=6 Participants
Placebo: Same as active comparator, except placebo dispensed.
|
|---|---|---|
|
Functional Magnetic Resonance Imaging (Exploratory Neuroimaging Outcome)
pre-treatment neutral condition
|
-3.598 BOLD percent signal change in vmPFC
Standard Error 1.978
|
5.288 BOLD percent signal change in vmPFC
Standard Error 2.678
|
|
Functional Magnetic Resonance Imaging (Exploratory Neuroimaging Outcome)
pre-treatment fear condition
|
0.767 BOLD percent signal change in vmPFC
Standard Error 2.506
|
-3.208 BOLD percent signal change in vmPFC
Standard Error 3.393
|
|
Functional Magnetic Resonance Imaging (Exploratory Neuroimaging Outcome)
post-treatment neutral condition
|
-0.781 BOLD percent signal change in vmPFC
Standard Error 2.018
|
-6.917 BOLD percent signal change in vmPFC
Standard Error 2.732
|
|
Functional Magnetic Resonance Imaging (Exploratory Neuroimaging Outcome)
post-treatment fear condition
|
-5.05 BOLD percent signal change in vmPFC
Standard Error 3.112
|
5.472 BOLD percent signal change in vmPFC
Standard Error 4.214
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 10 weeksDiffusion Tensor Imaging (DTI) to assess possible white matter brain changes associated with intervention.
Outcome measures
| Measure |
Pregnenolone
n=13 Participants
Pregnenolone: Pregnenolone 50 mg BID x 14 DAYS, followed by Pregnenolone 150 mg BID x 14 DAYS, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial
|
Placebo
n=7 Participants
Placebo: Same as active comparator, except placebo dispensed.
|
|---|---|---|
|
Diffusion Tensor Imaging (Exploratory Neuroimaging Outcome)
corpus callosum pre-treatment
|
0.5518 fractional anisotropy index units
Standard Error 0.007
|
0.5477 fractional anisotropy index units
Standard Error 0.0088
|
|
Diffusion Tensor Imaging (Exploratory Neuroimaging Outcome)
corpus callosum post-treatment
|
0.5416 fractional anisotropy index units
Standard Error 0.0083
|
0.5432 fractional anisotropy index units
Standard Error 0.0093
|
|
Diffusion Tensor Imaging (Exploratory Neuroimaging Outcome)
anterior corona radiata pre-treatment
|
0.5211 fractional anisotropy index units
Standard Error 0.0082
|
0.5151 fractional anisotropy index units
Standard Error 0.0103
|
|
Diffusion Tensor Imaging (Exploratory Neuroimaging Outcome)
anterior corona radiata post-treatment
|
0.5072 fractional anisotropy index units
Standard Error 0.0089
|
0.5118 fractional anisotropy index units
Standard Error 0.0106
|
|
Diffusion Tensor Imaging (Exploratory Neuroimaging Outcome)
anterior limb of internal capsule pre-treatment
|
0.4750 fractional anisotropy index units
Standard Error 0.0055
|
0.4732 fractional anisotropy index units
Standard Error 0.0080
|
|
Diffusion Tensor Imaging (Exploratory Neuroimaging Outcome)
anterior limb of internal capsule post-treatment
|
0.4670 fractional anisotropy index units
Standard Error 0.0073
|
0.4694 fractional anisotropy index units
Standard Error 0.0081
|
|
Diffusion Tensor Imaging (Exploratory Neuroimaging Outcome)
cerebral peduncle pre-treatment
|
0.5920 fractional anisotropy index units
Standard Error 0.0054
|
0.5812 fractional anisotropy index units
Standard Error 0.0050
|
|
Diffusion Tensor Imaging (Exploratory Neuroimaging Outcome)
cerebral peduncle post-treatment
|
0.5784 fractional anisotropy index units
Standard Error 0.0089
|
0.5797 fractional anisotropy index units
Standard Error 0.0111
|
|
Diffusion Tensor Imaging (Exploratory Neuroimaging Outcome)
cingulum cingulate gyrus pre-treatment
|
0.5729 fractional anisotropy index units
Standard Error 0.0081
|
0.5706 fractional anisotropy index units
Standard Error 0.0079
|
|
Diffusion Tensor Imaging (Exploratory Neuroimaging Outcome)
cingulum cingulate gyrus post-treatment
|
0.5598 fractional anisotropy index units
Standard Error 0.0098
|
0.5663 fractional anisotropy index units
Standard Error 0.0113
|
|
Diffusion Tensor Imaging (Exploratory Neuroimaging Outcome)
cingulum hippocampus pre-treatment
|
0.4379 fractional anisotropy index units
Standard Error 0.0070
|
0.4227 fractional anisotropy index units
Standard Error 0.0095
|
|
Diffusion Tensor Imaging (Exploratory Neuroimaging Outcome)
cingulum hippocampus post-treatment
|
0.4152 fractional anisotropy index units
Standard Error 0.0105
|
0.4210 fractional anisotropy index units
Standard Error 0.0136
|
|
Diffusion Tensor Imaging (Exploratory Neuroimaging Outcome)
corpus callous splenium pre-treatment
|
0.4042 fractional anisotropy index units
Standard Error 0.0116
|
0.4151 fractional anisotropy index units
Standard Error 0.0213
|
|
Diffusion Tensor Imaging (Exploratory Neuroimaging Outcome)
corpus callous splenium post-treatment
|
0.3759 fractional anisotropy index units
Standard Error 0.0177
|
0.3893 fractional anisotropy index units
Standard Error 0.0304
|
|
Diffusion Tensor Imaging (Exploratory Neuroimaging Outcome)
corticospinal tract pre-treatment
|
0.5979 fractional anisotropy index units
Standard Error 0.0068
|
0.5987 fractional anisotropy index units
Standard Error 0.0112
|
|
Diffusion Tensor Imaging (Exploratory Neuroimaging Outcome)
corticospinal tract post-treatment
|
0.5888 fractional anisotropy index units
Standard Error 0.0093
|
0.5891 fractional anisotropy index units
Standard Error 0.0106
|
|
Diffusion Tensor Imaging (Exploratory Neuroimaging Outcome)
external capsule pre-treatment
|
0.4269 fractional anisotropy index units
Standard Error 0.0141
|
0.4407 fractional anisotropy index units
Standard Error 0.0095
|
|
Diffusion Tensor Imaging (Exploratory Neuroimaging Outcome)
external capsule post-treatment
|
0.4236 fractional anisotropy index units
Standard Error 0.0080
|
0.4329 fractional anisotropy index units
Standard Error 0.0099
|
|
Diffusion Tensor Imaging (Exploratory Neuroimaging Outcome)
fornix column pre-treatment
|
0.3944 fractional anisotropy index units
Standard Error 0.0039
|
0.3925 fractional anisotropy index units
Standard Error 0.0082
|
|
Diffusion Tensor Imaging (Exploratory Neuroimaging Outcome)
fornix column post-treatment
|
0.3782 fractional anisotropy index units
Standard Error 0.0081
|
0.3821 fractional anisotropy index units
Standard Error 0.0112
|
|
Diffusion Tensor Imaging (Exploratory Neuroimaging Outcome)
Inferior cerebellar peduncle pre-treatment
|
0.4347 fractional anisotropy index units
Standard Error 0.0073
|
0.4295 fractional anisotropy index units
Standard Error 0.0106
|
|
Diffusion Tensor Imaging (Exploratory Neuroimaging Outcome)
Inferior cerebellar peduncle post-treatment
|
0.4302 fractional anisotropy index units
Standard Error 0.0078
|
0.4254 fractional anisotropy index units
Standard Error 0.0094
|
|
Diffusion Tensor Imaging (Exploratory Neuroimaging Outcome)
Medial Lemniscus pre-treatment
|
0.5100 fractional anisotropy index units
Standard Error 0.0075
|
0.5017 fractional anisotropy index units
Standard Error 0.0094
|
|
Diffusion Tensor Imaging (Exploratory Neuroimaging Outcome)
Medial Lemniscus post-treatment
|
0.4961 fractional anisotropy index units
Standard Error 0.0108
|
0.4933 fractional anisotropy index units
Standard Error 0.0142
|
|
Diffusion Tensor Imaging (Exploratory Neuroimaging Outcome)
Posterior corona radiata pre-treatment
|
0.5071 fractional anisotropy index units
Standard Error 0.0048
|
0.5021 fractional anisotropy index units
Standard Error 0.0096
|
|
Diffusion Tensor Imaging (Exploratory Neuroimaging Outcome)
Posterior corona radiata post-treatment
|
0.4897 fractional anisotropy index units
Standard Error 0.0100
|
0.4943 fractional anisotropy index units
Standard Error 0.0124
|
|
Diffusion Tensor Imaging (Exploratory Neuroimaging Outcome)
Posterior limbs of internal capsule pre-treatment
|
0.5448 fractional anisotropy index units
Standard Error 0.0057
|
0.5319 fractional anisotropy index units
Standard Error 0.0103
|
|
Diffusion Tensor Imaging (Exploratory Neuroimaging Outcome)
Posterior limbs of internal capsule post-treatment
|
0.5252 fractional anisotropy index units
Standard Error 0.0103
|
0.5264 fractional anisotropy index units
Standard Error 0.0118
|
|
Diffusion Tensor Imaging (Exploratory Neuroimaging Outcome)
posterior thalamic radiation pre-treatment
|
0.5819 fractional anisotropy index units
Standard Error 0.0057
|
0.5695 fractional anisotropy index units
Standard Error 0.0085
|
|
Diffusion Tensor Imaging (Exploratory Neuroimaging Outcome)
posterior thalamic radiation post-treatment
|
0.5687 fractional anisotropy index units
Standard Error 0.0094
|
0.5622 fractional anisotropy index units
Standard Error 0.0093
|
|
Diffusion Tensor Imaging (Exploratory Neuroimaging Outcome)
retrolenticular part of internal capsule pre-treat
|
0.5780 fractional anisotropy index units
Standard Error 0.0076
|
0.5569 fractional anisotropy index units
Standard Error 0.0115
|
|
Diffusion Tensor Imaging (Exploratory Neuroimaging Outcome)
retrolenticular part of internal capsule posttreat
|
0.5582 fractional anisotropy index units
Standard Error 0.0106
|
0.5511 fractional anisotropy index units
Standard Error 0.0118
|
|
Diffusion Tensor Imaging (Exploratory Neuroimaging Outcome)
Sagittal Stratum pre-treatment
|
0.5316 fractional anisotropy index units
Standard Error 0.0063
|
0.5136 fractional anisotropy index units
Standard Error 0.0076
|
|
Diffusion Tensor Imaging (Exploratory Neuroimaging Outcome)
Sagittal Stratum post-treatment
|
0.5146 fractional anisotropy index units
Standard Error 0.0112
|
0.5104 fractional anisotropy index units
Standard Error 0.0114
|
|
Diffusion Tensor Imaging (Exploratory Neuroimaging Outcome)
Superior cerebellar peduncle pre-treatment
|
0.5267 fractional anisotropy index units
Standard Error 0.0058
|
0.5291 fractional anisotropy index units
Standard Error 0.0119
|
|
Diffusion Tensor Imaging (Exploratory Neuroimaging Outcome)
Superior cerebellar peduncle post-treatment
|
0.5066 fractional anisotropy index units
Standard Error 0.0112
|
0.5170 fractional anisotropy index units
Standard Error 0.0146
|
|
Diffusion Tensor Imaging (Exploratory Neuroimaging Outcome)
Superior Corona radiata pre-treatment
|
0.5009 fractional anisotropy index units
Standard Error 0.0058
|
0.5091 fractional anisotropy index units
Standard Error 0.0132
|
|
Diffusion Tensor Imaging (Exploratory Neuroimaging Outcome)
Superior Corona radiata post-treatment
|
0.4835 fractional anisotropy index units
Standard Error 0.0100
|
0.5020 fractional anisotropy index units
Standard Error 0.0165
|
|
Diffusion Tensor Imaging (Exploratory Neuroimaging Outcome)
Superior fronto-occipital fasciulus pre-treatment
|
0.4571 fractional anisotropy index units
Standard Error 0.0062
|
0.4574 fractional anisotropy index units
Standard Error 0.0122
|
|
Diffusion Tensor Imaging (Exploratory Neuroimaging Outcome)
Superior fronto-occipital fasciulus post-treatment
|
0.4453 fractional anisotropy index units
Standard Error 0.0085
|
0.4540 fractional anisotropy index units
Standard Error 0.0126
|
|
Diffusion Tensor Imaging (Exploratory Neuroimaging Outcome)
Superior longitudinal fascicles pre-treatment
|
0.4557 fractional anisotropy index units
Standard Error 0.0072
|
0.4464 fractional anisotropy index units
Standard Error 0.0139
|
|
Diffusion Tensor Imaging (Exploratory Neuroimaging Outcome)
Superior longitudinal fascicles post-treatment
|
0.4445 fractional anisotropy index units
Standard Error 0.0087
|
0.4432 fractional anisotropy index units
Standard Error 0.0121
|
|
Diffusion Tensor Imaging (Exploratory Neuroimaging Outcome)
Tapetum pre-treatment
|
0.3758 fractional anisotropy index units
Standard Error 0.0092
|
0.3751 fractional anisotropy index units
Standard Error 0.0086
|
|
Diffusion Tensor Imaging (Exploratory Neuroimaging Outcome)
Tapetum post-treatment
|
0.3645 fractional anisotropy index units
Standard Error 0.0098
|
0.3727 fractional anisotropy index units
Standard Error 0.0082
|
|
Diffusion Tensor Imaging (Exploratory Neuroimaging Outcome)
Uncinate fasciculus pre-treatment
|
0.3997 fractional anisotropy index units
Standard Error 0.0063
|
0.4147 fractional anisotropy index units
Standard Error 0.0096
|
|
Diffusion Tensor Imaging (Exploratory Neuroimaging Outcome)
Uncinate fasciculus post-treatment
|
1.3893 fractional anisotropy index units
Standard Error 0.0072
|
0.4105 fractional anisotropy index units
Standard Error 0.0105
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 10 weeksQuantitative Susceptibility Mapping/Susceptibility Tensor Imaging (QSM/STI) to assess possible myelin brain changes related to the intervention.
Outcome measures
| Measure |
Pregnenolone
n=14 Participants
Pregnenolone: Pregnenolone 50 mg BID x 14 DAYS, followed by Pregnenolone 150 mg BID x 14 DAYS, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial
|
Placebo
n=10 Participants
Placebo: Same as active comparator, except placebo dispensed.
|
|---|---|---|
|
Quantitative Susceptibility Mapping/Susceptibility Tensor Imaging (Exploratory Neuroimaging Outcome)
tapetum pre-treatment
|
0.0031 magnetic susceptibility ratio
Standard Error 0.0023
|
0.0023 magnetic susceptibility ratio
Standard Error 0.0016
|
|
Quantitative Susceptibility Mapping/Susceptibility Tensor Imaging (Exploratory Neuroimaging Outcome)
uncinate fasciculus pre-treatment
|
0.0219 magnetic susceptibility ratio
Standard Error 0.0038
|
0.0268 magnetic susceptibility ratio
Standard Error 0.0021
|
|
Quantitative Susceptibility Mapping/Susceptibility Tensor Imaging (Exploratory Neuroimaging Outcome)
red nucleus pre-treatment
|
-0.0236 magnetic susceptibility ratio
Standard Error 0.0057
|
-0.0253 magnetic susceptibility ratio
Standard Error 0.0038
|
|
Quantitative Susceptibility Mapping/Susceptibility Tensor Imaging (Exploratory Neuroimaging Outcome)
red nucleus post-treatment
|
-0.0246 magnetic susceptibility ratio
Standard Error 0.0031
|
-0.0312 magnetic susceptibility ratio
Standard Error 0.0053
|
|
Quantitative Susceptibility Mapping/Susceptibility Tensor Imaging (Exploratory Neuroimaging Outcome)
substantia nigra pre-treatment
|
-0.0376 magnetic susceptibility ratio
Standard Error 0.0085
|
-0.0399 magnetic susceptibility ratio
Standard Error 0.0047
|
|
Quantitative Susceptibility Mapping/Susceptibility Tensor Imaging (Exploratory Neuroimaging Outcome)
substantia nigra post-treatment
|
-0.0456 magnetic susceptibility ratio
Standard Error 0.0034
|
-0.0481 magnetic susceptibility ratio
Standard Error 0.0048
|
|
Quantitative Susceptibility Mapping/Susceptibility Tensor Imaging (Exploratory Neuroimaging Outcome)
pulvinar pre-treatment
|
-0.0421 magnetic susceptibility ratio
Standard Error 0.0035
|
-0.0395 magnetic susceptibility ratio
Standard Error 0.0055
|
|
Quantitative Susceptibility Mapping/Susceptibility Tensor Imaging (Exploratory Neuroimaging Outcome)
pulvinar post-treatment
|
-0.0391 magnetic susceptibility ratio
Standard Error 00035
|
-0.0427 magnetic susceptibility ratio
Standard Error 0.0078
|
|
Quantitative Susceptibility Mapping/Susceptibility Tensor Imaging (Exploratory Neuroimaging Outcome)
dentate nucleus pre-treamtment
|
-0.0071 magnetic susceptibility ratio
Standard Error 0.0046
|
-0.0059 magnetic susceptibility ratio
Standard Error 0.0056
|
|
Quantitative Susceptibility Mapping/Susceptibility Tensor Imaging (Exploratory Neuroimaging Outcome)
dentate nucleus post-treatment
|
-0.0116 magnetic susceptibility ratio
Standard Error 0.0033
|
-0.0092 magnetic susceptibility ratio
Standard Error 0.0066
|
|
Quantitative Susceptibility Mapping/Susceptibility Tensor Imaging (Exploratory Neuroimaging Outcome)
corpus callosum genu pre-treatment
|
0.0093 magnetic susceptibility ratio
Standard Error 0.0015
|
0.0045 magnetic susceptibility ratio
Standard Error 0.0034
|
|
Quantitative Susceptibility Mapping/Susceptibility Tensor Imaging (Exploratory Neuroimaging Outcome)
corpus callosum genu post-treatment
|
0.0096 magnetic susceptibility ratio
Standard Error 0.0027
|
-0.0011 magnetic susceptibility ratio
Standard Error 0.0031
|
|
Quantitative Susceptibility Mapping/Susceptibility Tensor Imaging (Exploratory Neuroimaging Outcome)
corpus callosum body pre-treatment
|
0.0049 magnetic susceptibility ratio
Standard Error 0.0020
|
0.0063 magnetic susceptibility ratio
Standard Error 0.0019
|
|
Quantitative Susceptibility Mapping/Susceptibility Tensor Imaging (Exploratory Neuroimaging Outcome)
corpus callosum body post-treatment
|
0.0036 magnetic susceptibility ratio
Standard Error 0.0018
|
0.0059 magnetic susceptibility ratio
Standard Error 0.0046
|
|
Quantitative Susceptibility Mapping/Susceptibility Tensor Imaging (Exploratory Neuroimaging Outcome)
anterior corona radiata pre-treatment
|
0.0142 magnetic susceptibility ratio
Standard Error 0.0025
|
0.0060 magnetic susceptibility ratio
Standard Error 0.0012
|
|
Quantitative Susceptibility Mapping/Susceptibility Tensor Imaging (Exploratory Neuroimaging Outcome)
anterior corona radiata post-treatment
|
0.0084 magnetic susceptibility ratio
Standard Error 0.0024
|
0.0025 magnetic susceptibility ratio
Standard Error 0.0015
|
|
Quantitative Susceptibility Mapping/Susceptibility Tensor Imaging (Exploratory Neuroimaging Outcome)
anterior limb internal capsule pre-treatment
|
0.0094 magnetic susceptibility ratio
Standard Error 0.0028
|
0.0047 magnetic susceptibility ratio
Standard Error 0.0034
|
|
Quantitative Susceptibility Mapping/Susceptibility Tensor Imaging (Exploratory Neuroimaging Outcome)
anterior limb internal capsule post-treatment
|
0.0099 magnetic susceptibility ratio
Standard Error 0.0022
|
0.0036 magnetic susceptibility ratio
Standard Error 0.0026
|
|
Quantitative Susceptibility Mapping/Susceptibility Tensor Imaging (Exploratory Neuroimaging Outcome)
cerebral peduncle pre-treatment
|
0.0141 magnetic susceptibility ratio
Standard Error 0.0040
|
0.134 magnetic susceptibility ratio
Standard Error 0.004
|
|
Quantitative Susceptibility Mapping/Susceptibility Tensor Imaging (Exploratory Neuroimaging Outcome)
cerebral peduncle post-treatment
|
0.0133 magnetic susceptibility ratio
Standard Error 0.0033
|
0.0036 magnetic susceptibility ratio
Standard Error 0.0034
|
|
Quantitative Susceptibility Mapping/Susceptibility Tensor Imaging (Exploratory Neuroimaging Outcome)
cingulate cingulum pre-treatment
|
0.0016 magnetic susceptibility ratio
Standard Error 0.0011
|
0.0021 magnetic susceptibility ratio
Standard Error 0.0019
|
|
Quantitative Susceptibility Mapping/Susceptibility Tensor Imaging (Exploratory Neuroimaging Outcome)
cingulate cingulum post-treatment
|
0.0017 magnetic susceptibility ratio
Standard Error 0.0008
|
0.0037 magnetic susceptibility ratio
Standard Error 0.002
|
|
Quantitative Susceptibility Mapping/Susceptibility Tensor Imaging (Exploratory Neuroimaging Outcome)
cingulum hippocampus pre-treatment
|
-0.00630 magnetic susceptibility ratio
Standard Error 0.0024
|
-0.0042 magnetic susceptibility ratio
Standard Error 0.0024
|
|
Quantitative Susceptibility Mapping/Susceptibility Tensor Imaging (Exploratory Neuroimaging Outcome)
cingulum hippocampus post-treatment
|
-0.0041 magnetic susceptibility ratio
Standard Error 0.0008
|
-0.0042 magnetic susceptibility ratio
Standard Error 0.0031
|
|
Quantitative Susceptibility Mapping/Susceptibility Tensor Imaging (Exploratory Neuroimaging Outcome)
corpus callosum splenium pre-treatment
|
0.0149 magnetic susceptibility ratio
Standard Error 0.0011
|
0.0146 magnetic susceptibility ratio
Standard Error 0.0014
|
|
Quantitative Susceptibility Mapping/Susceptibility Tensor Imaging (Exploratory Neuroimaging Outcome)
corpus callosum splenium post-treatment
|
0.0103 magnetic susceptibility ratio
Standard Error 0.0018
|
0.0098 magnetic susceptibility ratio
Standard Error 0.0007
|
|
Quantitative Susceptibility Mapping/Susceptibility Tensor Imaging (Exploratory Neuroimaging Outcome)
cortico-spinal pre-treatment
|
0.0209 magnetic susceptibility ratio
Standard Error 0.0023
|
0.0168 magnetic susceptibility ratio
Standard Error 0.0012
|
|
Quantitative Susceptibility Mapping/Susceptibility Tensor Imaging (Exploratory Neuroimaging Outcome)
cortico-spinal post-treatment
|
0.0178 magnetic susceptibility ratio
Standard Error 0.0008
|
0.0166 magnetic susceptibility ratio
Standard Error 0.0018
|
|
Quantitative Susceptibility Mapping/Susceptibility Tensor Imaging (Exploratory Neuroimaging Outcome)
external capsule pre-treatment
|
0.0002 magnetic susceptibility ratio
Standard Error 0.006
|
0.0054 magnetic susceptibility ratio
Standard Error 0.0009
|
|
Quantitative Susceptibility Mapping/Susceptibility Tensor Imaging (Exploratory Neuroimaging Outcome)
external capsule post-treatment
|
0.0048 magnetic susceptibility ratio
Standard Error 0.0011
|
0.0074 magnetic susceptibility ratio
Standard Error 0.0011
|
|
Quantitative Susceptibility Mapping/Susceptibility Tensor Imaging (Exploratory Neuroimaging Outcome)
fornix column body pre-treatment
|
-0.0118 magnetic susceptibility ratio
Standard Error 0.0048
|
-0.0171 magnetic susceptibility ratio
Standard Error 0.0028
|
|
Quantitative Susceptibility Mapping/Susceptibility Tensor Imaging (Exploratory Neuroimaging Outcome)
fornix column body post-treatment
|
-0.011 magnetic susceptibility ratio
Standard Error 0.0041
|
-0.0221 magnetic susceptibility ratio
Standard Error 0.0014
|
|
Quantitative Susceptibility Mapping/Susceptibility Tensor Imaging (Exploratory Neuroimaging Outcome)
interior cerebellar peduncle pre-treatment
|
0.0120 magnetic susceptibility ratio
Standard Error 0.0018
|
0.0118 magnetic susceptibility ratio
Standard Error 0.0011
|
|
Quantitative Susceptibility Mapping/Susceptibility Tensor Imaging (Exploratory Neuroimaging Outcome)
interior cerebellar peduncle post-treatment
|
0.0088 magnetic susceptibility ratio
Standard Error 0.0009
|
0.0119 magnetic susceptibility ratio
Standard Error 0.0015
|
|
Quantitative Susceptibility Mapping/Susceptibility Tensor Imaging (Exploratory Neuroimaging Outcome)
medial lemniscus pre-treatment
|
0.0236 magnetic susceptibility ratio
Standard Error 0.0015
|
0.0197 magnetic susceptibility ratio
Standard Error 0.0014
|
|
Quantitative Susceptibility Mapping/Susceptibility Tensor Imaging (Exploratory Neuroimaging Outcome)
medial lemniscus post-treatment
|
0.0212 magnetic susceptibility ratio
Standard Error 0.0018
|
0.0217 magnetic susceptibility ratio
Standard Error 0.0022
|
|
Quantitative Susceptibility Mapping/Susceptibility Tensor Imaging (Exploratory Neuroimaging Outcome)
posterior corona radiate pre-treatment
|
0.0133 magnetic susceptibility ratio
Standard Error 0.0014
|
0.0121 magnetic susceptibility ratio
Standard Error 0.0011
|
|
Quantitative Susceptibility Mapping/Susceptibility Tensor Imaging (Exploratory Neuroimaging Outcome)
posterior corona radiate post-treatment
|
0.144 magnetic susceptibility ratio
Standard Error 0.0009
|
0.0131 magnetic susceptibility ratio
Standard Error 0.0007
|
|
Quantitative Susceptibility Mapping/Susceptibility Tensor Imaging (Exploratory Neuroimaging Outcome)
posterior limb internal capsule pre-treatment
|
0.0270 magnetic susceptibility ratio
Standard Error 0.0026
|
0.0267 magnetic susceptibility ratio
Standard Error 0.0018
|
|
Quantitative Susceptibility Mapping/Susceptibility Tensor Imaging (Exploratory Neuroimaging Outcome)
posterior limb internal capsule post-treatment
|
0.0292 magnetic susceptibility ratio
Standard Error 0.0014
|
0.0267 magnetic susceptibility ratio
Standard Error 0.0017
|
|
Quantitative Susceptibility Mapping/Susceptibility Tensor Imaging (Exploratory Neuroimaging Outcome)
posterior thalamic radiation pre-treatment
|
0.0184 magnetic susceptibility ratio
Standard Error 0.0015
|
0.0181 magnetic susceptibility ratio
Standard Error 0.0009
|
|
Quantitative Susceptibility Mapping/Susceptibility Tensor Imaging (Exploratory Neuroimaging Outcome)
posterior thalamic radiation post-treatment
|
0.0201 magnetic susceptibility ratio
Standard Error 0.001
|
0.0199 magnetic susceptibility ratio
Standard Error 0.0013
|
|
Quantitative Susceptibility Mapping/Susceptibility Tensor Imaging (Exploratory Neuroimaging Outcome)
retrolenticular internal capsule pre-treatment
|
0.0018 magnetic susceptibility ratio
Standard Error 0.0058
|
0.0039 magnetic susceptibility ratio
Standard Error 0.0022
|
|
Quantitative Susceptibility Mapping/Susceptibility Tensor Imaging (Exploratory Neuroimaging Outcome)
retrolenticular internal capsule post-treatment
|
0.0077 magnetic susceptibility ratio
Standard Error 0.0009
|
0.0043 magnetic susceptibility ratio
Standard Error 0.0016
|
|
Quantitative Susceptibility Mapping/Susceptibility Tensor Imaging (Exploratory Neuroimaging Outcome)
sagittal stratum pre-treatment
|
0.0145 magnetic susceptibility ratio
Standard Error 0.0016
|
0.0138 magnetic susceptibility ratio
Standard Error 0.0025
|
|
Quantitative Susceptibility Mapping/Susceptibility Tensor Imaging (Exploratory Neuroimaging Outcome)
sagittal stratum post-treatment
|
0.0148 magnetic susceptibility ratio
Standard Error 0.0010
|
0.0160 magnetic susceptibility ratio
Standard Error 0.0011
|
|
Quantitative Susceptibility Mapping/Susceptibility Tensor Imaging (Exploratory Neuroimaging Outcome)
superior cerebellar peduncle pre-treatment
|
0.0049 magnetic susceptibility ratio
Standard Error 0.0016
|
0.0076 magnetic susceptibility ratio
Standard Error 0.0028
|
|
Quantitative Susceptibility Mapping/Susceptibility Tensor Imaging (Exploratory Neuroimaging Outcome)
superior cerebellar peduncle post-treatment
|
0.0055 magnetic susceptibility ratio
Standard Error 0.0019
|
0.0082 magnetic susceptibility ratio
Standard Error 0.0025
|
|
Quantitative Susceptibility Mapping/Susceptibility Tensor Imaging (Exploratory Neuroimaging Outcome)
superior corona radiata pre-treatment
|
0.0086 magnetic susceptibility ratio
Standard Error 0.0014
|
0.0090 magnetic susceptibility ratio
Standard Error 0.0008
|
|
Quantitative Susceptibility Mapping/Susceptibility Tensor Imaging (Exploratory Neuroimaging Outcome)
superior corona radiata post-treatment
|
0.0096 magnetic susceptibility ratio
Standard Error 0.0006
|
0.0098 magnetic susceptibility ratio
Standard Error 0.0007
|
|
Quantitative Susceptibility Mapping/Susceptibility Tensor Imaging (Exploratory Neuroimaging Outcome)
superior fronto-occipital fasciculus pre-treatment
|
0.0033 magnetic susceptibility ratio
Standard Error 0.0017
|
0.0061 magnetic susceptibility ratio
Standard Error 0.0018
|
|
Quantitative Susceptibility Mapping/Susceptibility Tensor Imaging (Exploratory Neuroimaging Outcome)
superior fronto-occipital fasciculus post-treatmt
|
0.0021 magnetic susceptibility ratio
Standard Error 0.0016
|
0.0064 magnetic susceptibility ratio
Standard Error 0.0018
|
|
Quantitative Susceptibility Mapping/Susceptibility Tensor Imaging (Exploratory Neuroimaging Outcome)
superior longitudinal fasciculus pre-treatment
|
0.0024 magnetic susceptibility ratio
Standard Error 0.0028
|
0.0047 magnetic susceptibility ratio
Standard Error 0.0007
|
|
Quantitative Susceptibility Mapping/Susceptibility Tensor Imaging (Exploratory Neuroimaging Outcome)
superior longitudinal fasciculus post-treatment
|
0.0049 magnetic susceptibility ratio
Standard Error 0.0005
|
0.0055 magnetic susceptibility ratio
Standard Error 0.0011
|
|
Quantitative Susceptibility Mapping/Susceptibility Tensor Imaging (Exploratory Neuroimaging Outcome)
tapetum post-treatment
|
0.0015 magnetic susceptibility ratio
Standard Error 0.0017
|
0.0045 magnetic susceptibility ratio
Standard Error 0.0016
|
|
Quantitative Susceptibility Mapping/Susceptibility Tensor Imaging (Exploratory Neuroimaging Outcome)
uncinate fasciculus post-treatment
|
0.0250 magnetic susceptibility ratio
Standard Error 0.0016
|
0.0260 magnetic susceptibility ratio
Standard Error 0.0031
|
Adverse Events
Pregnenolone
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Pregnenolone
n=27 participants at risk
Pregnenolone: Pregnenolone 50 mg BID x 14 DAYS, followed by Pregnenolone 150 mg BID x 14 DAYS, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial
|
Placebo
n=26 participants at risk
Placebo: Same as active comparator, except placebo dispensed.
|
|---|---|---|
|
General disorders
Headache
|
55.6%
15/27 • Number of events 30
|
38.5%
10/26 • Number of events 26
|
|
Skin and subcutaneous tissue disorders
Dermatological
|
22.2%
6/27 • Number of events 8
|
3.8%
1/26 • Number of events 1
|
|
General disorders
Restlessness
|
18.5%
5/27 • Number of events 6
|
11.5%
3/26 • Number of events 6
|
|
General disorders
Insomnia
|
7.4%
2/27 • Number of events 5
|
7.7%
2/26 • Number of events 3
|
|
General disorders
Irritabilty
|
11.1%
3/27 • Number of events 3
|
7.7%
2/26 • Number of events 3
|
|
General disorders
Dry Mouth
|
11.1%
3/27 • Number of events 3
|
15.4%
4/26 • Number of events 9
|
|
Gastrointestinal disorders
Diarrhea
|
7.4%
2/27 • Number of events 3
|
0.00%
0/26
|
|
General disorders
Akathisia
|
7.4%
2/27 • Number of events 2
|
0.00%
0/26
|
|
Gastrointestinal disorders
Constipation
|
3.7%
1/27 • Number of events 2
|
3.8%
1/26 • Number of events 1
|
|
General disorders
Nasal Congestion
|
7.4%
2/27 • Number of events 2
|
3.8%
1/26 • Number of events 1
|
|
General disorders
Nausea
|
3.7%
1/27 • Number of events 1
|
11.5%
3/26 • Number of events 4
|
|
General disorders
Malaise
|
3.7%
1/27 • Number of events 1
|
0.00%
0/26
|
|
General disorders
Tremor
|
3.7%
1/27 • Number of events 1
|
3.8%
1/26 • Number of events 1
|
|
General disorders
Decreased Appetite
|
3.7%
1/27 • Number of events 1
|
0.00%
0/26
|
|
General disorders
Decreased Motor Activity
|
3.7%
1/27 • Number of events 1
|
0.00%
0/26
|
|
General disorders
Drowsiness
|
3.7%
1/27 • Number of events 1
|
3.8%
1/26 • Number of events 1
|
|
General disorders
Increased Motor Activity
|
3.7%
1/27 • Number of events 1
|
0.00%
0/26
|
|
Musculoskeletal and connective tissue disorders
Joint Pain/Stiffness
|
3.7%
1/27 • Number of events 1
|
0.00%
0/26
|
|
Musculoskeletal and connective tissue disorders
Muscle Pain/Stiffness
|
3.7%
1/27 • Number of events 1
|
0.00%
0/26
|
|
General disorders
Paresthesia
|
3.7%
1/27 • Number of events 1
|
0.00%
0/26
|
|
Ear and labyrinth disorders
Tinnitus
|
3.7%
1/27 • Number of events 1
|
0.00%
0/26
|
|
Eye disorders
Blurred Vision
|
0.00%
0/27
|
3.8%
1/26 • Number of events 1
|
|
General disorders
Cramps
|
0.00%
0/27
|
3.8%
1/26 • Number of events 1
|
|
General disorders
Increased Appetite
|
0.00%
0/27
|
3.8%
1/26 • Number of events 2
|
|
General disorders
Sweating
|
0.00%
0/27
|
3.8%
1/26 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place