Trial Outcomes & Findings for Perampanel Titration and Cognitive Effects (NCT NCT04417907)
NCT ID: NCT04417907
Last Updated: 2024-06-06
Results Overview
Z score of cognitive tests (selected performance measures from the computerized cognitive test battery) and questionnaires (AEP, POMS, QOLIE-cognitive questions) at the end of each week of drug treatment for each titration arm, controlling for baseline measures collected prior to treatment. Various measures were combined collectively (averaged) to compute an overall Z-score for each group at each time point. These included: 1) Executive Function Score of computerized test battery; 2) Processing Speed Score of computerized test battery; 3) AEP total score; 4) POMS total and domain scores; 5) Three cognitive components of the QOLIE-31 (attention, memory, language). The Z-score indicates the number of standard deviations away from a reference population. A Z-score of 0 is equal to the mean. Negative numbers indicate poorer performance compared to the mean and positive numbers represent higher performance compared to the mean.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
29 participants
Primary outcome timeframe
At the end of each week of treatment for 6 weeks.
Results posted on
2024-06-06
Participant Flow
Participant milestones
| Measure |
Placebo
Participants take 2mg placebo PO QD for six weeks.
|
PER 1 Week Titration
Participants take 2mg perampanel PO QD for one week and 4mg perampanel PO QD for five weeks.
|
PER 2 Week Titration
Participants take 2mg perampanel PO QD for two weeks and 4mg perampanel PO QD for four weeks.
|
PER 4 mg
Participants take 4mg perampanel PO QD for six weeks
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
7
|
7
|
11
|
|
Overall Study
COMPLETED
|
2
|
3
|
6
|
8
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
1
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Perampanel Titration and Cognitive Effects
Baseline characteristics by cohort
| Measure |
Placebo
n=4 Participants
Participants take 2mg placebo PO QD for six weeks.
|
PER 1 Week Titration
n=7 Participants
Participants take 2mg perampanel PO QD for one week and 4mg perampanel PO QD for five weeks.
|
PER 2 Week Titration
n=7 Participants
Participants take 2mg perampanel PO QD for two weeks and 4mg perampanel PO QD for four weeks.
|
PER 4 mg
n=11 Participants
Participants take 4mg perampanel PO QD for six weeks
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
44.8 Years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
34.7 Years
STANDARD_DEVIATION 10.3 • n=7 Participants
|
30.3 Years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
39.7 Years
STANDARD_DEVIATION 12.8 • n=4 Participants
|
36.9 Years
STANDARD_DEVIATION 11.6 • n=21 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
7 participants
n=7 Participants
|
7 participants
n=5 Participants
|
11 participants
n=4 Participants
|
29 participants
n=21 Participants
|
|
Education Level
|
16 Years
STANDARD_DEVIATION 1.6 • n=5 Participants
|
17 Years
STANDARD_DEVIATION 1.9 • n=7 Participants
|
16 Years
STANDARD_DEVIATION 1.2 • n=5 Participants
|
15.7 Years
STANDARD_DEVIATION 2.2 • n=4 Participants
|
16.1 Years
STANDARD_DEVIATION 1.8 • n=21 Participants
|
|
IQ Estimate
|
99 units on a scale
STANDARD_DEVIATION 7.1 • n=5 Participants
|
102.3 units on a scale
STANDARD_DEVIATION 6.7 • n=7 Participants
|
97.1 units on a scale
STANDARD_DEVIATION 11 • n=5 Participants
|
102.9 units on a scale
STANDARD_DEVIATION 7.4 • n=4 Participants
|
100.8 units on a scale
STANDARD_DEVIATION 8.2 • n=21 Participants
|
PRIMARY outcome
Timeframe: At the end of each week of treatment for 6 weeks.Population: Participants who completed the protocol are included in the analysis.
Z score of cognitive tests (selected performance measures from the computerized cognitive test battery) and questionnaires (AEP, POMS, QOLIE-cognitive questions) at the end of each week of drug treatment for each titration arm, controlling for baseline measures collected prior to treatment. Various measures were combined collectively (averaged) to compute an overall Z-score for each group at each time point. These included: 1) Executive Function Score of computerized test battery; 2) Processing Speed Score of computerized test battery; 3) AEP total score; 4) POMS total and domain scores; 5) Three cognitive components of the QOLIE-31 (attention, memory, language). The Z-score indicates the number of standard deviations away from a reference population. A Z-score of 0 is equal to the mean. Negative numbers indicate poorer performance compared to the mean and positive numbers represent higher performance compared to the mean.
Outcome measures
| Measure |
Placebo
n=2 Participants
Participants take 2mg placebo PO QD for six weeks.
|
PER 1 Week Titration
n=3 Participants
Participants take 2mg perampanel PO QD for one week and 4mg perampanel PO QD for five weeks.
|
PER 2 Week Titration
n=6 Participants
Participants take 2mg perampanel PO QD for two weeks and 4mg perampanel PO QD for four weeks.
|
PER 4 mg
n=8 Participants
Participants take 4mg perampanel PO QD for six weeks
|
|---|---|---|---|---|
|
Overall Neuropsychological Composite Z-score as a Measure of Direct Comparison of the 4 Titration Conditions Across 6 Weeks of Treatment.
Week 1
|
-.41 score on a scale
Standard Deviation 1.00
|
-.07 score on a scale
Standard Deviation .55
|
.05 score on a scale
Standard Deviation .28
|
.32 score on a scale
Standard Deviation .33
|
|
Overall Neuropsychological Composite Z-score as a Measure of Direct Comparison of the 4 Titration Conditions Across 6 Weeks of Treatment.
Week 2
|
-.25 score on a scale
Standard Deviation .90
|
-.01 score on a scale
Standard Deviation .44
|
-.15 score on a scale
Standard Deviation .26
|
.15 score on a scale
Standard Deviation .27
|
|
Overall Neuropsychological Composite Z-score as a Measure of Direct Comparison of the 4 Titration Conditions Across 6 Weeks of Treatment.
Week 3
|
-.14 score on a scale
Standard Deviation .71
|
-.03 score on a scale
Standard Deviation .36
|
.02 score on a scale
Standard Deviation .34
|
.10 score on a scale
Standard Deviation .34
|
|
Overall Neuropsychological Composite Z-score as a Measure of Direct Comparison of the 4 Titration Conditions Across 6 Weeks of Treatment.
Week 4
|
-.32 score on a scale
Standard Deviation .81
|
-.06 score on a scale
Standard Deviation .40
|
.09 score on a scale
Standard Deviation .49
|
.23 score on a scale
Standard Deviation .33
|
|
Overall Neuropsychological Composite Z-score as a Measure of Direct Comparison of the 4 Titration Conditions Across 6 Weeks of Treatment.
Week 5
|
-.34 score on a scale
Standard Deviation .85
|
-.11 score on a scale
Standard Deviation .53
|
-.03 score on a scale
Standard Deviation .35
|
.37 score on a scale
Standard Deviation .41
|
|
Overall Neuropsychological Composite Z-score as a Measure of Direct Comparison of the 4 Titration Conditions Across 6 Weeks of Treatment.
Week 6
|
-.28 score on a scale
Standard Deviation .87
|
-.03 score on a scale
Standard Deviation .45
|
-.11 score on a scale
Standard Deviation .35
|
.21 score on a scale
Standard Deviation .48
|
PRIMARY outcome
Timeframe: At the end of each week of treatment for 6 weeks.Population: Participants who completed the protocol are included in the analysis.
Z score of objective cognitive tests (selected performance measures from the computerized cognitive test battery) at the end of each week of drug treatment for each titration arm, controlling for baseline measures collected prior to treatment. The Z-score indicates the number of standard deviations away from a reference population. A Z-score of 0 is equal to the mean. Negative numbers indicate poorer performance compared to the mean and positive numbers represent higher performance compared to the mean.
Outcome measures
| Measure |
Placebo
n=2 Participants
Participants take 2mg placebo PO QD for six weeks.
|
PER 1 Week Titration
n=3 Participants
Participants take 2mg perampanel PO QD for one week and 4mg perampanel PO QD for five weeks.
|
PER 2 Week Titration
n=6 Participants
Participants take 2mg perampanel PO QD for two weeks and 4mg perampanel PO QD for four weeks.
|
PER 4 mg
n=8 Participants
Participants take 4mg perampanel PO QD for six weeks
|
|---|---|---|---|---|
|
Composite Z-score of Objective Measures as a Measure of Direct Comparison of the 4 Titration Conditions Across 6 Weeks of Treatment.
Week 1
|
-.69 score on a scale
Standard Deviation .52
|
.61 score on a scale
Standard Deviation .21
|
.04 score on a scale
Standard Deviation .38
|
.11 score on a scale
Standard Deviation .23
|
|
Composite Z-score of Objective Measures as a Measure of Direct Comparison of the 4 Titration Conditions Across 6 Weeks of Treatment.
Week 2
|
.26 score on a scale
Standard Deviation .03
|
.44 score on a scale
Standard Deviation .20
|
-.05 score on a scale
Standard Deviation .02
|
.11 score on a scale
Standard Deviation .40
|
|
Composite Z-score of Objective Measures as a Measure of Direct Comparison of the 4 Titration Conditions Across 6 Weeks of Treatment.
Week 3
|
.04 score on a scale
Standard Deviation .30
|
.24 score on a scale
Standard Deviation .30
|
.05 score on a scale
Standard Deviation .12
|
.11 score on a scale
Standard Deviation .11
|
|
Composite Z-score of Objective Measures as a Measure of Direct Comparison of the 4 Titration Conditions Across 6 Weeks of Treatment.
Week 4
|
.51 score on a scale
Standard Deviation .15
|
.28 score on a scale
Standard Deviation .23
|
-.17 score on a scale
Standard Deviation .38
|
.27 score on a scale
Standard Deviation .31
|
|
Composite Z-score of Objective Measures as a Measure of Direct Comparison of the 4 Titration Conditions Across 6 Weeks of Treatment.
Week 5
|
.06 score on a scale
Standard Deviation .19
|
.33 score on a scale
Standard Deviation .02
|
-.15 score on a scale
Standard Deviation .01
|
.07 score on a scale
Standard Deviation .08
|
|
Composite Z-score of Objective Measures as a Measure of Direct Comparison of the 4 Titration Conditions Across 6 Weeks of Treatment.
Week 6
|
.28 score on a scale
Standard Deviation .25
|
.11 score on a scale
Standard Deviation .38
|
-.21 score on a scale
Standard Deviation .34
|
-.06 score on a scale
Standard Deviation .37
|
PRIMARY outcome
Timeframe: At the end of each week of treatment for 6 weeks.Population: Participants who completed the protocol are included in the analysis.
Z score of subjective questionnaires (AEP, POMS, QOLIE-cognitive questions at the end of each week of drug treatment for each titration arm, controlling for baseline measures collected prior to treatment. Various measures were combined collectively (averaged) to compute an overall Z-score for each group at each time point. These included: 1) AEP total score; 2) POMS total and domain scores; 3) Three cognitive components of the QOLIE-31 (attention, memory, language). The Z-score indicates the number of standard deviations away from a reference population. A Z-score of 0 is equal to the mean. Negative numbers indicate poorer performance compared to the mean and positive numbers represent higher performance compared to the mean.
Outcome measures
| Measure |
Placebo
n=2 Participants
Participants take 2mg placebo PO QD for six weeks.
|
PER 1 Week Titration
n=3 Participants
Participants take 2mg perampanel PO QD for one week and 4mg perampanel PO QD for five weeks.
|
PER 2 Week Titration
n=6 Participants
Participants take 2mg perampanel PO QD for two weeks and 4mg perampanel PO QD for four weeks.
|
PER 4 mg
n=8 Participants
Participants take 4mg perampanel PO QD for six weeks
|
|---|---|---|---|---|
|
Composite Z-score of Subjective Measures as a Measure of Direct Comparison of the 4 Titration Conditions Across 6 Weeks of Treatment.
Week 1
|
-.36 score on a scale
Standard Deviation 1.08
|
-.20 score on a scale
Standard Deviation .50
|
.05 score on a scale
Standard Deviation .28
|
.36 score on a scale
Standard Deviation .34
|
|
Composite Z-score of Subjective Measures as a Measure of Direct Comparison of the 4 Titration Conditions Across 6 Weeks of Treatment.
Week 2
|
-.35 score on a scale
Standard Deviation .96
|
-.09 score on a scale
Standard Deviation .43
|
-.17 score on a scale
Standard Deviation .28
|
.16 score on a scale
Standard Deviation .27
|
|
Composite Z-score of Subjective Measures as a Measure of Direct Comparison of the 4 Titration Conditions Across 6 Weeks of Treatment.
Week 3
|
-.28 score on a scale
Standard Deviation .89
|
-.23 score on a scale
Standard Deviation .28
|
.04 score on a scale
Standard Deviation .44
|
.28 score on a scale
Standard Deviation .26
|
|
Composite Z-score of Subjective Measures as a Measure of Direct Comparison of the 4 Titration Conditions Across 6 Weeks of Treatment.
Week 4
|
-.47 score on a scale
Standard Deviation .79
|
-.12 score on a scale
Standard Deviation .40
|
.14 score on a scale
Standard Deviation .51
|
.27 score on a scale
Standard Deviation .32
|
|
Composite Z-score of Subjective Measures as a Measure of Direct Comparison of the 4 Titration Conditions Across 6 Weeks of Treatment.
Week 5
|
-.41 score on a scale
Standard Deviation .91
|
-.19 score on a scale
Standard Deviation .54
|
-.01 score on a scale
Standard Deviation .38
|
.42 score on a scale
Standard Deviation .43
|
|
Composite Z-score of Subjective Measures as a Measure of Direct Comparison of the 4 Titration Conditions Across 6 Weeks of Treatment.
Week 6
|
-.69 score on a scale
Standard Deviation .93
|
-.14 score on a scale
Standard Deviation .49
|
-.03 score on a scale
Standard Deviation .36
|
.41 score on a scale
Standard Deviation .45
|
SECONDARY outcome
Timeframe: At the end of each week of treatment for 6 weeks.Population: All participants who completed the protocol are included in the analysis. However, zero participants withdrew from the study after starting the study drug.
Number of TEAEs across the the four titration conditions over the six-week treatment period. A score of 0 indicates no TEAEs. Higher numbers indicate greater TEAEs.
Outcome measures
| Measure |
Placebo
n=2 Participants
Participants take 2mg placebo PO QD for six weeks.
|
PER 1 Week Titration
n=3 Participants
Participants take 2mg perampanel PO QD for one week and 4mg perampanel PO QD for five weeks.
|
PER 2 Week Titration
n=6 Participants
Participants take 2mg perampanel PO QD for two weeks and 4mg perampanel PO QD for four weeks.
|
PER 4 mg
n=8 Participants
Participants take 4mg perampanel PO QD for six weeks
|
|---|---|---|---|---|
|
Treatment Emergent Adverse Events (TEAEs) Across the Six-week Treatment Period Measure of Direct Comparison of the 4 Titration Conditions Across 6 Weeks of Treatment.
|
5 TEAEs
|
9 TEAEs
|
9 TEAEs
|
11 TEAEs
|
SECONDARY outcome
Timeframe: At the end of each week of treatment for 6 weeks.Population: All participants included in analysis. However, zero participants withdrew from the study after starting the study drug.
Number dropouts across the the four titration conditions over the six-week treatment period. A score of 0 indicates no dropouts. Higher numbers indicate greater dropouts.
Outcome measures
| Measure |
Placebo
n=2 Participants
Participants take 2mg placebo PO QD for six weeks.
|
PER 1 Week Titration
n=3 Participants
Participants take 2mg perampanel PO QD for one week and 4mg perampanel PO QD for five weeks.
|
PER 2 Week Titration
n=6 Participants
Participants take 2mg perampanel PO QD for two weeks and 4mg perampanel PO QD for four weeks.
|
PER 4 mg
n=8 Participants
Participants take 4mg perampanel PO QD for six weeks
|
|---|---|---|---|---|
|
Dropouts Across the Six-week Treatment Period Measure of Direct Comparison of the 4 Titration Conditions Across 6 Weeks of Treatment.
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
PER 1 Week Titration
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
PER 2 Week Titration
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
PER 4 mg
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=2 participants at risk
Participants take 2mg placebo PO QD for six weeks.
|
PER 1 Week Titration
n=3 participants at risk
Participants take 2mg perampanel PO QD for one week and 4mg perampanel PO QD for five weeks.
|
PER 2 Week Titration
n=6 participants at risk
Participants take 2mg perampanel PO QD for two weeks and 4mg perampanel PO QD for four weeks.
|
PER 4 mg
n=8 participants at risk
Participants take 4mg perampanel PO QD for six weeks
|
|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cyst in Nose
|
0.00%
0/2 • Up to 8 weeks.
|
0.00%
0/3 • Up to 8 weeks.
|
0.00%
0/6 • Up to 8 weeks.
|
12.5%
1/8 • Number of events 1 • Up to 8 weeks.
|
|
Nervous system disorders
Difficulty with concentration and word finding
|
0.00%
0/2 • Up to 8 weeks.
|
0.00%
0/3 • Up to 8 weeks.
|
0.00%
0/6 • Up to 8 weeks.
|
12.5%
1/8 • Number of events 1 • Up to 8 weeks.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/2 • Up to 8 weeks.
|
33.3%
1/3 • Number of events 1 • Up to 8 weeks.
|
50.0%
3/6 • Number of events 3 • Up to 8 weeks.
|
0.00%
0/8 • Up to 8 weeks.
|
|
Nervous system disorders
Fatigue
|
0.00%
0/2 • Up to 8 weeks.
|
0.00%
0/3 • Up to 8 weeks.
|
50.0%
3/6 • Number of events 3 • Up to 8 weeks.
|
50.0%
4/8 • Number of events 5 • Up to 8 weeks.
|
|
Nervous system disorders
Headache
|
0.00%
0/2 • Up to 8 weeks.
|
66.7%
2/3 • Number of events 2 • Up to 8 weeks.
|
16.7%
1/6 • Number of events 1 • Up to 8 weeks.
|
12.5%
1/8 • Number of events 1 • Up to 8 weeks.
|
|
General disorders
Fall
|
0.00%
0/2 • Up to 8 weeks.
|
0.00%
0/3 • Up to 8 weeks.
|
16.7%
1/6 • Number of events 1 • Up to 8 weeks.
|
12.5%
1/8 • Number of events 1 • Up to 8 weeks.
|
|
Nervous system disorders
Problems with coordination
|
0.00%
0/2 • Up to 8 weeks.
|
0.00%
0/3 • Up to 8 weeks.
|
16.7%
1/6 • Number of events 1 • Up to 8 weeks.
|
0.00%
0/8 • Up to 8 weeks.
|
|
Nervous system disorders
Balance Problems/Unsteadiness
|
0.00%
0/2 • Up to 8 weeks.
|
33.3%
1/3 • Number of events 1 • Up to 8 weeks.
|
0.00%
0/6 • Up to 8 weeks.
|
12.5%
1/8 • Number of events 1 • Up to 8 weeks.
|
|
Nervous system disorders
Irritability
|
0.00%
0/2 • Up to 8 weeks.
|
0.00%
0/3 • Up to 8 weeks.
|
0.00%
0/6 • Up to 8 weeks.
|
12.5%
1/8 • Number of events 1 • Up to 8 weeks.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/2 • Up to 8 weeks.
|
0.00%
0/3 • Up to 8 weeks.
|
0.00%
0/6 • Up to 8 weeks.
|
12.5%
1/8 • Number of events 1 • Up to 8 weeks.
|
|
Nervous system disorders
Lip Cramping/Twitching
|
0.00%
0/2 • Up to 8 weeks.
|
0.00%
0/3 • Up to 8 weeks.
|
16.7%
1/6 • Number of events 1 • Up to 8 weeks.
|
0.00%
0/8 • Up to 8 weeks.
|
|
General disorders
Sore Throat
|
0.00%
0/2 • Up to 8 weeks.
|
0.00%
0/3 • Up to 8 weeks.
|
16.7%
1/6 • Number of events 1 • Up to 8 weeks.
|
0.00%
0/8 • Up to 8 weeks.
|
|
General disorders
Fever
|
0.00%
0/2 • Up to 8 weeks.
|
0.00%
0/3 • Up to 8 weeks.
|
16.7%
1/6 • Number of events 1 • Up to 8 weeks.
|
0.00%
0/8 • Up to 8 weeks.
|
|
Skin and subcutaneous tissue disorders
Hair Thinning
|
0.00%
0/2 • Up to 8 weeks.
|
0.00%
0/3 • Up to 8 weeks.
|
0.00%
0/6 • Up to 8 weeks.
|
12.5%
1/8 • Number of events 1 • Up to 8 weeks.
|
|
General disorders
Leg Abrasion
|
0.00%
0/2 • Up to 8 weeks.
|
0.00%
0/3 • Up to 8 weeks.
|
0.00%
0/6 • Up to 8 weeks.
|
12.5%
1/8 • Number of events 1 • Up to 8 weeks.
|
|
Nervous system disorders
Sleep Disturbance
|
50.0%
1/2 • Number of events 1 • Up to 8 weeks.
|
33.3%
1/3 • Number of events 1 • Up to 8 weeks.
|
0.00%
0/6 • Up to 8 weeks.
|
0.00%
0/8 • Up to 8 weeks.
|
|
General disorders
Hypertension
|
50.0%
1/2 • Number of events 1 • Up to 8 weeks.
|
0.00%
0/3 • Up to 8 weeks.
|
0.00%
0/6 • Up to 8 weeks.
|
0.00%
0/8 • Up to 8 weeks.
|
|
General disorders
Loss of muscle definition/fat distribution
|
50.0%
1/2 • Number of events 1 • Up to 8 weeks.
|
0.00%
0/3 • Up to 8 weeks.
|
0.00%
0/6 • Up to 8 weeks.
|
0.00%
0/8 • Up to 8 weeks.
|
|
Blood and lymphatic system disorders
Low White Blood Cell Count
|
50.0%
1/2 • Number of events 1 • Up to 8 weeks.
|
0.00%
0/3 • Up to 8 weeks.
|
0.00%
0/6 • Up to 8 weeks.
|
0.00%
0/8 • Up to 8 weeks.
|
|
General disorders
Low glucose level
|
50.0%
1/2 • Number of events 1 • Up to 8 weeks.
|
0.00%
0/3 • Up to 8 weeks.
|
0.00%
0/6 • Up to 8 weeks.
|
0.00%
0/8 • Up to 8 weeks.
|
|
Nervous system disorders
Cognitive Change: Slowing
|
0.00%
0/2 • Up to 8 weeks.
|
33.3%
1/3 • Number of events 1 • Up to 8 weeks.
|
0.00%
0/6 • Up to 8 weeks.
|
0.00%
0/8 • Up to 8 weeks.
|
|
General disorders
Weight Gain
|
0.00%
0/2 • Up to 8 weeks.
|
66.7%
2/3 • Number of events 2 • Up to 8 weeks.
|
0.00%
0/6 • Up to 8 weeks.
|
0.00%
0/8 • Up to 8 weeks.
|
|
Infections and infestations
COVID-19 Infection
|
0.00%
0/2 • Up to 8 weeks.
|
33.3%
1/3 • Number of events 1 • Up to 8 weeks.
|
16.7%
1/6 • Number of events 1 • Up to 8 weeks.
|
0.00%
0/8 • Up to 8 weeks.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/2 • Up to 8 weeks.
|
33.3%
1/3 • Number of events 1 • Up to 8 weeks.
|
0.00%
0/6 • Up to 8 weeks.
|
0.00%
0/8 • Up to 8 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place