Trial Outcomes & Findings for Brexpiprazole for Bipolar Depression (NCT NCT03427892)
NCT ID: NCT03427892
Last Updated: 2019-03-13
Results Overview
The Montgomery-Asberg Depression Rating Scale is used to assess depressive symptom severity. There are 10 items and each item is rated from 0 to 6 (increasing severity) based on the assessment of symptoms within the past 7 days. Scoring is assisted by descriptive anchors that serve as useful guides at 0,2,4, 8. Odd numbers (1,3,5) between the descriptive anchors are also meant to be scored. Highest possible MADRS score is 60. Lowest possible MADRS score is 0. MADRS is scored by taking the sum of the scores for each item. A higher score is indicative of more acute depressive symptoms.
COMPLETED
PHASE4
21 participants
Baseline through week 8
2019-03-13
Participant Flow
This study enrolled patients recruited through flyers and other forms of advertisement. Patients met DSM-5 criteria for bipolar I or II disorder, with a current moderate to severe depressed mood state. The last patient completed on March 15, 2018.
Of the 30 patients consented and screened during the duration of the study between March 2017 and December 2017, 9 screen failed and 21 were enrolled within the study. The study was non-randomized and all patients received the same study condition.
Participant milestones
| Measure |
Brexpiprazole
Brexipiprazole will be taken orally beginning at 0.5 mg/day with an increase to 1 mg/day at week 1 and 2 mg/day at week 2. If reduction in mood symptoms does not occur, the dose will increase to 3 mg/day and 4 mg/day.
Brexpiprazole: Brexpiprazole is an atypical antipsychotic drug that is used to treat mental/mood disorders.
|
|---|---|
|
Overall Study
STARTED
|
21
|
|
Overall Study
COMPLETED
|
19
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Brexpiprazole
Brexipiprazole will be taken orally beginning at 0.5 mg/day with an increase to 1 mg/day at week 1 and 2 mg/day at week 2. If reduction in mood symptoms does not occur, the dose will increase to 3 mg/day and 4 mg/day.
Brexpiprazole: Brexpiprazole is an atypical antipsychotic drug that is used to treat mental/mood disorders.
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|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
Baseline Characteristics
Brexpiprazole for Bipolar Depression
Baseline characteristics by cohort
| Measure |
Brexpiprazole
n=19 Participants
Brexipiprazole will be taken orally beginning at 0.5 mg/day with an increase to 1 mg/day at week 1 and 2 mg/day at week 2. If reduction in mood symptoms does not occur, the dose will increase to 3 mg/day and 4 mg/day.
Brexpiprazole: Brexpiprazole is an atypical antipsychotic drug that is used to treat mental/mood disorders.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
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0 Participants
n=5 Participants
|
|
Age, Continuous
|
38.74 years
STANDARD_DEVIATION 12.38 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
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19 Participants
n=5 Participants
|
|
Montgomery Asberg Depression Rating Scale (MADRS) score ranges from 0-60, higher score is indicative
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31.95 units on a scale
STANDARD_DEVIATION 10.33 • n=5 Participants
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PRIMARY outcome
Timeframe: Baseline through week 8The Montgomery-Asberg Depression Rating Scale is used to assess depressive symptom severity. There are 10 items and each item is rated from 0 to 6 (increasing severity) based on the assessment of symptoms within the past 7 days. Scoring is assisted by descriptive anchors that serve as useful guides at 0,2,4, 8. Odd numbers (1,3,5) between the descriptive anchors are also meant to be scored. Highest possible MADRS score is 60. Lowest possible MADRS score is 0. MADRS is scored by taking the sum of the scores for each item. A higher score is indicative of more acute depressive symptoms.
Outcome measures
| Measure |
Brexpiprazole
n=19 Participants
Brexipiprazole will be taken orally beginning at 0.5 mg/day with an increase to 1 mg/day at week 1 and 2 mg/day at week 2. If reduction in mood symptoms does not occur, the dose will increase to 3 mg/day and 4 mg/day.
Brexpiprazole: Brexpiprazole is an atypical antipsychotic drug that is used to treat mental/mood disorders.
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|---|---|
|
The Montgomery-Asberg Depression Rating Scale (MADRS)
MADRS Baseline
|
31.95 score on a scale
Standard Deviation 10.33
|
|
The Montgomery-Asberg Depression Rating Scale (MADRS)
MADRS Week 4
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9.95 score on a scale
Standard Deviation 8.28
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The Montgomery-Asberg Depression Rating Scale (MADRS)
MADRS Week 8
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10.95 score on a scale
Standard Deviation 9.59
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SECONDARY outcome
Timeframe: Baseline through week 8Young Mania Rating Scale is an observer-rated measure of mania symptoms. It has 11 items and each items has 5 defined anchor points with increasing severity that describe the symptom characteristics. YMRS is scored by taking sum of the scores for the 11 items. A higher score indicative of more acute manic symptoms. Seven of the items are scored between 0 and 4. Four items allow for scoring between anchor points (ranging 1 to 8). Maximum score is 60 and minimum score is 0.
Outcome measures
| Measure |
Brexpiprazole
n=19 Participants
Brexipiprazole will be taken orally beginning at 0.5 mg/day with an increase to 1 mg/day at week 1 and 2 mg/day at week 2. If reduction in mood symptoms does not occur, the dose will increase to 3 mg/day and 4 mg/day.
Brexpiprazole: Brexpiprazole is an atypical antipsychotic drug that is used to treat mental/mood disorders.
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|---|---|
|
Young Mania Rating Scale (YMRS)
YMRS Baseline
|
4.63 score on a scale
Standard Deviation 3.22
|
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Young Mania Rating Scale (YMRS)
YMRS Week 4
|
4.21 score on a scale
Standard Deviation 3.97
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Young Mania Rating Scale (YMRS)
YMRS Week 8
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4.42 score on a scale
Standard Deviation 5.36
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SECONDARY outcome
Timeframe: Baseline through week 8Rey Auditory Verbal Learning Test (RAVLT) is a test of verbal learning and declarative memory. During the test, 15 nouns that are read aloud for 5 consecutive trials. Each trial is followed by a free recall test (participant is asked to recall the words that were just read to them). The sum of correctly recalled words across 5 trials is called the total raw score. On completion of Trial 5, an interference list of 15 words (List B) is presented, followed by a free recall test of that list. After a 20-min delay, the examinee is again required to recall the words from list A - this is called the delay raw score. The raw scores on both the total recall and the delay trials (number of words correct across trials 1-5) are converted to standardized T-scores (Mean=50; SD=10; range 20-100) based on participant age and gender. The scores below are presented as T-scores, with higher scores indicative of better performance.
Outcome measures
| Measure |
Brexpiprazole
n=19 Participants
Brexipiprazole will be taken orally beginning at 0.5 mg/day with an increase to 1 mg/day at week 1 and 2 mg/day at week 2. If reduction in mood symptoms does not occur, the dose will increase to 3 mg/day and 4 mg/day.
Brexpiprazole: Brexpiprazole is an atypical antipsychotic drug that is used to treat mental/mood disorders.
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|---|---|
|
Rey Auditoy Verbal Learning Test
RAVLT T Score Baseline
|
37.47 T-scores
Standard Deviation 16.67
|
|
Rey Auditoy Verbal Learning Test
RAVLT T Score Week 4
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37.79 T-scores
Standard Deviation 10.36
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Rey Auditoy Verbal Learning Test
RAVLT T Score Week 8
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40.42 T-scores
Standard Deviation 11.97
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Rey Auditoy Verbal Learning Test
RAVLT Delay Baseline
|
39.74 T-scores
Standard Deviation 13.23
|
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Rey Auditoy Verbal Learning Test
RAVLT Delay Week 4
|
37.00 T-scores
Standard Deviation 9.010
|
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Rey Auditoy Verbal Learning Test
RAVLT Delay Week 8
|
39.26 T-scores
Standard Deviation 13.14
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SECONDARY outcome
Timeframe: Baseline through week 8The Stroop task evaluates attention, speed, and accuracy of thinking. Stroop task consists of three separate trials: word, color, and color-word (CW) naming. For each trial, a raw score (correct number of words named) is recorded. The raw score for each trial is converted to a T-score based on participant's age and education level. The possible T-scores range from 15-85 for the word trial, 8-92 for the color trial, and 3-98 for the color-word trial. The interference score (Inter) is also derived from the color-word score, with T-scores ranging from 21-80. Higher numbers indicate better performance. The entered values represent T-scores.
Outcome measures
| Measure |
Brexpiprazole
n=19 Participants
Brexipiprazole will be taken orally beginning at 0.5 mg/day with an increase to 1 mg/day at week 1 and 2 mg/day at week 2. If reduction in mood symptoms does not occur, the dose will increase to 3 mg/day and 4 mg/day.
Brexpiprazole: Brexpiprazole is an atypical antipsychotic drug that is used to treat mental/mood disorders.
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|---|---|
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Stroop Task
STROOP-CW Baseline
|
48.11 T-scores
Standard Deviation 7.39
|
|
Stroop Task
STROOP-CW Week 4
|
41.21 T-scores
Standard Deviation 34.73
|
|
Stroop Task
STROOP-CW Week 8
|
50.74 T-scores
Standard Deviation 6.82
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|
Stroop Task
STROOP-Inter Baseline
|
49.89 T-scores
Standard Deviation 5.64
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|
Stroop Task
STROOP-Inter Week 4
|
43.47 T-scores
Standard Deviation 34.95
|
|
Stroop Task
STROOP-Inter Week 8
|
51.79 T-scores
Standard Deviation 5.06
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SECONDARY outcome
Timeframe: Baseline through week 8The Trail Making Test (TMT) measures attention, speed, and accuracy. TMT consists of two parts: Trails A and Trails B. The performance on each test is measured in seconds and represents how quickly a participant can connect the numbers (Trails A) and the numbers and letters (Trails B) together. The number of seconds it takes to complete each part of TMT is converted to a T-score based on gender, age, race, and education. The T-scores range from 0-100 with higher scores indicating better (faster) performance. The entered data are presented as T-Scores.
Outcome measures
| Measure |
Brexpiprazole
n=19 Participants
Brexipiprazole will be taken orally beginning at 0.5 mg/day with an increase to 1 mg/day at week 1 and 2 mg/day at week 2. If reduction in mood symptoms does not occur, the dose will increase to 3 mg/day and 4 mg/day.
Brexpiprazole: Brexpiprazole is an atypical antipsychotic drug that is used to treat mental/mood disorders.
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|---|---|
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Trail Making Test (TMT)
TMT B Score Week 8
|
49.68 T-scores
Standard Deviation 11.48
|
|
Trail Making Test (TMT)
TMT A Score Week 8
|
53.47 T-scores
Standard Deviation 13.24
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|
Trail Making Test (TMT)
TMT B Score Baseline
|
45.79 T-scores
Standard Deviation 6.39
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|
Trail Making Test (TMT)
TMT B Score Week 4
|
47.37 T-scores
Standard Deviation 7.57
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|
Trail Making Test (TMT)
TMT A Score Baseline
|
47.74 T-scores
Standard Deviation 9.34
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|
Trail Making Test (TMT)
TMT A Score Week 4
|
51.16 T-scores
Standard Deviation 11.49
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SECONDARY outcome
Timeframe: Baseline through week 8The Systematic Assessment for Treatment Emergent Effects (SAFTEE) is a self-report scale used in clinical trials and is designed to evaluate the degree to which each possible side effect is bothersome to a participant. There are 55 items on the scale (each item represents a different side effect), with each item rated on a 4-point scale such as "not bothersome - 0 (zero)", "mildly bothersome - 1", "moderately bothersome - 2", "severely bothersome - 3". The total possible range of scores on the scale is 0-165. The higher scores indicate a higher degree of being bothered by various side effects.
Outcome measures
| Measure |
Brexpiprazole
n=19 Participants
Brexipiprazole will be taken orally beginning at 0.5 mg/day with an increase to 1 mg/day at week 1 and 2 mg/day at week 2. If reduction in mood symptoms does not occur, the dose will increase to 3 mg/day and 4 mg/day.
Brexpiprazole: Brexpiprazole is an atypical antipsychotic drug that is used to treat mental/mood disorders.
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|---|---|
|
Systematic Assessment For Treatment Emergent Events
SAFTEE Baseline
|
49.79 score on a scale
Standard Deviation 27.74
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Systematic Assessment For Treatment Emergent Events
SAFTEE Week 4
|
23.53 score on a scale
Standard Deviation 20.51
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|
Systematic Assessment For Treatment Emergent Events
SAFTEE Week 8
|
23.42 score on a scale
Standard Deviation 22.24
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SECONDARY outcome
Timeframe: Baseline through week 8The Columbia Suicide Severity Rating Scale (C-SSRS) is a structured interview and rating scale used to measure suicidal thoughts and behaviors. Actual attempts, interrupted attempts, and aborted attempts are measured as positive integers (zero and above). The minimum value for the actual, interrupted, and aborted attempt is zero (reflecting no past suicidal behavior). There is no maximum scale value, as the number of attempts differs for each participant. The entered values represent the average number of actual, interrupted, and aborted attempts in the group. Higher values reflect a higher number of attempts experienced by each participant (equivalent to a worse outcome).
Outcome measures
| Measure |
Brexpiprazole
n=19 Participants
Brexipiprazole will be taken orally beginning at 0.5 mg/day with an increase to 1 mg/day at week 1 and 2 mg/day at week 2. If reduction in mood symptoms does not occur, the dose will increase to 3 mg/day and 4 mg/day.
Brexpiprazole: Brexpiprazole is an atypical antipsychotic drug that is used to treat mental/mood disorders.
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|---|---|
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Columbia Suicide Severity Rating Scale
C-SSRS Actual Attempts -in lifetime- Baseline
|
1.35 attempts
Standard Deviation 2.43
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Columbia Suicide Severity Rating Scale
C-SSRS Actual Attempts-since last visit Week 4
|
0.00 attempts
Standard Deviation 0.00
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Columbia Suicide Severity Rating Scale
C-SSRS Actual Attempts-since last visit Week 8
|
0.00 attempts
Standard Deviation 0.00
|
|
Columbia Suicide Severity Rating Scale
C-SSRS Interrupted Attempts-in lifetime- Baseline
|
0.10 attempts
Standard Deviation 0.31
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|
Columbia Suicide Severity Rating Scale
CSSRS Interrupted Attempts-since last visit Week 4
|
0.00 attempts
Standard Deviation 0.00
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Columbia Suicide Severity Rating Scale
CSSRS Interrupted Attempts-since last visit Week 8
|
0.00 attempts
Standard Deviation 0.00
|
|
Columbia Suicide Severity Rating Scale
C-SSRS Aborted Attempt-in lifetime-Baseline
|
0.00 attempts
Standard Deviation 0.00
|
|
Columbia Suicide Severity Rating Scale
C-SSRS Aborted Attempt-since last visit-Week 4
|
0.00 attempts
Standard Deviation 0.00
|
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Columbia Suicide Severity Rating Scale
C-SSRS Aborted Attempt-since last visit-Week 8
|
0.00 attempts
Standard Deviation 0.00
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SECONDARY outcome
Timeframe: Baseline through week 8The Abnormal Involuntary Movement Scale (AIMS) is an assessment of movements to determine any long-term drug induced movement disorders.There are 10 items on the scale with scores ranging from 0-4 (0 None/Normal, 1 minimal, 2 mild, 3 moderate,4 severe). 4 items assess facial and oral movements, 2 items measure extremity movements, 1 item measures trunk movements, and 3 items measure global judgments regarding symptoms assessed. A total score is the sum of scores for items assessing facial and oral movements, extremity movements, and trunk movement (scores ranging from 0-28), with 0 being the lowest score, and 28 being the highest score. A higher score is indicative of a higher severity in symptomatology.
Outcome measures
| Measure |
Brexpiprazole
n=19 Participants
Brexipiprazole will be taken orally beginning at 0.5 mg/day with an increase to 1 mg/day at week 1 and 2 mg/day at week 2. If reduction in mood symptoms does not occur, the dose will increase to 3 mg/day and 4 mg/day.
Brexpiprazole: Brexpiprazole is an atypical antipsychotic drug that is used to treat mental/mood disorders.
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|---|---|
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Abnormal Involuntary Movement Scale
AIMS Baseline
|
0.63 score on a scale
Standard Deviation 2.09
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Abnormal Involuntary Movement Scale
AIMS Week 4
|
1.26 score on a scale
Standard Deviation 2.23
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Abnormal Involuntary Movement Scale
AIMS Week 8
|
1.16 score on a scale
Standard Deviation 2.29
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SECONDARY outcome
Timeframe: Baseline through week 8The Barnes Akathisia Scale (BAS) is an assessment of movements to determine any short-term drug-induced movement disorders. There are 5 items.Items 1-3 are rated from a scale of 0-3 with 0 indicating the least severity, and 3 indicating the highest severity of symptoms. Item 4 is a global assessment of symptoms assessed and the severity is assessed on a scale of 0-5, with 0 indication least severity and 5 indicating the most severity.The total score is the sum of all the item scores (scores ranging from 0-14).With higher scores reflecting worse outcome.
Outcome measures
| Measure |
Brexpiprazole
n=19 Participants
Brexipiprazole will be taken orally beginning at 0.5 mg/day with an increase to 1 mg/day at week 1 and 2 mg/day at week 2. If reduction in mood symptoms does not occur, the dose will increase to 3 mg/day and 4 mg/day.
Brexpiprazole: Brexpiprazole is an atypical antipsychotic drug that is used to treat mental/mood disorders.
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|---|---|
|
Barnes Akathisia Scale
BAS Baseline
|
0.12 score on a scale
Standard Deviation 0.12
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Barnes Akathisia Scale
BAS Week 4
|
2.37 score on a scale
Standard Deviation 0.56
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Barnes Akathisia Scale
BAS Week 8
|
2.47 score on a scale
Standard Deviation 0.57
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SECONDARY outcome
Timeframe: Baseline through week 8The Simpson Angus Scale (SAS) measured drug-induced movement side effects. There are 10 items on the scale, with each item scored on a scale of 0-4 (least to most severe). The total possible range of scores across all items is 0-40, with higher scores indicative of worse outcome.
Outcome measures
| Measure |
Brexpiprazole
n=19 Participants
Brexipiprazole will be taken orally beginning at 0.5 mg/day with an increase to 1 mg/day at week 1 and 2 mg/day at week 2. If reduction in mood symptoms does not occur, the dose will increase to 3 mg/day and 4 mg/day.
Brexpiprazole: Brexpiprazole is an atypical antipsychotic drug that is used to treat mental/mood disorders.
|
|---|---|
|
Simpson Angus Scale
SAS Baseline
|
0.37 score on a scale
Standard Deviation 0.23
|
|
Simpson Angus Scale
SAS Week 4
|
1.16 score on a scale
Standard Deviation 0.34
|
|
Simpson Angus Scale
SAS Week 8
|
1.00 score on a scale
Standard Deviation 0.32
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SECONDARY outcome
Timeframe: Baseline and at week 8The Quality Of Life in Bipolar Disorder (QOLBD) is a measure of the quality of life in patients with bipolar disorder. All questions on the scale ask about a range of experiences, behaviors, and feeling related to the quality of life. For each question, a participant is asked to indicate how much they agree with each question. The scale consists of 12 questions, with each question measured on a 5-point scale, such as "strongly disagree - 1", "disagree - 2", "neutral - 3", "agree - 4", "strongly agree - 5". The total possible range of scores on the scale is 12-60. Higher scores indicate better quality of life.
Outcome measures
| Measure |
Brexpiprazole
n=19 Participants
Brexipiprazole will be taken orally beginning at 0.5 mg/day with an increase to 1 mg/day at week 1 and 2 mg/day at week 2. If reduction in mood symptoms does not occur, the dose will increase to 3 mg/day and 4 mg/day.
Brexpiprazole: Brexpiprazole is an atypical antipsychotic drug that is used to treat mental/mood disorders.
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|---|---|
|
Quality of Life in Bipolar Disorder (QOLBD)
QOLBD baseline
|
30.38 score on a scale
Standard Deviation 8.97
|
|
Quality of Life in Bipolar Disorder (QOLBD)
QOLBD Week 8
|
40.95 score on a scale
Standard Deviation 11.03
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SECONDARY outcome
Timeframe: Baseline through week 8An 30 item inventory self report assessing depressive symptoms and mood, within the past seven days. With the score range of 0-90 with higher scores indicating worse outcome.
Outcome measures
| Measure |
Brexpiprazole
n=19 Participants
Brexipiprazole will be taken orally beginning at 0.5 mg/day with an increase to 1 mg/day at week 1 and 2 mg/day at week 2. If reduction in mood symptoms does not occur, the dose will increase to 3 mg/day and 4 mg/day.
Brexpiprazole: Brexpiprazole is an atypical antipsychotic drug that is used to treat mental/mood disorders.
|
|---|---|
|
The Inventory of Depressive Symptomatology Self-Report (IDS-SR30)
IDS-SR30 Baseline
|
41.63 score on a scale
Standard Deviation 17.50
|
|
The Inventory of Depressive Symptomatology Self-Report (IDS-SR30)
IDS-SR30 Week 4
|
18.95 score on a scale
Standard Deviation 12.95
|
|
The Inventory of Depressive Symptomatology Self-Report (IDS-SR30)
IDS-SR30 Week 8
|
17.89 score on a scale
Standard Deviation 16.19
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and at week 8high sensitivity C-Reactive Protein values will be used to measure inflammation
Outcome measures
| Measure |
Brexpiprazole
n=19 Participants
Brexipiprazole will be taken orally beginning at 0.5 mg/day with an increase to 1 mg/day at week 1 and 2 mg/day at week 2. If reduction in mood symptoms does not occur, the dose will increase to 3 mg/day and 4 mg/day.
Brexpiprazole: Brexpiprazole is an atypical antipsychotic drug that is used to treat mental/mood disorders.
|
|---|---|
|
High Sensitivity C-Reactive Protein (Hs-CRP)
hs-CRP Baseline
|
3.56 mg/L
Standard Deviation 8.61
|
|
High Sensitivity C-Reactive Protein (Hs-CRP)
hs-CRP Week 8
|
3.72 mg/L
Standard Deviation 9.56
|
Adverse Events
Brexpiprazole
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Brexpiprazole
n=19 participants at risk
Brexipiprazole will be taken orally beginning at 0.5 mg/day with an increase to 1 mg/day at week 1 and 2 mg/day at week 2. If reduction in mood symptoms does not occur, the dose will increase to 3 mg/day and 4 mg/day.
Brexpiprazole: Brexpiprazole is an atypical antipsychotic drug that is used to treat mental/mood disorders.
|
|---|---|
|
Nervous system disorders
Restlessness
|
10.5%
2/19 • Number of events 2 • 8 weeks
|
|
Eye disorders
Eye twitch
|
10.5%
2/19 • Number of events 2 • 8 weeks
|
|
Nervous system disorders
Dizziness
|
10.5%
2/19 • Number of events 2 • 8 weeks
|
|
Musculoskeletal and connective tissue disorders
Jaw clenching
|
5.3%
1/19 • Number of events 1 • 8 weeks
|
|
Metabolism and nutrition disorders
Weight Gain
|
5.3%
1/19 • Number of events 1 • 8 weeks
|
|
Nervous system disorders
Migraines
|
5.3%
1/19 • Number of events 1 • 8 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place