Trial Outcomes & Findings for Preliminary Trial of the Effect of Glucocorticoid Receptor Antagonist on Borderline Personality Disorder (BPD) (NCT NCT01212588)
NCT ID: NCT01212588
Last Updated: 2019-02-26
Results Overview
To evaluate whether mifepristone will produce rapid symptom change after seven days of active treatment, as measured by Borderline Personality Disorder Severity Index (BPDSI) total score. The BPDSI is a semi-structured clinical interview assessing the frequency and severity of manifestations of Borderline Personality Disorder (BPD) during a circumscribed period of the previous 7 days. The BPDSI measures 9 symptoms associated with BPD on a Likert scale ranging from 0-7 (0 = never; 7 = daily). Each symptom measure produces a mean score ranging from 0-7, with a higher score indicating more prevalent symptoms. A total score is then calculated using the summed symptom mean scores, ranging from 0-63, with a higher score indicating more prevalent symptoms.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
22 participants
Primary outcome timeframe
Baseline to 7 days of study medication
Results posted on
2019-02-26
Participant Flow
Participant milestones
| Measure |
Mifepristone
Mifepristone 600mg once daily x 7 days
mifepristone: Mifepristone 600mg (3x200mg tablets) once daily for seven days
|
Placebo
Matching placebo tablets one daily
Placebo: 3 tablets once daily for seven days
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
12
|
|
Overall Study
COMPLETED
|
9
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Mifepristone
Mifepristone 600mg once daily x 7 days
mifepristone: Mifepristone 600mg (3x200mg tablets) once daily for seven days
|
Placebo
Matching placebo tablets one daily
Placebo: 3 tablets once daily for seven days
|
|---|---|---|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Protocol Violation
|
1
|
1
|
Baseline Characteristics
Preliminary Trial of the Effect of Glucocorticoid Receptor Antagonist on Borderline Personality Disorder (BPD)
Baseline characteristics by cohort
| Measure |
Mifepristone
n=10 Participants
Mifepristone 600mg once daily x 7 days
mifepristone: Mifepristone 600mg (3x200mg tablets) once daily for seven days
|
Placebo
n=12 Participants
Matching placebo tablets one daily
Placebo: 3 tablets once daily for seven days
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
40.90 years
STANDARD_DEVIATION 11.75 • n=5 Participants
|
33.42 years
STANDARD_DEVIATION 10.33 • n=7 Participants
|
36.82 years
STANDARD_DEVIATION 11.39 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
12 participants
n=7 Participants
|
22 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 7 days of study medicationTo evaluate whether mifepristone will produce rapid symptom change after seven days of active treatment, as measured by Borderline Personality Disorder Severity Index (BPDSI) total score. The BPDSI is a semi-structured clinical interview assessing the frequency and severity of manifestations of Borderline Personality Disorder (BPD) during a circumscribed period of the previous 7 days. The BPDSI measures 9 symptoms associated with BPD on a Likert scale ranging from 0-7 (0 = never; 7 = daily). Each symptom measure produces a mean score ranging from 0-7, with a higher score indicating more prevalent symptoms. A total score is then calculated using the summed symptom mean scores, ranging from 0-63, with a higher score indicating more prevalent symptoms.
Outcome measures
| Measure |
Mifepristone
n=10 Participants
Mifepristone 600mg once daily x 7 days
mifepristone: Mifepristone 600mg (3x200mg tablets) once daily for seven days
|
Placebo
n=12 Participants
Matching placebo tablets one daily
Placebo: 3 tablets once daily for seven days
|
|---|---|---|
|
Rapid Symptom Change
BPDSI Total Score after 7 days of medication
|
13.5 Scores on a scale
Standard Deviation 7.93
|
9.45 Scores on a scale
Standard Deviation 4.24
|
|
Rapid Symptom Change
BPDSI Total Score at Baseline
|
17.99 Scores on a scale
Standard Deviation 6.65
|
13.66 Scores on a scale
Standard Deviation 7.72
|
PRIMARY outcome
Timeframe: 7 days of study medication to 21 days after discontinuation of study medicationTo evaluate whether seven days of mifepristone treatment will result in a durable change in symptoms persisting after active treatment discontinuation, as measured by Borderline Personality Disorder Severity Index (BPDSI) total score. The BPDSI is a semi-structured clinical interview assessing the frequency and severity of manifestations of Borderline Personality Disorder (BPD) during a circumscribed period of the previous 7 days. The BPDSI measures 9 symptoms associated with BPD on a Likert scale ranging from 0-7 (0 = never; 7 = daily). Each symptom measure produces a mean score ranging from 0-7, with a higher score indicating more prevalent symptoms. A total score is then calculated using the summed symptom mean scores, ranging from 0-63, with a higher score indicating more prevalent symptoms.
Outcome measures
| Measure |
Mifepristone
n=10 Participants
Mifepristone 600mg once daily x 7 days
mifepristone: Mifepristone 600mg (3x200mg tablets) once daily for seven days
|
Placebo
n=12 Participants
Matching placebo tablets one daily
Placebo: 3 tablets once daily for seven days
|
|---|---|---|
|
Durable Symptom Change
BPDSI Total Score after 7 days of medication
|
13.50 Scores on a scale
Standard Deviation 7.93
|
9.45 Scores on a scale
Standard Deviation 4.24
|
|
Durable Symptom Change
BPDSI Total Score 21 days after discont. study med
|
13.58 Scores on a scale
Standard Deviation 5.31
|
8.17 Scores on a scale
Standard Deviation 4.32
|
PRIMARY outcome
Timeframe: Baseline to 21 days after discontinuation of study medicationTo determine the safety and tolerability of mifepristone according to subject report of possibly and probably related adverse events (AEs). AEs were evaluated by study physicians at each visit and each reported AE was evaluated for relatedness (unrelated, possibly related, or probably related) to the study drug/procedure.
Outcome measures
| Measure |
Mifepristone
n=10 Participants
Mifepristone 600mg once daily x 7 days
mifepristone: Mifepristone 600mg (3x200mg tablets) once daily for seven days
|
Placebo
n=12 Participants
Matching placebo tablets one daily
Placebo: 3 tablets once daily for seven days
|
|---|---|---|
|
Number of Participants With Possibly and Probably Related Adverse Events
Number of subjects with possibly related AEs
|
9 Participants
|
6 Participants
|
|
Number of Participants With Possibly and Probably Related Adverse Events
Number of subjects with probably related AEs
|
3 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Baseline (Visit 2), 7 days of study medication (Visit 4), 7 days after discontinuation of study medication (Visit 5), 21 days after discontinuation of study medication (Visit 6)To assess cortisol levels as a potential biomarker of hypothalamic-pituitary-adrenal (HPA)-axis engagement
Outcome measures
| Measure |
Mifepristone
n=10 Participants
Mifepristone 600mg once daily x 7 days
mifepristone: Mifepristone 600mg (3x200mg tablets) once daily for seven days
|
Placebo
n=12 Participants
Matching placebo tablets one daily
Placebo: 3 tablets once daily for seven days
|
|---|---|---|
|
Levels of Cortisol
Cortisol Level - Baseline
|
13.88 mcg/dL
Standard Deviation 5.39
|
14.38 mcg/dL
Standard Deviation 8.58
|
|
Levels of Cortisol
Cortisol Level - 7 days of study med
|
35.01 mcg/dL
Standard Deviation 17.41
|
16.33 mcg/dL
Standard Deviation 9.50
|
|
Levels of Cortisol
Cortisol Level - 7 days after disc of study med
|
20.91 mcg/dL
Standard Deviation 5.53
|
14.30 mcg/dL
Standard Deviation 6.88
|
|
Levels of Cortisol
Cortisol Level - 21 days after disc study med
|
11.90 mcg/dL
Standard Deviation 4.95
|
15.73 mcg/dL
Standard Deviation 12.00
|
SECONDARY outcome
Timeframe: Baseline (Visit 2)Borderline Personality Disorder Severity Index (BPDSI) symptom domain subscales scores. The BPDSI is a semi-structured clinical interview assessing the frequency and severity of manifestations of Borderline Personality Disorder (BPD) during a circumscribed period of the previous 7 days. The BPDSI measures 9 symptoms associated with BPD on a Likert scale ranging from 0-7 (0 = never; 7 = daily). Each symptom measure produces a mean score ranging from 0-7, with a higher score indicating more prevalent symptoms.
Outcome measures
| Measure |
Mifepristone
n=10 Participants
Mifepristone 600mg once daily x 7 days
mifepristone: Mifepristone 600mg (3x200mg tablets) once daily for seven days
|
Placebo
n=12 Participants
Matching placebo tablets one daily
Placebo: 3 tablets once daily for seven days
|
|---|---|---|
|
Symptom Change - BPDSI Subscales
BPDSI Subscale Score - Abandonment
|
1.46 Scores on a scale
Standard Deviation 0.96
|
1.36 Scores on a scale
Standard Deviation 1.55
|
|
Symptom Change - BPDSI Subscales
BPDSI Subscale Score - Interpersonal Relationships
|
1.34 Scores on a scale
Standard Deviation 0.91
|
0.70 Scores on a scale
Standard Deviation 0.77
|
|
Symptom Change - BPDSI Subscales
BPDSI Subscale Score - Identity
|
2.76 Scores on a scale
Standard Deviation 1.14
|
1.49 Scores on a scale
Standard Deviation 1.34
|
|
Symptom Change - BPDSI Subscales
BPDSI Subscale Score - Impulsivity
|
0.78 Scores on a scale
Standard Deviation 0.62
|
0.32 Scores on a scale
Standard Deviation 0.37
|
|
Symptom Change - BPDSI Subscales
BPDSI Subscale Score - Parasuicidal Behavior
|
0.48 Scores on a scale
Standard Deviation 0.62
|
0.30 Scores on a scale
Standard Deviation 0.46
|
|
Symptom Change - BPDSI Subscales
BPDSI Subscale Score - Affective Instability
|
4.40 Scores on a scale
Standard Deviation 1.79
|
4.48 Scores on a scale
Standard Deviation 2.41
|
|
Symptom Change - BPDSI Subscales
BPDSI Subscale Score - Emptiness
|
3.96 Scores on a scale
Standard Deviation 2.17
|
2.35 Scores on a scale
Standard Deviation 1.39
|
|
Symptom Change - BPDSI Subscales
BPDSI Subscale Score - Outbursts of Anger
|
1.45 Scores on a scale
Standard Deviation 1.27
|
1.53 Scores on a scale
Standard Deviation 2.36
|
|
Symptom Change - BPDSI Subscales
BPDSI Sub. Score-Dissociation & Paranoid Ideation
|
1.45 Scores on a scale
Standard Deviation 0.98
|
1.14 Scores on a scale
Standard Deviation 1.28
|
SECONDARY outcome
Timeframe: Baseline (Visit 2), 7 days of study medication (Visit 4), 7 days after discontinuation of study medication (Visit 5), 21 days after discontinuation of study medication (Visit 6)The Brief Psychiatric Rating Scale (BPRS) is an 19-item scale measuring positive symptoms, general psychopathology and affective symptoms during the last 7 days. The BPRS measures symptoms with scores ranging from 0-7, with a higher score indicating more severity. A total score is then calculated by adding all the item scores, ranging from 0-133, with a higher score indicating more severity.
Outcome measures
| Measure |
Mifepristone
n=10 Participants
Mifepristone 600mg once daily x 7 days
mifepristone: Mifepristone 600mg (3x200mg tablets) once daily for seven days
|
Placebo
n=12 Participants
Matching placebo tablets one daily
Placebo: 3 tablets once daily for seven days
|
|---|---|---|
|
Symptom Change - BPRS
BPRS - Baseline
|
37.70 Scores on a scale
Standard Deviation 5.85
|
37.50 Scores on a scale
Standard Deviation 7.09
|
|
Symptom Change - BPRS
BPRS - 7 days of study medication
|
33.90 Scores on a scale
Standard Deviation 6.15
|
33.36 Scores on a scale
Standard Deviation 7.30
|
|
Symptom Change - BPRS
BPRS - 7 days after disc of study med
|
35.78 Scores on a scale
Standard Deviation 6.57
|
33.50 Scores on a scale
Standard Deviation 7.66
|
|
Symptom Change - BPRS
BPRS - 21 days after disc study med
|
35.22 Scores on a scale
Standard Deviation 6.34
|
30.50 Scores on a scale
Standard Deviation 5.44
|
SECONDARY outcome
Timeframe: Baseline (Visit 2), 7 days of study medication (Visit 4), 7 days after discontinuation of study medication (Visit 5), 21 days after discontinuation of study medication (Visit 6)The Borderline Personality Checklist (BPD Checklist) is a 47-item DSM-IV based self-report questionnaire, designed to assess the experienced burden of specific BPD symptoms during the previous week. The BPD Checklist measures symptoms with scores ranging from 1-5, with a higher score indicating more severity. A total score is then calculated by adding all the item scores, ranging from 47-235, with a higher score indicating more severity.
Outcome measures
| Measure |
Mifepristone
n=10 Participants
Mifepristone 600mg once daily x 7 days
mifepristone: Mifepristone 600mg (3x200mg tablets) once daily for seven days
|
Placebo
n=12 Participants
Matching placebo tablets one daily
Placebo: 3 tablets once daily for seven days
|
|---|---|---|
|
Symptom Change - Borderline Checklist
BPD Checklist - Baseline
|
103.60 Scores on a scale
Standard Deviation 30.83
|
96.92 Scores on a scale
Standard Deviation 26.29
|
|
Symptom Change - Borderline Checklist
BPD Checklist - 7 days of study med
|
98.10 Scores on a scale
Standard Deviation 27.22
|
88.36 Scores on a scale
Standard Deviation 32.02
|
|
Symptom Change - Borderline Checklist
BPD Checklist - 7 days after disc of study med
|
91.56 Scores on a scale
Standard Deviation 26.74
|
82.80 Scores on a scale
Standard Deviation 37.94
|
|
Symptom Change - Borderline Checklist
BPD Checklist - 21 days after disc study med
|
87.89 Scores on a scale
Standard Deviation 24.31
|
78.80 Scores on a scale
Standard Deviation 28.01
|
SECONDARY outcome
Timeframe: Baseline (Visit 2)The Symptom Checklist-90-Revised (SCL-90-R) instrument helps evaluate a broad range of psychological problems and symptoms of psychopathology. The instrument is also useful in measuring patient progress or treatment outcomes. The SCL-90-R contains 90 items on a 5-point rating scale, with a higher score indicating more severity. The items are categorized into 12 domains (9 scores along primary symptom dimensions and 3 scores among global distress indices). A t-score for each domain is then obtained by norming by sex and ranges between 19-81, with a higher score indicating more severity.
Outcome measures
| Measure |
Mifepristone
n=10 Participants
Mifepristone 600mg once daily x 7 days
mifepristone: Mifepristone 600mg (3x200mg tablets) once daily for seven days
|
Placebo
n=12 Participants
Matching placebo tablets one daily
Placebo: 3 tablets once daily for seven days
|
|---|---|---|
|
Symptom Change - SCL-90-R
SCl-90-R - Somatization
|
55.80 Scores on a scale
Standard Deviation 6.18
|
50.25 Scores on a scale
Standard Deviation 9.96
|
|
Symptom Change - SCL-90-R
SCL-90-R - Obsessive-Complusive
|
56.20 Scores on a scale
Standard Deviation 8.48
|
51.50 Scores on a scale
Standard Deviation 9.04
|
|
Symptom Change - SCL-90-R
SCL-90-R - Interpersonal Sensitivity
|
56.50 Scores on a scale
Standard Deviation 12.19
|
51.58 Scores on a scale
Standard Deviation 7.55
|
|
Symptom Change - SCL-90-R
SCL-90-R - Depression
|
54.40 Scores on a scale
Standard Deviation 8.91
|
49.75 Scores on a scale
Standard Deviation 9.20
|
|
Symptom Change - SCL-90-R
SCL-90-R - Anxiety
|
52.60 Scores on a scale
Standard Deviation 9.09
|
47.17 Scores on a scale
Standard Deviation 7.72
|
|
Symptom Change - SCL-90-R
SCL-90-R - Hostility
|
53.70 Scores on a scale
Standard Deviation 8.54
|
53.00 Scores on a scale
Standard Deviation 7.60
|
|
Symptom Change - SCL-90-R
SCL-90-R - Phobic Anxiety
|
50.00 Scores on a scale
Standard Deviation 8.94
|
54.58 Scores on a scale
Standard Deviation 11.05
|
|
Symptom Change - SCL-90-R
SCL-90-R - Paranoid Ideation
|
56.40 Scores on a scale
Standard Deviation 9.75
|
48.45 Scores on a scale
Standard Deviation 7.66
|
|
Symptom Change - SCL-90-R
SCL-90-R - Psychoticism
|
52.20 Scores on a scale
Standard Deviation 9.37
|
47.67 Scores on a scale
Standard Deviation 8.55
|
|
Symptom Change - SCL-90-R
SCL-90-R - Global Severity Index
|
55.20 Scores on a scale
Standard Deviation 9.16
|
50.00 Scores on a scale
Standard Deviation 8.42
|
|
Symptom Change - SCL-90-R
SCL-90-R - Positive Symptom Total
|
55.90 Scores on a scale
Standard Deviation 10.72
|
49.00 Scores on a scale
Standard Deviation 7.95
|
|
Symptom Change - SCL-90-R
SCL-90-R - Positive Symptom Distress Index
|
54.50 Scores on a scale
Standard Deviation 7.49
|
52.25 Scores on a scale
Standard Deviation 8.92
|
SECONDARY outcome
Timeframe: Baseline, 21 days after discontinuation of study medicationPopulation: The IPII assessment was added to the study midway through the study therefore, the first 10 subjects did not have this assessments.
The Indiana Psychiatric Illness Interview (IPII) is a semi-structured interview developed to assess illness narratives. Responses are audio taped and later transcribed. It is scored using the Metacognition Assessment Scale- Abbreviated (MAS-A), which has four domains of metacognition: i) Self-Reflectivity ranging from 0-9; ii) Understanding the Mind of Other ranging from 0-7; iii) Decentration ranging from 0-3; and iv) Mastery ranging from 0-9. Lower scores indicate metacognitive deficits, higher scores indicate more integrated and nuanced metacognition. MAS-A total score is the sum of the scores on each of the domains of metacognition, ranging from 0-28, with a lower score indicating metacognitive deficits and a higher score indicating more integrated and nuanced metacognition.
Outcome measures
| Measure |
Mifepristone
n=6 Participants
Mifepristone 600mg once daily x 7 days
mifepristone: Mifepristone 600mg (3x200mg tablets) once daily for seven days
|
Placebo
n=6 Participants
Matching placebo tablets one daily
Placebo: 3 tablets once daily for seven days
|
|---|---|---|
|
Metacognitive Capacity
IIPI - Self-Reflectivity - Baseline
|
5.08 Scores on a scale
Standard Deviation 1.63
|
4.63 Scores on a scale
Standard Deviation 1.70
|
|
Metacognitive Capacity
IIPI-Self-Reflectivity-21 days after dis study med
|
5.25 Scores on a scale
Standard Deviation 1.89
|
3.90 Scores on a scale
Standard Deviation 0.42
|
|
Metacognitive Capacity
IIPI - Understanding Others - Baseline
|
3.25 Scores on a scale
Standard Deviation 1.08
|
2.88 Scores on a scale
Standard Deviation 1.31
|
|
Metacognitive Capacity
IIPI-Understanding Others-21 days after dis meds
|
2.75 Scores on a scale
Standard Deviation 0.50
|
2.50 Scores on a scale
Standard Deviation 1.00
|
|
Metacognitive Capacity
IIPI - Decentration - Baseline
|
0.50 Scores on a scale
Standard Deviation 0.45
|
0.38 Scores on a scale
Standard Deviation 0.48
|
|
Metacognitive Capacity
IIPI-Decentration-21 days after dis meds
|
0.38 Scores on a scale
Standard Deviation 0.75
|
0.20 Scores on a scale
Standard Deviation 0.45
|
|
Metacognitive Capacity
IIPI - Mastery - Baseline
|
2.67 Scores on a scale
Standard Deviation 1.89
|
3.88 Scores on a scale
Standard Deviation 2.10
|
|
Metacognitive Capacity
IIPI-Mastery-21 days after dis meds
|
2.75 Scores on a scale
Standard Deviation 0.50
|
2.80 Scores on a scale
Standard Deviation 1.64
|
|
Metacognitive Capacity
IIPI - Total - Baseline
|
11.50 Scores on a scale
Standard Deviation 4.69
|
11.75 Scores on a scale
Standard Deviation 4.99
|
|
Metacognitive Capacity
IIPI-Total-21 days after dis meds
|
11.13 Scores on a scale
Standard Deviation 2.95
|
9.40 Scores on a scale
Standard Deviation 2.43
|
SECONDARY outcome
Timeframe: Baseline, 7 days of study medication (Visit 4), 21 days after discontinuation of study medication (Visit 6)The Clinical Global Impressions Severity Scale (CGI-S) is used for repeated evaluations of global psychopathology. The CGI-S scale is widely used in schizophrenia research and is a single 7-point Likert scale rating severity of psychopathology on a scale of 1 (normal, not ill) to 7 (very severely ill), with a higher score indicating more severity.
Outcome measures
| Measure |
Mifepristone
n=10 Participants
Mifepristone 600mg once daily x 7 days
mifepristone: Mifepristone 600mg (3x200mg tablets) once daily for seven days
|
Placebo
n=12 Participants
Matching placebo tablets one daily
Placebo: 3 tablets once daily for seven days
|
|---|---|---|
|
Symptom Change - CGI-S
CGI-S - Baseline
|
4.30 Scores on a scale
Standard Deviation 0.67
|
4.42 Scores on a scale
Standard Deviation 0.90
|
|
Symptom Change - CGI-S
CGI-S - 7 days of study med
|
4.20 Scores on a scale
Standard Deviation 1.03
|
4.09 Scores on a scale
Standard Deviation 1.04
|
|
Symptom Change - CGI-S
CGI-S - 21 days after disc of study med
|
3.89 Scores on a scale
Standard Deviation 0.93
|
3.70 Scores on a scale
Standard Deviation 0.95
|
SECONDARY outcome
Timeframe: 7 days of study medication (Visit 4), 21 days after discontinuation of study medication (Visit 6)Population: The CGI-I is measured at visits after baseline, there was 1 subject taking Placebo who discontinued prior to Visit 4 and therefore was not included in analysis.
The Clinical Global Impressions Improvement (CGI-I) scale is used to assess the clinical change as compared to symptoms at baseline using a 7-point Likert scale, ranging from very much improved (1) to very much worse (7), with a higher score indicating more severity.
Outcome measures
| Measure |
Mifepristone
n=10 Participants
Mifepristone 600mg once daily x 7 days
mifepristone: Mifepristone 600mg (3x200mg tablets) once daily for seven days
|
Placebo
n=11 Participants
Matching placebo tablets one daily
Placebo: 3 tablets once daily for seven days
|
|---|---|---|
|
Symptom Change - CGI-I
CGI-I - 7 days of study med
|
3.30 Scores on a scale
Standard Deviation 1.16
|
3.36 Scores on a scale
Standard Deviation 1.29
|
|
Symptom Change - CGI-I
CGI-I - 21 days after disc of study med
|
3.44 Scores on a scale
Standard Deviation 1.01
|
2.80 Scores on a scale
Standard Deviation 1.14
|
SECONDARY outcome
Timeframe: 7 days of study medication (Visit 4)Borderline Personality Disorder Severity Index (BPDSI) symptom domain subscales scores. The BPDSI is a semi-structured clinical interview assessing the frequency and severity of manifestations of Borderline Personality Disorder (BPD) during a circumscribed period of the previous 7 days. The BPDSI measures 9 symptoms associated with BPD on a Likert scale ranging from 0-7 (0 = never; 7 = daily). Each symptom measure produces a mean score ranging from 0-7, with a higher score indicating more prevalent symptoms.
Outcome measures
| Measure |
Mifepristone
n=10 Participants
Mifepristone 600mg once daily x 7 days
mifepristone: Mifepristone 600mg (3x200mg tablets) once daily for seven days
|
Placebo
n=12 Participants
Matching placebo tablets one daily
Placebo: 3 tablets once daily for seven days
|
|---|---|---|
|
Symptom Change - BPDSI Subscales
BPDSI Subscale Score - Emptiness
|
2.76 Scores on a scale
Standard Deviation 1.81
|
1.51 Scores on a scale
Standard Deviation 0.91
|
|
Symptom Change - BPDSI Subscales
BPDSI Subscale Score - Abandonment
|
0.90 Scores on a scale
Standard Deviation 0.59
|
1.27 Scores on a scale
Standard Deviation 1.15
|
|
Symptom Change - BPDSI Subscales
BPDSI Subscale Score - Interpersonal Relationships
|
0.80 Scores on a scale
Standard Deviation 0.54
|
0.58 Scores on a scale
Standard Deviation 0.53
|
|
Symptom Change - BPDSI Subscales
BPDSI Subscale Score - Identity
|
1.64 Scores on a scale
Standard Deviation 1.13
|
1.34 Scores on a scale
Standard Deviation 0.85
|
|
Symptom Change - BPDSI Subscales
BPDSI Subscale Score - Impulsivity
|
0.66 Scores on a scale
Standard Deviation 0.64
|
0.11 Scores on a scale
Standard Deviation 0.17
|
|
Symptom Change - BPDSI Subscales
BPDSI Subscale Score - Parasuicidal Behavior
|
0.37 Scores on a scale
Standard Deviation 0.52
|
0.19 Scores on a scale
Standard Deviation 0.37
|
|
Symptom Change - BPDSI Subscales
BPDSI Subscale Score - Affective Instability
|
3.67 Scores on a scale
Standard Deviation 2.43
|
2.89 Scores on a scale
Standard Deviation 1.90
|
|
Symptom Change - BPDSI Subscales
BPDSI Subscale Score - Outbursts of Anger
|
1.08 Scores on a scale
Standard Deviation 1.20
|
0.79 Scores on a scale
Standard Deviation 0.92
|
|
Symptom Change - BPDSI Subscales
BPDSI Sub. Score-Dissociation & Paranoid Ideation
|
1.63 Scores on a scale
Standard Deviation 1.26
|
0.77 Scores on a scale
Standard Deviation 0.84
|
SECONDARY outcome
Timeframe: 21 days after discontinuation of study medication (Visit 6)Borderline Personality Disorder Severity Index (BPDSI) symptom domain subscales scores. The BPDSI is a semi-structured clinical interview assessing the frequency and severity of manifestations of Borderline Personality Disorder (BPD) during a circumscribed period of the previous 7 days. The BPDSI measures 9 symptoms associated with BPD on a Likert scale ranging from 0-7 (0 = never; 7 = daily). Each symptom measure produces a mean score ranging from 0-7, with a higher score indicating more prevalent symptoms.
Outcome measures
| Measure |
Mifepristone
n=10 Participants
Mifepristone 600mg once daily x 7 days
mifepristone: Mifepristone 600mg (3x200mg tablets) once daily for seven days
|
Placebo
n=12 Participants
Matching placebo tablets one daily
Placebo: 3 tablets once daily for seven days
|
|---|---|---|
|
Symptom Change - BPDSI Subscales
BPDSI Subscale Score - Abandonment
|
1.06 Scores on a scale
Standard Deviation 0.75
|
0.63 Scores on a scale
Standard Deviation 0.67
|
|
Symptom Change - BPDSI Subscales
BPDSI Subscale Score - Affective Instability
|
3.27 Scores on a scale
Standard Deviation 2.10
|
2.96 Scores on a scale
Standard Deviation 1.60
|
|
Symptom Change - BPDSI Subscales
BPDSI Sub. Score-Dissociation & Paranoid Ideation
|
1.62 Scores on a scale
Standard Deviation 1.03
|
0.56 Scores on a scale
Standard Deviation 0.58
|
|
Symptom Change - BPDSI Subscales
BPDSI Subscale Score - Interpersonal Relationships
|
0.84 Scores on a scale
Standard Deviation 0.86
|
0.64 Scores on a scale
Standard Deviation 0.88
|
|
Symptom Change - BPDSI Subscales
BPDSI Subscale Score - Identity
|
1.92 Scores on a scale
Standard Deviation 1.12
|
0.63 Scores on a scale
Standard Deviation 0.76
|
|
Symptom Change - BPDSI Subscales
BPDSI Subscale Score - Impulsivity
|
0.53 Scores on a scale
Standard Deviation 0.58
|
0.11 Scores on a scale
Standard Deviation 0.14
|
|
Symptom Change - BPDSI Subscales
BPDSI Subscale Score - Parasuicidal Behavior
|
0.43 Scores on a scale
Standard Deviation 0.38
|
0.25 Scores on a scale
Standard Deviation 0.37
|
|
Symptom Change - BPDSI Subscales
BPDSI Subscale Score - Emptiness
|
2.94 Scores on a scale
Standard Deviation 1.86
|
1.79 Scores on a scale
Standard Deviation 1.67
|
|
Symptom Change - BPDSI Subscales
BPDSI Subscale Score - Outbursts of Anger
|
0.97 Scores on a scale
Standard Deviation 1.22
|
0.62 Scores on a scale
Standard Deviation 1.07
|
SECONDARY outcome
Timeframe: 7 days of study medication (Visit 4)The Symptom Checklist-90-Revised (SCL-90-R) instrument helps evaluate a broad range of psychological problems and symptoms of psychopathology. The instrument is also useful in measuring patient progress or treatment outcomes. The SCL-90-R contains 90 items on a 5-point rating scale, with a higher score indicating more severity. The items are categorized into 12 domains (9 scores along primary symptom dimensions and 3 scores among global distress indices). A t-score for each domain is then obtained by norming by sex and ranges between 19-81, with a higher score indicating more severity.
Outcome measures
| Measure |
Mifepristone
n=10 Participants
Mifepristone 600mg once daily x 7 days
mifepristone: Mifepristone 600mg (3x200mg tablets) once daily for seven days
|
Placebo
n=12 Participants
Matching placebo tablets one daily
Placebo: 3 tablets once daily for seven days
|
|---|---|---|
|
Symptom Change - SCL-90-R
SCL-90-R - Depression
|
52.60 Scores on a scale
Standard Deviation 9.32
|
47.82 Scores on a scale
Standard Deviation 10.05
|
|
Symptom Change - SCL-90-R
SCl-90-R - Somatization
|
53.00 Scores on a scale
Standard Deviation 10.92
|
46.27 Scores on a scale
Standard Deviation 9.18
|
|
Symptom Change - SCL-90-R
SCL-90-R - Obsessive-Complusive
|
54.30 Scores on a scale
Standard Deviation 11.49
|
47.91 Scores on a scale
Standard Deviation 9.69
|
|
Symptom Change - SCL-90-R
SCL-90-R - Interpersonal Sensitivity
|
53.00 Scores on a scale
Standard Deviation 10.07
|
48.45 Scores on a scale
Standard Deviation 10.05
|
|
Symptom Change - SCL-90-R
SCL-90-R - Anxiety
|
49.10 Scores on a scale
Standard Deviation 10.08
|
43.09 Scores on a scale
Standard Deviation 9.39
|
|
Symptom Change - SCL-90-R
SCL-90-R - Hostility
|
52.80 Scores on a scale
Standard Deviation 9.07
|
52.00 Scores on a scale
Standard Deviation 10.85
|
|
Symptom Change - SCL-90-R
SCL-90-R - Phobic Anxiety
|
49.60 Scores on a scale
Standard Deviation 6.59
|
49.55 Scores on a scale
Standard Deviation 7.88
|
|
Symptom Change - SCL-90-R
SCL-90-R - Paranoid Ideation
|
53.80 Scores on a scale
Standard Deviation 10.38
|
47.91 Scores on a scale
Standard Deviation 8.88
|
|
Symptom Change - SCL-90-R
SCL-90-R - Psychoticism
|
48.80 Scores on a scale
Standard Deviation 8.16
|
47.27 Scores on a scale
Standard Deviation 10.67
|
|
Symptom Change - SCL-90-R
SCL-90-R - Global Severity Index
|
52.30 Scores on a scale
Standard Deviation 9.89
|
45.82 Scores on a scale
Standard Deviation 9.29
|
|
Symptom Change - SCL-90-R
SCL-90-R - Positive Symptom Total
|
53.40 Scores on a scale
Standard Deviation 11.89
|
46.91 Scores on a scale
Standard Deviation 9.69
|
|
Symptom Change - SCL-90-R
SCL-90-R - Positive Symptom Distress Index
|
54.20 Scores on a scale
Standard Deviation 11.49
|
51.91 Scores on a scale
Standard Deviation 17.04
|
SECONDARY outcome
Timeframe: 21 days after discontinuation of study medication (Visit 6)The Symptom Checklist-90-Revised (SCL-90-R) instrument helps evaluate a broad range of psychological problems and symptoms of psychopathology. The instrument is also useful in measuring patient progress or treatment outcomes. The SCL-90-R contains 90 items on a 5-point rating scale, with a higher score indicating more severity. The items are categorized into 12 domains (9 scores along primary symptom dimensions and 3 scores among global distress indices). A t-score for each domain is then obtained by norming by sex and ranges between 19-81, with a higher score indicating more severity.
Outcome measures
| Measure |
Mifepristone
n=10 Participants
Mifepristone 600mg once daily x 7 days
mifepristone: Mifepristone 600mg (3x200mg tablets) once daily for seven days
|
Placebo
n=12 Participants
Matching placebo tablets one daily
Placebo: 3 tablets once daily for seven days
|
|---|---|---|
|
Symptom Change - SCL-90-R
SCL-90-R - Obsessive-Complusive
|
51.33 Scores on a scale
Standard Deviation 9.80
|
44.60 Scores on a scale
Standard Deviation 12.69
|
|
Symptom Change - SCL-90-R
SCl-90-R - Somatization
|
49.78 Scores on a scale
Standard Deviation 15.21
|
47.60 Scores on a scale
Standard Deviation 10.70
|
|
Symptom Change - SCL-90-R
SCL-90-R - Interpersonal Sensitivity
|
48.89 Scores on a scale
Standard Deviation 10.48
|
45.30 Scores on a scale
Standard Deviation 8.79
|
|
Symptom Change - SCL-90-R
SCL-90-R - Depression
|
49.00 Scores on a scale
Standard Deviation 9.86
|
44.00 Scores on a scale
Standard Deviation 12.44
|
|
Symptom Change - SCL-90-R
SCL-90-R - Anxiety
|
48.44 Scores on a scale
Standard Deviation 9.25
|
42.70 Scores on a scale
Standard Deviation 10.27
|
|
Symptom Change - SCL-90-R
SCL-90-R - Hostility
|
50.11 Scores on a scale
Standard Deviation 12.50
|
48.80 Scores on a scale
Standard Deviation 6.84
|
|
Symptom Change - SCL-90-R
SCL-90-R - Phobic Anxiety
|
46.00 Scores on a scale
Standard Deviation 6.96
|
50.10 Scores on a scale
Standard Deviation 8.75
|
|
Symptom Change - SCL-90-R
SCL-90-R - Paranoid Ideation
|
50.33 Scores on a scale
Standard Deviation 10.48
|
46.80 Scores on a scale
Standard Deviation 12.56
|
|
Symptom Change - SCL-90-R
SCL-90-R - Psychoticism
|
45.44 Scores on a scale
Standard Deviation 8.50
|
45.70 Scores on a scale
Standard Deviation 13.31
|
|
Symptom Change - SCL-90-R
SCL-90-R - Global Severity Index
|
49.00 Scores on a scale
Standard Deviation 10.30
|
45.10 Scores on a scale
Standard Deviation 12.05
|
|
Symptom Change - SCL-90-R
SCL-90-R - Positive Symptom Total
|
49.56 Scores on a scale
Standard Deviation 11.22
|
44.80 Scores on a scale
Standard Deviation 10.40
|
|
Symptom Change - SCL-90-R
SCL-90-R - Positive Symptom Distress Index
|
51.67 Scores on a scale
Standard Deviation 13.19
|
46.60 Scores on a scale
Standard Deviation 12.47
|
Adverse Events
Mifepristone
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Mifepristone
n=10 participants at risk
Mifepristone 600mg once daily x 7 days
mifepristone: Mifepristone 600mg (3x200mg tablets) once daily for seven days
|
Placebo
n=12 participants at risk
Matching placebo tablets one daily
Placebo: 3 tablets once daily for seven days
|
|---|---|---|
|
Renal and urinary disorders
Foreign body in urethra
|
0.00%
0/10 • Screening through 21 days after study medication was discontinued
|
8.3%
1/12 • Number of events 1 • Screening through 21 days after study medication was discontinued
|
Other adverse events
| Measure |
Mifepristone
n=10 participants at risk
Mifepristone 600mg once daily x 7 days
mifepristone: Mifepristone 600mg (3x200mg tablets) once daily for seven days
|
Placebo
n=12 participants at risk
Matching placebo tablets one daily
Placebo: 3 tablets once daily for seven days
|
|---|---|---|
|
Cardiac disorders
Abnormal electrocardiogram
|
20.0%
2/10 • Number of events 2 • Screening through 21 days after study medication was discontinued
|
8.3%
1/12 • Number of events 1 • Screening through 21 days after study medication was discontinued
|
|
Gastrointestinal disorders
Abdominal bloating
|
0.00%
0/10 • Screening through 21 days after study medication was discontinued
|
8.3%
1/12 • Number of events 1 • Screening through 21 days after study medication was discontinued
|
|
Gastrointestinal disorders
Abdominal Pain
|
10.0%
1/10 • Number of events 2 • Screening through 21 days after study medication was discontinued
|
16.7%
2/12 • Number of events 4 • Screening through 21 days after study medication was discontinued
|
|
Psychiatric disorders
Anxiety
|
10.0%
1/10 • Number of events 1 • Screening through 21 days after study medication was discontinued
|
8.3%
1/12 • Number of events 1 • Screening through 21 days after study medication was discontinued
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/10 • Screening through 21 days after study medication was discontinued
|
8.3%
1/12 • Number of events 1 • Screening through 21 days after study medication was discontinued
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/10 • Screening through 21 days after study medication was discontinued
|
8.3%
1/12 • Number of events 2 • Screening through 21 days after study medication was discontinued
|
|
Skin and subcutaneous tissue disorders
Atopic Dermatitis
|
0.00%
0/10 • Screening through 21 days after study medication was discontinued
|
8.3%
1/12 • Number of events 1 • Screening through 21 days after study medication was discontinued
|
|
Eye disorders
Blurry Vision
|
20.0%
2/10 • Number of events 2 • Screening through 21 days after study medication was discontinued
|
0.00%
0/12 • Screening through 21 days after study medication was discontinued
|
|
Skin and subcutaneous tissue disorders
Bug Bites
|
10.0%
1/10 • Number of events 1 • Screening through 21 days after study medication was discontinued
|
0.00%
0/12 • Screening through 21 days after study medication was discontinued
|
|
General disorders
Chills
|
0.00%
0/10 • Screening through 21 days after study medication was discontinued
|
8.3%
1/12 • Number of events 1 • Screening through 21 days after study medication was discontinued
|
|
Gastrointestinal disorders
Constipation
|
10.0%
1/10 • Number of events 1 • Screening through 21 days after study medication was discontinued
|
0.00%
0/12 • Screening through 21 days after study medication was discontinued
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
10.0%
1/10 • Number of events 1 • Screening through 21 days after study medication was discontinued
|
0.00%
0/12 • Screening through 21 days after study medication was discontinued
|
|
Reproductive system and breast disorders
Cramping
|
0.00%
0/10 • Screening through 21 days after study medication was discontinued
|
16.7%
2/12 • Number of events 2 • Screening through 21 days after study medication was discontinued
|
|
General disorders
Decreased Appetite
|
0.00%
0/10 • Screening through 21 days after study medication was discontinued
|
8.3%
1/12 • Number of events 1 • Screening through 21 days after study medication was discontinued
|
|
General disorders
Decreased Concentration
|
0.00%
0/10 • Screening through 21 days after study medication was discontinued
|
8.3%
1/12 • Number of events 2 • Screening through 21 days after study medication was discontinued
|
|
Gastrointestinal disorders
Diarrhea
|
10.0%
1/10 • Number of events 1 • Screening through 21 days after study medication was discontinued
|
16.7%
2/12 • Number of events 2 • Screening through 21 days after study medication was discontinued
|
|
General disorders
Dizziness
|
10.0%
1/10 • Number of events 1 • Screening through 21 days after study medication was discontinued
|
0.00%
0/12 • Screening through 21 days after study medication was discontinued
|
|
Skin and subcutaneous tissue disorders
Dog Bite Infection
|
10.0%
1/10 • Number of events 1 • Screening through 21 days after study medication was discontinued
|
0.00%
0/12 • Screening through 21 days after study medication was discontinued
|
|
Eye disorders
Dry Eyes
|
10.0%
1/10 • Number of events 1 • Screening through 21 days after study medication was discontinued
|
0.00%
0/12 • Screening through 21 days after study medication was discontinued
|
|
Reproductive system and breast disorders
Dysmenorrhea
|
10.0%
1/10 • Number of events 1 • Screening through 21 days after study medication was discontinued
|
0.00%
0/12 • Screening through 21 days after study medication was discontinued
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/10 • Screening through 21 days after study medication was discontinued
|
8.3%
1/12 • Number of events 1 • Screening through 21 days after study medication was discontinued
|
|
Psychiatric disorders
Exacerbation of borderline personality disorder
|
0.00%
0/10 • Screening through 21 days after study medication was discontinued
|
16.7%
2/12 • Number of events 2 • Screening through 21 days after study medication was discontinued
|
|
General disorders
Exhaustion
|
10.0%
1/10 • Number of events 1 • Screening through 21 days after study medication was discontinued
|
8.3%
1/12 • Number of events 1 • Screening through 21 days after study medication was discontinued
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
10.0%
1/10 • Number of events 1 • Screening through 21 days after study medication was discontinued
|
0.00%
0/12 • Screening through 21 days after study medication was discontinued
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.00%
0/10 • Screening through 21 days after study medication was discontinued
|
8.3%
1/12 • Number of events 1 • Screening through 21 days after study medication was discontinued
|
|
General disorders
Hand tremor
|
10.0%
1/10 • Number of events 1 • Screening through 21 days after study medication was discontinued
|
8.3%
1/12 • Number of events 1 • Screening through 21 days after study medication was discontinued
|
|
General disorders
Headache/migraine
|
30.0%
3/10 • Number of events 3 • Screening through 21 days after study medication was discontinued
|
33.3%
4/12 • Number of events 4 • Screening through 21 days after study medication was discontinued
|
|
Musculoskeletal and connective tissue disorders
Heaviness in legs
|
0.00%
0/10 • Screening through 21 days after study medication was discontinued
|
8.3%
1/12 • Number of events 1 • Screening through 21 days after study medication was discontinued
|
|
Renal and urinary disorders
Hemorrhoids
|
10.0%
1/10 • Number of events 1 • Screening through 21 days after study medication was discontinued
|
0.00%
0/12 • Screening through 21 days after study medication was discontinued
|
|
Blood and lymphatic system disorders
Hypokalemia
|
20.0%
2/10 • Number of events 2 • Screening through 21 days after study medication was discontinued
|
8.3%
1/12 • Number of events 1 • Screening through 21 days after study medication was discontinued
|
|
General disorders
Increased appetite
|
0.00%
0/10 • Screening through 21 days after study medication was discontinued
|
8.3%
1/12 • Number of events 1 • Screening through 21 days after study medication was discontinued
|
|
General disorders
influenza
|
0.00%
0/10 • Screening through 21 days after study medication was discontinued
|
8.3%
1/12 • Number of events 1 • Screening through 21 days after study medication was discontinued
|
|
General disorders
insomnia
|
10.0%
1/10 • Number of events 1 • Screening through 21 days after study medication was discontinued
|
0.00%
0/12 • Screening through 21 days after study medication was discontinued
|
|
General disorders
Irritability
|
0.00%
0/10 • Screening through 21 days after study medication was discontinued
|
16.7%
2/12 • Number of events 2 • Screening through 21 days after study medication was discontinued
|
|
Reproductive system and breast disorders
lactation
|
0.00%
0/10 • Screening through 21 days after study medication was discontinued
|
8.3%
1/12 • Number of events 1 • Screening through 21 days after study medication was discontinued
|
|
Respiratory, thoracic and mediastinal disorders
lump in throat
|
10.0%
1/10 • Number of events 1 • Screening through 21 days after study medication was discontinued
|
0.00%
0/12 • Screening through 21 days after study medication was discontinued
|
|
Reproductive system and breast disorders
menstural bleeding
|
10.0%
1/10 • Number of events 1 • Screening through 21 days after study medication was discontinued
|
8.3%
1/12 • Number of events 2 • Screening through 21 days after study medication was discontinued
|
|
General disorders
mouth sores
|
10.0%
1/10 • Number of events 1 • Screening through 21 days after study medication was discontinued
|
0.00%
0/12 • Screening through 21 days after study medication was discontinued
|
|
Gastrointestinal disorders
Nausea
|
50.0%
5/10 • Number of events 6 • Screening through 21 days after study medication was discontinued
|
16.7%
2/12 • Number of events 2 • Screening through 21 days after study medication was discontinued
|
|
Musculoskeletal and connective tissue disorders
Pain
|
30.0%
3/10 • Number of events 3 • Screening through 21 days after study medication was discontinued
|
8.3%
1/12 • Number of events 1 • Screening through 21 days after study medication was discontinued
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngitis
|
0.00%
0/10 • Screening through 21 days after study medication was discontinued
|
8.3%
1/12 • Number of events 1 • Screening through 21 days after study medication was discontinued
|
|
Musculoskeletal and connective tissue disorders
Pre-existing restless leg syndrome
|
10.0%
1/10 • Number of events 1 • Screening through 21 days after study medication was discontinued
|
0.00%
0/12 • Screening through 21 days after study medication was discontinued
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
20.0%
2/10 • Number of events 2 • Screening through 21 days after study medication was discontinued
|
0.00%
0/12 • Screening through 21 days after study medication was discontinued
|
|
Skin and subcutaneous tissue disorders
Rash
|
30.0%
3/10 • Number of events 3 • Screening through 21 days after study medication was discontinued
|
0.00%
0/12 • Screening through 21 days after study medication was discontinued
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
10.0%
1/10 • Number of events 1 • Screening through 21 days after study medication was discontinued
|
0.00%
0/12 • Screening through 21 days after study medication was discontinued
|
|
Musculoskeletal and connective tissue disorders
Shakiness
|
0.00%
0/10 • Screening through 21 days after study medication was discontinued
|
8.3%
1/12 • Number of events 1 • Screening through 21 days after study medication was discontinued
|
|
General disorders
Sinus congestion
|
10.0%
1/10 • Number of events 1 • Screening through 21 days after study medication was discontinued
|
0.00%
0/12 • Screening through 21 days after study medication was discontinued
|
|
General disorders
Somnolence
|
30.0%
3/10 • Number of events 3 • Screening through 21 days after study medication was discontinued
|
0.00%
0/12 • Screening through 21 days after study medication was discontinued
|
|
General disorders
Toothache
|
0.00%
0/10 • Screening through 21 days after study medication was discontinued
|
8.3%
1/12 • Number of events 1 • Screening through 21 days after study medication was discontinued
|
|
Infections and infestations
Upper respiratory infection
|
10.0%
1/10 • Number of events 1 • Screening through 21 days after study medication was discontinued
|
16.7%
2/12 • Number of events 2 • Screening through 21 days after study medication was discontinued
|
|
Renal and urinary disorders
Urinary tract infection
|
0.00%
0/10 • Screening through 21 days after study medication was discontinued
|
25.0%
3/12 • Number of events 3 • Screening through 21 days after study medication was discontinued
|
|
Skin and subcutaneous tissue disorders
worsening acne
|
0.00%
0/10 • Screening through 21 days after study medication was discontinued
|
8.3%
1/12 • Number of events 1 • Screening through 21 days after study medication was discontinued
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place