Trial Outcomes & Findings for Ganaxolone in Posttraumatic Stress Disorder (PTSD) (NCT NCT01339689)
NCT ID: NCT01339689
Last Updated: 2022-12-29
Results Overview
The CAPS was a structured interview that queries participants about each of the 17 Diagnostic and Statistical manual of Mental Disorders IV (DSM-IV) criteria B, C, and D symptoms of PTSD. Each item has a frequency score (0-4) and intensity score (0-4). The CAPS total score is the sum of frequency and intensity ratings for each item and the score range was 0: no symptoms to 136: severe symptoms. Higher score indicates worse symptoms. Baseline was defined as the Day 0 assessment before study drug infusion. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
COMPLETED
PHASE2
112 participants
Baseline (Week 0) and at Week 2, Week 4 and Week 6
2022-12-29
Participant Flow
Participant milestones
| Measure |
Ganaxolone
active
Ganaxolone: 200-600 milligram (mg) twice daily (bid), capsules, up to 12 weeks
|
Placebo
non-active
Placebo: capsules, bid, up to 12 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
59
|
53
|
|
Overall Study
COMPLETED
|
42
|
44
|
|
Overall Study
NOT COMPLETED
|
17
|
9
|
Reasons for withdrawal
| Measure |
Ganaxolone
active
Ganaxolone: 200-600 milligram (mg) twice daily (bid), capsules, up to 12 weeks
|
Placebo
non-active
Placebo: capsules, bid, up to 12 weeks
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
9
|
3
|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
|
Overall Study
Noncompliance
|
1
|
0
|
|
Overall Study
Relocated out of area
|
0
|
1
|
|
Overall Study
Other
|
2
|
2
|
|
Overall Study
multiple reasons
|
1
|
1
|
Baseline Characteristics
Ganaxolone in Posttraumatic Stress Disorder (PTSD)
Baseline characteristics by cohort
| Measure |
Ganaxolone
n=59 Participants
active
Ganaxolone: 200-600 mg bid, capsules, up to 12 weeks
|
Placebo
n=53 Participants
non-active
Placebo: capsules, bid, up to 12 weeks
|
Total
n=112 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38.78 years
STANDARD_DEVIATION 10.54 • n=5 Participants
|
37.74 years
STANDARD_DEVIATION 10.86 • n=7 Participants
|
38.29 years
STANDARD_DEVIATION 10.66 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
50 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 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
|
19 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Week 0) and at Week 2, Week 4 and Week 6Population: mITT Population. Only those participants with data available at the specified data points were analyzed.
The CAPS was a structured interview that queries participants about each of the 17 Diagnostic and Statistical manual of Mental Disorders IV (DSM-IV) criteria B, C, and D symptoms of PTSD. Each item has a frequency score (0-4) and intensity score (0-4). The CAPS total score is the sum of frequency and intensity ratings for each item and the score range was 0: no symptoms to 136: severe symptoms. Higher score indicates worse symptoms. Baseline was defined as the Day 0 assessment before study drug infusion. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Placebo
n=50 Participants
non-active Placebo: capsules, bid, up to 12 weeks
|
Ganaxolone
n=49 Participants
active Ganaxolone: 200-600 mg bid, capsules, up to 12 weeks
|
|---|---|---|
|
Change From Baseline in Clinician-Administered Posttrautamtic Stress Disorder (PTSD) Scale (CAPS) to Week 6
Week 2
|
65.78 Scores on a scale
Standard Deviation 24.4
|
62.67 Scores on a scale
Standard Deviation 21.39
|
|
Change From Baseline in Clinician-Administered Posttrautamtic Stress Disorder (PTSD) Scale (CAPS) to Week 6
Week 4
|
63.2 Scores on a scale
Standard Deviation 23.06
|
61.30 Scores on a scale
Standard Deviation 23.42
|
|
Change From Baseline in Clinician-Administered Posttrautamtic Stress Disorder (PTSD) Scale (CAPS) to Week 6
Week 6
|
60.64 Scores on a scale
Standard Deviation 27.54
|
54.05 Scores on a scale
Standard Deviation 25.86
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and at Week 2, Week 4 and Week 6Population: mITT Population. Only those participants with data available at the specified data points were analyzed
The CAPS was a structured interview that queries participants about each of the 17 Diagnostic and Statistical manual of Mental Disorders IV (DSM-IV) criteria B, C, and D symptoms of PTSD. Each item has a frequency score (0-4) and intensity score (0-4). The Re-experience score is the sum of frequency and intensity ratings for items from cluster B and the score range was 0: no symptoms to 40: severe symptoms. Higher score indicates worse symptoms. Baseline was defined as the Day 0 assessment before study drug infusion. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Placebo
n=50 Participants
non-active Placebo: capsules, bid, up to 12 weeks
|
Ganaxolone
n=49 Participants
active Ganaxolone: 200-600 mg bid, capsules, up to 12 weeks
|
|---|---|---|
|
Change From Baseline in PTSD Re-Experience Score
Week 2
|
16.56 Scores on a scale
Standard Deviation 10.61
|
14.45 Scores on a scale
Standard Deviation 8.98
|
|
Change From Baseline in PTSD Re-Experience Score
Week 4
|
16.54 Scores on a scale
Standard Deviation 8.03
|
14.16 Scores on a scale
Standard Deviation 8.83
|
|
Change From Baseline in PTSD Re-Experience Score
Week 6
|
15.5 Scores on a scale
Standard Deviation 11.11
|
12.31 Scores on a scale
Standard Deviation 9.28
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and at Week 2, Week 4 and Week 6Population: mITT Population. Only those participants with data available at the specified data points were analyzed.
The CAPS was a structured interview that queries participants about each of the 17 Diagnostic and Statistical manual of Mental Disorders IV (DSM-IV) criteria B, C, and D symptoms of PTSD. Each item has a frequency score (0-4) and intensity score (0-4). The Avoidance score is the sum of frequency and intensity ratings for items from cluster C.and the score range was 0: no symptoms to 56: severe symptoms. Higher score indicates worse symptoms. Baseline was defined as the Day 0 assessment before study drug infusion. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Placebo
n=50 Participants
non-active Placebo: capsules, bid, up to 12 weeks
|
Ganaxolone
n=49 Participants
active Ganaxolone: 200-600 mg bid, capsules, up to 12 weeks
|
|---|---|---|
|
Change From Baseline in PTSD Avoidance Score
Week 2
|
27.06 Scores on a scale
Standard Deviation 11.54
|
26.29 Scores on a scale
Standard Deviation 10.76
|
|
Change From Baseline in PTSD Avoidance Score
Week 4
|
25.87 Scores on a scale
Standard Deviation 11.69
|
26.09 Scores on a scale
Standard Deviation 11.87
|
|
Change From Baseline in PTSD Avoidance Score
Week 6
|
24.82 Scores on a scale
Standard Deviation 11.45
|
23.52 Scores on a scale
Standard Deviation 13.1
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and at Week 2, Week 4 and Week 6Population: mITT Population. Only those participants with data available at the specified data points were analyzed.
The CAPS was a structured interview that queries participants about each of the 17 Diagnostic and Statistical manual of Mental Disorders IV (DSM-IV) criteria B, C, and D symptoms of PTSD. Each item has a frequency score (0-4) and intensity score (0-4). The Hyperarousal score is the sum of frequency and intensity ratings for items from cluster D and the score range was 0: no symptoms to 40: severe symptoms. Higher score indicates worse symptoms. Baseline was defined as the Day 0 assessment before study drug infusion. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Placebo
n=50 Participants
non-active Placebo: capsules, bid, up to 12 weeks
|
Ganaxolone
n=49 Participants
active Ganaxolone: 200-600 mg bid, capsules, up to 12 weeks
|
|---|---|---|
|
Change From Baseline in PTSD Hyperarousal Score
Week 2
|
22.16 Scores on a scale
Standard Deviation 7.73
|
21.94 Scores on a scale
Standard Deviation 7.76
|
|
Change From Baseline in PTSD Hyperarousal Score
Week 4
|
20.78 Scores on a scale
Standard Deviation 7.8
|
21.05 Scores on a scale
Standard Deviation 8.48
|
|
Change From Baseline in PTSD Hyperarousal Score
Week 6
|
20.32 Scores on a scale
Standard Deviation 9.07
|
18.21 Scores on a scale
Standard Deviation 8.55
|
SECONDARY outcome
Timeframe: Week 2, Week 4 and Week 6Population: mITT Population. Only those participants with data available at the specified data points were analyzed
The CGI-II scale is a 7-point scale where the investigator was required to assess how much the participant's illness has improved or worsened relative to a Baseline state at the beginning of the intervention, and rated as 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. Higher score indicated worse symptoms. The score was grouped into two categories for analysis: Responders=1 or 2, Non-responders=3-7.
Outcome measures
| Measure |
Placebo
n=49 Participants
non-active Placebo: capsules, bid, up to 12 weeks
|
Ganaxolone
n=48 Participants
active Ganaxolone: 200-600 mg bid, capsules, up to 12 weeks
|
|---|---|---|
|
Number of Participants With Response to Clinical Global Impression - Improvement (Investigator) (CGI-II) Scale
Week 2 - Non-Responder
|
42 Participants
|
45 Participants
|
|
Number of Participants With Response to Clinical Global Impression - Improvement (Investigator) (CGI-II) Scale
Week 2 - Responder
|
7 Participants
|
3 Participants
|
|
Number of Participants With Response to Clinical Global Impression - Improvement (Investigator) (CGI-II) Scale
Week 4 - Non-Responder
|
37 Participants
|
38 Participants
|
|
Number of Participants With Response to Clinical Global Impression - Improvement (Investigator) (CGI-II) Scale
Week 4 - Responder
|
9 Participants
|
5 Participants
|
|
Number of Participants With Response to Clinical Global Impression - Improvement (Investigator) (CGI-II) Scale
Week 6 - Non-Responder
|
32 Participants
|
27 Participants
|
|
Number of Participants With Response to Clinical Global Impression - Improvement (Investigator) (CGI-II) Scale
Week 6 - Responder
|
12 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Week 2, Week 4 and Week 6Population: mITT Population. Only those participants with data available at the specified data points were analyzed
The CGI-IS scale is a 7-point scale where the participant assesses how much the illness has improved or worsened relative to a Baseline state at the beginning of the intervention, and rated as 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. Higher score indicated worse symptoms. The score was grouped into two categories for analysis: Responders=1 or 2, Non-responders=3-7.
Outcome measures
| Measure |
Placebo
n=50 Participants
non-active Placebo: capsules, bid, up to 12 weeks
|
Ganaxolone
n=48 Participants
active Ganaxolone: 200-600 mg bid, capsules, up to 12 weeks
|
|---|---|---|
|
Number of Participants With Response to CGI-I Subject Scale Clinical Global Impression - Improvement (Subject) (CGI-IS) Scale
Week 2 - Non-Responder
|
45 Participants
|
46 Participants
|
|
Number of Participants With Response to CGI-I Subject Scale Clinical Global Impression - Improvement (Subject) (CGI-IS) Scale
Week 2 - Responder
|
5 Participants
|
2 Participants
|
|
Number of Participants With Response to CGI-I Subject Scale Clinical Global Impression - Improvement (Subject) (CGI-IS) Scale
Week 4 - Non-Responder
|
39 Participants
|
37 Participants
|
|
Number of Participants With Response to CGI-I Subject Scale Clinical Global Impression - Improvement (Subject) (CGI-IS) Scale
Week 4 - Responder
|
7 Participants
|
6 Participants
|
|
Number of Participants With Response to CGI-I Subject Scale Clinical Global Impression - Improvement (Subject) (CGI-IS) Scale
Week 6 - Non-Responder
|
37 Participants
|
37 Participants
|
|
Number of Participants With Response to CGI-I Subject Scale Clinical Global Impression - Improvement (Subject) (CGI-IS) Scale
Week 6 - Responder
|
7 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and at Week 2, Week 4 and Week 6Population: mITT Population. Only those participants with data available at the specified data points were analyzed
The PCL is a 17-item self-report scale representing all DSM-IV criteria for PTSD, including re-experiencing, avoidance and numbing, and hyperarousal criteria. Each item is scored 1-5 (1=not at all; 2=a little bit; 3=moderately; 4=quite a bit; 5=extremely). The total score is the sum of 17 item scores and ranged from 17: no symptoms to 85: severe symptoms. Higher score indicated worse symptoms. Baseline was defined as the Day 0 assessment before study drug infusion. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Placebo
n=50 Participants
non-active Placebo: capsules, bid, up to 12 weeks
|
Ganaxolone
n=49 Participants
active Ganaxolone: 200-600 mg bid, capsules, up to 12 weeks
|
|---|---|---|
|
Change From Baseline in PTSD Checklist (PCL) Scores
Week 6
|
51.75 Scores on a scale
Standard Deviation 15.73
|
46.33 Scores on a scale
Standard Deviation 17.29
|
|
Change From Baseline in PTSD Checklist (PCL) Scores
Week 2
|
54.4 Scores on a scale
Standard Deviation 14.24
|
50.79 Scores on a scale
Standard Deviation 15.05
|
|
Change From Baseline in PTSD Checklist (PCL) Scores
Week 4
|
52.93 Scores on a scale
Standard Deviation 15.31
|
48.74 Scores on a scale
Standard Deviation 16.2
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Week 6Population: mITT Population. Only those participants with data available at the specified data points were analyzed
The POMS is a factor-analytically derived 65 item self-report inventory with 5-point measures of five dimensions of negative mood: anger/irritability, anxiety/tension, depression/dejection, confusion/bewilderment, and fatigue/inertia, as well as vigor/activity. Total score was calculated as Fatigue + Mood (sum \[Confusion, anger, Anxiety/Tension, Depression\])- Vigor. Score ranged from 0: no symptoms to 200: severe symptoms; higher score indicated worse symptoms. Baseline was defined as the Day 0 assessment before study drug infusion. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Placebo
n=45 Participants
non-active Placebo: capsules, bid, up to 12 weeks
|
Ganaxolone
n=42 Participants
active Ganaxolone: 200-600 mg bid, capsules, up to 12 weeks
|
|---|---|---|
|
Change From Baseline in Profile of Mood States (POMS) Total Score
|
80.07 Scores on a scale
Standard Deviation 50.21
|
66.98 Scores on a scale
Standard Deviation 45.29
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Week 6Population: mITT Population. Only those participants with data available at the specified data points were analyzed
The PHQ-9 is the nine-item depression scale of the Patient Health Questionnaire. The nine items of the PHQ-9 are based directly on the nine diagnostic criteria for major depressive disorder in the DSM-IV. Each item is scored 0-3 (0=not at all; 1=several days; 2=more than half the days; 3= nearly every day). The total score is the sum of 9 item scores and ranged 0: no depression to 27: severe depression. The higher the total score, the worse the depression. Baseline was defined as the Day 0 assessment before study drug infusion. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Placebo
n=46 Participants
non-active Placebo: capsules, bid, up to 12 weeks
|
Ganaxolone
n=45 Participants
active Ganaxolone: 200-600 mg bid, capsules, up to 12 weeks
|
|---|---|---|
|
Change From Baseline in Patient Health Questionnaire (PHQ-9) Score
|
12.13 Scores on a scale
Standard Deviation 7.47
|
10.71 Scores on a scale
Standard Deviation 6.99
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Week 6Population: mITT Population. Only those participants with data available at the specified data points were analyzed
The ISI is a self-rated questionnaire assessing the difficulty over the past two weeks with falling to sleep, awakening in the middle of the night, and early morning awakening, as well as the degree to which insomnia impairs daily function. It included 5 items (rst item has 3 sub-questions), so a total of 7 questions. Each question is scored 0-4 (0=none, 1=mild, 2=moderate, 3=severe, 4=very severe). The total score is the sum of 7 item scores and ranged from 0: no symptoms to 28: severe symptoms. Higher score indicated worse symptoms. Baseline was defined as the Day 0 assessment before study drug infusion. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Placebo
n=46 Participants
non-active Placebo: capsules, bid, up to 12 weeks
|
Ganaxolone
n=45 Participants
active Ganaxolone: 200-600 mg bid, capsules, up to 12 weeks
|
|---|---|---|
|
Change From Baseline in Insomnia Severity Index (ISI) Score
|
17.04 Scores on a scale
Standard Deviation 7.69
|
14.36 Scores on a scale
Standard Deviation 7.94
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Week 6Population: mITT Population. Only those participants with data available at the specified data points were analyzed
The CD-RISC comprises 25 items, each rated on a 5-point scale (0-4), with higher scores reflecting greater resilience that may be a target for treatment in stress disorders. The total score is the sum of 25 item scores and ranged from 0: no symptoms to 100: worse symptoms. Higher score indicates worse symptoms. Baseline was defined as the Day 0 assessment before study drug infusion. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value
Outcome measures
| Measure |
Placebo
n=45 Participants
non-active Placebo: capsules, bid, up to 12 weeks
|
Ganaxolone
n=44 Participants
active Ganaxolone: 200-600 mg bid, capsules, up to 12 weeks
|
|---|---|---|
|
Change From Baseline in Connor-Davidson Resilience Scale (CD-RISC) Score
|
60.84 Scores on a scale
Standard Deviation 20.67
|
61.01 Scores on a scale
Standard Deviation 19.56
|
Adverse Events
Ganaxolone
Placebo
Serious adverse events
| Measure |
Ganaxolone
n=59 participants at risk
active Ganaxolone: 200-600 mg bid, capsules, up to 12 weeks
|
Placebo
n=53 participants at risk
non-active Placebo: capsules, bid, up to 12 weeks
|
|---|---|---|
|
Psychiatric disorders
Suicidal Ideation
|
1.7%
1/59 • Up to Week 15
|
0.00%
0/53 • Up to Week 15
|
|
General disorders
Fever
|
1.7%
1/59 • Up to Week 15
|
0.00%
0/53 • Up to Week 15
|
|
Nervous system disorders
Dizziness
|
1.7%
1/59 • Up to Week 15
|
0.00%
0/53 • Up to Week 15
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.7%
1/59 • Up to Week 15
|
0.00%
0/53 • Up to Week 15
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.7%
1/59 • Up to Week 15
|
0.00%
0/53 • Up to Week 15
|
|
Nervous system disorders
Confusion
|
1.7%
1/59 • Up to Week 15
|
0.00%
0/53 • Up to Week 15
|
|
Nervous system disorders
Balance Issues
|
1.7%
1/59 • Up to Week 15
|
0.00%
0/53 • Up to Week 15
|
Other adverse events
| Measure |
Ganaxolone
n=59 participants at risk
active Ganaxolone: 200-600 mg bid, capsules, up to 12 weeks
|
Placebo
n=53 participants at risk
non-active Placebo: capsules, bid, up to 12 weeks
|
|---|---|---|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/59 • Up to Week 15
|
1.9%
1/53 • Up to Week 15
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/59 • Up to Week 15
|
1.9%
1/53 • Up to Week 15
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.4%
2/59 • Up to Week 15
|
1.9%
1/53 • Up to Week 15
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/59 • Up to Week 15
|
1.9%
1/53 • Up to Week 15
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/59 • Up to Week 15
|
1.9%
1/53 • Up to Week 15
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
1.7%
1/59 • Up to Week 15
|
0.00%
0/53 • Up to Week 15
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
1.7%
1/59 • Up to Week 15
|
0.00%
0/53 • Up to Week 15
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
1.7%
1/59 • Up to Week 15
|
1.9%
1/53 • Up to Week 15
|
|
Respiratory, thoracic and mediastinal disorders
Upper airway resistance syndrome
|
1.7%
1/59 • Up to Week 15
|
1.9%
1/53 • Up to Week 15
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.7%
1/59 • Up to Week 15
|
0.00%
0/53 • Up to Week 15
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/59 • Up to Week 15
|
1.9%
1/53 • Up to Week 15
|
|
Social circumstances
Suicide of companion
|
1.7%
1/59 • Up to Week 15
|
0.00%
0/53 • Up to Week 15
|
|
Surgical and medical procedures
Product used for unknown indication
|
1.7%
1/59 • Up to Week 15
|
0.00%
0/53 • Up to Week 15
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/59 • Up to Week 15
|
1.9%
1/53 • Up to Week 15
|
|
Psychiatric disorders
Tic
|
1.7%
1/59 • Up to Week 15
|
0.00%
0/53 • Up to Week 15
|
|
Renal and urinary disorders
Haematuria
|
1.7%
1/59 • Up to Week 15
|
1.9%
1/53 • Up to Week 15
|
|
Blood and lymphatic system disorders
Splenomegaly
|
1.7%
1/59 • Up to Week 15
|
0.00%
0/53 • Up to Week 15
|
|
Ear and labyrinth disorders
Vertigo
|
3.4%
2/59 • Up to Week 15
|
0.00%
0/53 • Up to Week 15
|
|
Eye disorders
Dry Eye
|
1.7%
1/59 • Up to Week 15
|
0.00%
0/53 • Up to Week 15
|
|
Eye disorders
Vision blurred
|
6.8%
4/59 • Up to Week 15
|
1.9%
1/53 • Up to Week 15
|
|
Gastrointestinal disorders
Abdominal discomfort
|
1.7%
1/59 • Up to Week 15
|
3.8%
2/53 • Up to Week 15
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/59 • Up to Week 15
|
1.9%
1/53 • Up to Week 15
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/59 • Up to Week 15
|
1.9%
1/53 • Up to Week 15
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/59 • Up to Week 15
|
1.9%
1/53 • Up to Week 15
|
|
Gastrointestinal disorders
Diarrhoea
|
3.4%
2/59 • Up to Week 15
|
5.7%
3/53 • Up to Week 15
|
|
Gastrointestinal disorders
Dry mouth
|
1.7%
1/59 • Up to Week 15
|
3.8%
2/53 • Up to Week 15
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
3.4%
2/59 • Up to Week 15
|
0.00%
0/53 • Up to Week 15
|
|
Gastrointestinal disorders
Nausea
|
1.7%
1/59 • Up to Week 15
|
3.8%
2/53 • Up to Week 15
|
|
Gastrointestinal disorders
Vomiting
|
1.7%
1/59 • Up to Week 15
|
1.9%
1/53 • Up to Week 15
|
|
General disorders
Chest discomfort
|
1.7%
1/59 • Up to Week 15
|
1.9%
1/53 • Up to Week 15
|
|
General disorders
Chest pain
|
1.7%
1/59 • Up to Week 15
|
1.9%
1/53 • Up to Week 15
|
|
Gastrointestinal disorders
Fatigue
|
8.5%
5/59 • Up to Week 15
|
3.8%
2/53 • Up to Week 15
|
|
General disorders
Feeling drunk
|
1.7%
1/59 • Up to Week 15
|
0.00%
0/53 • Up to Week 15
|
|
General disorders
Influenza like illness
|
0.00%
0/59 • Up to Week 15
|
1.9%
1/53 • Up to Week 15
|
|
General disorders
Irritability
|
1.7%
1/59 • Up to Week 15
|
1.9%
1/53 • Up to Week 15
|
|
General disorders
Pyrexia
|
0.00%
0/59 • Up to Week 15
|
1.9%
1/53 • Up to Week 15
|
|
General disorders
Sensation of pressure
|
0.00%
0/59 • Up to Week 15
|
1.9%
1/53 • Up to Week 15
|
|
Infections and infestations
Nasopharyngitis
|
3.4%
2/59 • Up to Week 15
|
0.00%
0/53 • Up to Week 15
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/59 • Up to Week 15
|
1.9%
1/53 • Up to Week 15
|
|
Infections and infestations
Pharyngitis streptococcal
|
1.7%
1/59 • Up to Week 15
|
0.00%
0/53 • Up to Week 15
|
|
Infections and infestations
Rhinitis
|
0.00%
0/59 • Up to Week 15
|
1.9%
1/53 • Up to Week 15
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/59 • Up to Week 15
|
1.9%
1/53 • Up to Week 15
|
|
Infections and infestations
Upper respiratory tract infection
|
1.7%
1/59 • Up to Week 15
|
1.9%
1/53 • Up to Week 15
|
|
Infections and infestations
Urinary tract infection
|
1.7%
1/59 • Up to Week 15
|
0.00%
0/53 • Up to Week 15
|
|
Infections and infestations
Vaginitis bacterial
|
0.00%
0/59 • Up to Week 15
|
1.9%
1/53 • Up to Week 15
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/59 • Up to Week 15
|
1.9%
1/53 • Up to Week 15
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/59 • Up to Week 15
|
1.9%
1/53 • Up to Week 15
|
|
Injury, poisoning and procedural complications
Inadequate analgesia
|
0.00%
0/59 • Up to Week 15
|
1.9%
1/53 • Up to Week 15
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/59 • Up to Week 15
|
1.9%
1/53 • Up to Week 15
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/59 • Up to Week 15
|
1.9%
1/53 • Up to Week 15
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
1.7%
1/59 • Up to Week 15
|
0.00%
0/53 • Up to Week 15
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/59 • Up to Week 15
|
1.9%
1/53 • Up to Week 15
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/59 • Up to Week 15
|
1.9%
1/53 • Up to Week 15
|
|
Investigations
Alanine aminotransferase increased
|
1.7%
1/59 • Up to Week 15
|
1.9%
1/53 • Up to Week 15
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/59 • Up to Week 15
|
1.9%
1/53 • Up to Week 15
|
|
Investigations
Blood glucose increased
|
0.00%
0/59 • Up to Week 15
|
1.9%
1/53 • Up to Week 15
|
|
Investigations
Blood urine present
|
1.7%
1/59 • Up to Week 15
|
1.9%
1/53 • Up to Week 15
|
|
Investigations
Liver function test abnormal
|
1.7%
1/59 • Up to Week 15
|
0.00%
0/53 • Up to Week 15
|
|
Investigations
Protein urine present
|
1.7%
1/59 • Up to Week 15
|
0.00%
0/53 • Up to Week 15
|
|
Investigations
Tandem galt test abnormal
|
1.7%
1/59 • Up to Week 15
|
0.00%
0/53 • Up to Week 15
|
|
Investigations
Weight increased
|
1.7%
1/59 • Up to Week 15
|
0.00%
0/53 • Up to Week 15
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.7%
1/59 • Up to Week 15
|
3.8%
2/53 • Up to Week 15
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/59 • Up to Week 15
|
1.9%
1/53 • Up to Week 15
|
|
Metabolism and nutrition disorders
Increased appetite
|
3.4%
2/59 • Up to Week 15
|
0.00%
0/53 • Up to Week 15
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.7%
1/59 • Up to Week 15
|
0.00%
0/53 • Up to Week 15
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.7%
1/59 • Up to Week 15
|
0.00%
0/53 • Up to Week 15
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.7%
1/59 • Up to Week 15
|
3.8%
2/53 • Up to Week 15
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/59 • Up to Week 15
|
1.9%
1/53 • Up to Week 15
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.8%
4/59 • Up to Week 15
|
0.00%
0/53 • Up to Week 15
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
3.4%
2/59 • Up to Week 15
|
0.00%
0/53 • Up to Week 15
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.4%
2/59 • Up to Week 15
|
0.00%
0/53 • Up to Week 15
|
|
Nervous system disorders
Ataxia
|
3.4%
2/59 • Up to Week 15
|
0.00%
0/53 • Up to Week 15
|
|
Nervous system disorders
Balance disorder
|
3.4%
2/59 • Up to Week 15
|
0.00%
0/53 • Up to Week 15
|
|
Nervous system disorders
Depressed level of consciousness
|
1.7%
1/59 • Up to Week 15
|
0.00%
0/53 • Up to Week 15
|
|
Nervous system disorders
Disturbance in attention
|
1.7%
1/59 • Up to Week 15
|
0.00%
0/53 • Up to Week 15
|
|
Nervous system disorders
Dizziness
|
6.8%
4/59 • Up to Week 15
|
0.00%
0/53 • Up to Week 15
|
|
Nervous system disorders
Dysarthria
|
5.1%
3/59 • Up to Week 15
|
0.00%
0/53 • Up to Week 15
|
|
Nervous system disorders
Headache
|
13.6%
8/59 • Up to Week 15
|
7.5%
4/53 • Up to Week 15
|
|
Nervous system disorders
Lethargy
|
3.4%
2/59 • Up to Week 15
|
1.9%
1/53 • Up to Week 15
|
|
Nervous system disorders
Migraine
|
1.7%
1/59 • Up to Week 15
|
0.00%
0/53 • Up to Week 15
|
|
Nervous system disorders
Motor dysfunction
|
1.7%
1/59 • Up to Week 15
|
0.00%
0/53 • Up to Week 15
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/59 • Up to Week 15
|
1.9%
1/53 • Up to Week 15
|
|
Nervous system disorders
Sedation
|
8.5%
5/59 • Up to Week 15
|
7.5%
4/53 • Up to Week 15
|
|
Nervous system disorders
Slow speech
|
0.00%
0/59 • Up to Week 15
|
1.9%
1/53 • Up to Week 15
|
|
Nervous system disorders
Somnolence
|
18.6%
11/59 • Up to Week 15
|
13.2%
7/53 • Up to Week 15
|
|
Nervous system disorders
Tremor
|
3.4%
2/59 • Up to Week 15
|
0.00%
0/53 • Up to Week 15
|
|
Psychiatric disorders
Abnormal dreams
|
1.7%
1/59 • Up to Week 15
|
0.00%
0/53 • Up to Week 15
|
|
Psychiatric disorders
Anger
|
1.7%
1/59 • Up to Week 15
|
0.00%
0/53 • Up to Week 15
|
|
Psychiatric disorders
Anorgasmia
|
1.7%
1/59 • Up to Week 15
|
0.00%
0/53 • Up to Week 15
|
|
Psychiatric disorders
Confusional state
|
5.1%
3/59 • Up to Week 15
|
0.00%
0/53 • Up to Week 15
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/59 • Up to Week 15
|
1.9%
1/53 • Up to Week 15
|
|
Psychiatric disorders
Depressed
|
1.7%
1/59 • Up to Week 15
|
0.00%
0/53 • Up to Week 15
|
|
Psychiatric disorders
Euphoric mood
|
1.7%
1/59 • Up to Week 15
|
0.00%
0/53 • Up to Week 15
|
|
Psychiatric disorders
Initial insomnia
|
1.7%
1/59 • Up to Week 15
|
0.00%
0/53 • Up to Week 15
|
|
Psychiatric disorders
Insomnia
|
3.4%
2/59 • Up to Week 15
|
3.8%
2/53 • Up to Week 15
|
|
Psychiatric disorders
Nightmare
|
6.8%
4/59 • Up to Week 15
|
0.00%
0/53 • Up to Week 15
|
|
Psychiatric disorders
Post-traumatic stress disorder
|
0.00%
0/59 • Up to Week 15
|
3.8%
2/53 • Up to Week 15
|
|
Psychiatric disorders
Psychomotor retardation
|
1.7%
1/59 • Up to Week 15
|
0.00%
0/53 • Up to Week 15
|
|
Psychiatric disorders
Sleep disorder
|
1.7%
1/59 • Up to Week 15
|
0.00%
0/53 • Up to Week 15
|
|
Psychiatric disorders
Suicidal ideation
|
1.7%
1/59 • Up to Week 15
|
1.9%
1/53 • Up to Week 15
|
Additional Information
Marinus Clinical Trials Submission Manager
Marinus Pharmaceuticals, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place