Trial Outcomes & Findings for Study To Evaluate The Efficacy And Safety Of Balovaptan In Adults With Post-Traumatic Stress Disorder (PTSD) (NCT NCT05401565)
NCT ID: NCT05401565
Last Updated: 2024-04-18
Results Overview
The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) measures the severity of PTSD where smaller scores indicate less severe PTSD and higher scores suggest more severe PTSD. Possible scores for this 30 item version range from 0 to 120. Measured 3 times over 12 weeks.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
29 participants
Primary outcome timeframe
From Baseline up to Week 12
Results posted on
2024-04-18
Participant Flow
More participants (29) were enrolled than initially planned (16)
Participant milestones
| Measure |
Placebo
Matching placebo
|
Balovaptan
Intervention of oral administration of 10mg balovaptan QD for 12 weeks followed by two weeks of follow-up period
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
13
|
|
Overall Study
COMPLETED
|
13
|
13
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
| Measure |
Placebo
Matching placebo
|
Balovaptan
Intervention of oral administration of 10mg balovaptan QD for 12 weeks followed by two weeks of follow-up period
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Adverse Event
|
2
|
0
|
Baseline Characteristics
Study To Evaluate The Efficacy And Safety Of Balovaptan In Adults With Post-Traumatic Stress Disorder (PTSD)
Baseline characteristics by cohort
| Measure |
Placebo
n=16 Participants
Matching placebo
|
Balovaptan
n=13 Participants
Intervention of oral administration of 10mg balovaptan QD for 12 weeks followed by two weeks of follow-up period
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36.6 Years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
38.2 Years
STANDARD_DEVIATION 13.8 • n=7 Participants
|
37.3 Years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
23 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
|
PRIMARY outcome
Timeframe: From Baseline up to Week 12Population: ITT Population
The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) measures the severity of PTSD where smaller scores indicate less severe PTSD and higher scores suggest more severe PTSD. Possible scores for this 30 item version range from 0 to 120. Measured 3 times over 12 weeks.
Outcome measures
| Measure |
Placebo
n=16 Participants
Matching placebo
|
Balovaptan
n=13 Participants
Intervention of oral administration of 10mg balovaptan QD for 12 weeks followed by two weeks of follow-up period
|
|---|---|---|
|
Change From Baseline in the Clinician-Administered PTSD Total Symptom Severity Score
Baseline
|
35.5 Score on a Scale
Standard Deviation 9.3
|
33.8 Score on a Scale
Standard Deviation 7.8
|
|
Change From Baseline in the Clinician-Administered PTSD Total Symptom Severity Score
Week 6
|
-6.8 Score on a Scale
Standard Deviation 11.2
|
-10.3 Score on a Scale
Standard Deviation 9.2
|
|
Change From Baseline in the Clinician-Administered PTSD Total Symptom Severity Score
Week 12
|
-15.6 Score on a Scale
Standard Deviation 10.6
|
-17.2 Score on a Scale
Standard Deviation 10.7
|
SECONDARY outcome
Timeframe: From Baseline up to Week 12Population: ITT Population
The CGI-S reflects the rater's impression of the subject's current PTSD severity on a 6-point scale ranging from no symptoms (1) to very severe symptoms (6).
Outcome measures
| Measure |
Placebo
n=16 Participants
Matching placebo
|
Balovaptan
n=13 Participants
Intervention of oral administration of 10mg balovaptan QD for 12 weeks followed by two weeks of follow-up period
|
|---|---|---|
|
Symptom Severity as Measured by Clinician-Global Impression of Severity (CGI-S) Scale Score
Baseline Very mild
|
0 Participants
|
0 Participants
|
|
Symptom Severity as Measured by Clinician-Global Impression of Severity (CGI-S) Scale Score
Baseline Mild
|
1 Participants
|
0 Participants
|
|
Symptom Severity as Measured by Clinician-Global Impression of Severity (CGI-S) Scale Score
Baseline Moderate
|
3 Participants
|
8 Participants
|
|
Symptom Severity as Measured by Clinician-Global Impression of Severity (CGI-S) Scale Score
Baseline Severe
|
11 Participants
|
5 Participants
|
|
Symptom Severity as Measured by Clinician-Global Impression of Severity (CGI-S) Scale Score
Baseline Very severe
|
0 Participants
|
0 Participants
|
|
Symptom Severity as Measured by Clinician-Global Impression of Severity (CGI-S) Scale Score
Week 6 Very mild
|
0 Participants
|
0 Participants
|
|
Symptom Severity as Measured by Clinician-Global Impression of Severity (CGI-S) Scale Score
Week 6 Mild
|
0 Participants
|
4 Participants
|
|
Symptom Severity as Measured by Clinician-Global Impression of Severity (CGI-S) Scale Score
Week 6 Moderate
|
4 Participants
|
8 Participants
|
|
Symptom Severity as Measured by Clinician-Global Impression of Severity (CGI-S) Scale Score
Week 6 Severe
|
8 Participants
|
1 Participants
|
|
Symptom Severity as Measured by Clinician-Global Impression of Severity (CGI-S) Scale Score
Week 6 Very severe
|
0 Participants
|
0 Participants
|
|
Symptom Severity as Measured by Clinician-Global Impression of Severity (CGI-S) Scale Score
Week 12 No Symptoms
|
2 Participants
|
0 Participants
|
|
Symptom Severity as Measured by Clinician-Global Impression of Severity (CGI-S) Scale Score
Week 12 Very mild
|
0 Participants
|
1 Participants
|
|
Symptom Severity as Measured by Clinician-Global Impression of Severity (CGI-S) Scale Score
Week 12 Mild
|
3 Participants
|
6 Participants
|
|
Symptom Severity as Measured by Clinician-Global Impression of Severity (CGI-S) Scale Score
Week 12 Moderate
|
5 Participants
|
5 Participants
|
|
Symptom Severity as Measured by Clinician-Global Impression of Severity (CGI-S) Scale Score
Week 12 Severe
|
3 Participants
|
1 Participants
|
|
Symptom Severity as Measured by Clinician-Global Impression of Severity (CGI-S) Scale Score
Week 12 Very severe
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Baseline up to Week 12Population: ITT Population
PHQ-9 is a 9-item PRO used to assess severity of depression. Responses are rated based on frequency of symptoms on a 4-point Likert scale, ranging from 0 (not at all) to 3 (nearly every day). A total PHQ-9 total score ranging from 0 to 27 can be calculated by summing the nine items, of which a higher score corresponds to more severe depression.
Outcome measures
| Measure |
Placebo
n=16 Participants
Matching placebo
|
Balovaptan
n=13 Participants
Intervention of oral administration of 10mg balovaptan QD for 12 weeks followed by two weeks of follow-up period
|
|---|---|---|
|
Change From Baseline at Week 12 in the Patient Health Questionnaire-9 (PHQ-9) Total Score
Baseline
|
15.2 Score on a Scale
Standard Deviation 4.8
|
12.2 Score on a Scale
Standard Deviation 5.1
|
|
Change From Baseline at Week 12 in the Patient Health Questionnaire-9 (PHQ-9) Total Score
Week 6
|
-2.7 Score on a Scale
Standard Deviation 5.6
|
-2.5 Score on a Scale
Standard Deviation 5.8
|
|
Change From Baseline at Week 12 in the Patient Health Questionnaire-9 (PHQ-9) Total Score
Week 12
|
-6.0 Score on a Scale
Standard Deviation 5.1
|
-3.5 Score on a Scale
Standard Deviation 5.2
|
SECONDARY outcome
Timeframe: From Baseline up to Week 12Population: Safety Population
Outcome measures
| Measure |
Placebo
n=16 Participants
Matching placebo
|
Balovaptan
n=13 Participants
Intervention of oral administration of 10mg balovaptan QD for 12 weeks followed by two weeks of follow-up period
|
|---|---|---|
|
Percentage of Participants With Adverse Events
|
7 Participants
|
9 Participants
|
Adverse Events
PLACEBO
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
BALOVAPTAN 10 MG
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PLACEBO
n=16 participants at risk
Matching placebo
|
BALOVAPTAN 10 MG
n=13 participants at risk
ntervention of oral administration of 10mg balovaptan QD for 12 weeks followed by two weeks of follow-up period
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/16 • Up To 12 Weeks
|
0.00%
0/13 • Up To 12 Weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/16 • Up To 12 Weeks
|
0.00%
0/13 • Up To 12 Weeks
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/16 • Up To 12 Weeks
|
0.00%
0/13 • Up To 12 Weeks
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/16 • Up To 12 Weeks
|
0.00%
0/13 • Up To 12 Weeks
|
|
Infections and infestations
COVID-19
|
0.00%
0/16 • Up To 12 Weeks
|
0.00%
0/13 • Up To 12 Weeks
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/16 • Up To 12 Weeks
|
0.00%
0/13 • Up To 12 Weeks
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/16 • Up To 12 Weeks
|
0.00%
0/13 • Up To 12 Weeks
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/16 • Up To 12 Weeks
|
0.00%
0/13 • Up To 12 Weeks
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/16 • Up To 12 Weeks
|
0.00%
0/13 • Up To 12 Weeks
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/16 • Up To 12 Weeks
|
0.00%
0/13 • Up To 12 Weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/16 • Up To 12 Weeks
|
0.00%
0/13 • Up To 12 Weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/16 • Up To 12 Weeks
|
0.00%
0/13 • Up To 12 Weeks
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/16 • Up To 12 Weeks
|
0.00%
0/13 • Up To 12 Weeks
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/16 • Up To 12 Weeks
|
0.00%
0/13 • Up To 12 Weeks
|
|
Nervous system disorders
Dizziness
|
0.00%
0/16 • Up To 12 Weeks
|
0.00%
0/13 • Up To 12 Weeks
|
|
Nervous system disorders
Headache
|
0.00%
0/16 • Up To 12 Weeks
|
0.00%
0/13 • Up To 12 Weeks
|
|
Nervous system disorders
Muscle contractions involuntary
|
0.00%
0/16 • Up To 12 Weeks
|
0.00%
0/13 • Up To 12 Weeks
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/16 • Up To 12 Weeks
|
0.00%
0/13 • Up To 12 Weeks
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/16 • Up To 12 Weeks
|
0.00%
0/13 • Up To 12 Weeks
|
|
Psychiatric disorders
Agitation
|
0.00%
0/16 • Up To 12 Weeks
|
0.00%
0/13 • Up To 12 Weeks
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/16 • Up To 12 Weeks
|
0.00%
0/13 • Up To 12 Weeks
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/16 • Up To 12 Weeks
|
0.00%
0/13 • Up To 12 Weeks
|
|
Psychiatric disorders
Libido decreased
|
0.00%
0/16 • Up To 12 Weeks
|
0.00%
0/13 • Up To 12 Weeks
|
|
Psychiatric disorders
Mood swings
|
0.00%
0/16 • Up To 12 Weeks
|
0.00%
0/13 • Up To 12 Weeks
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/16 • Up To 12 Weeks
|
0.00%
0/13 • Up To 12 Weeks
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/16 • Up To 12 Weeks
|
0.00%
0/13 • Up To 12 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/16 • Up To 12 Weeks
|
0.00%
0/13 • Up To 12 Weeks
|
Other adverse events
| Measure |
PLACEBO
n=16 participants at risk
Matching placebo
|
BALOVAPTAN 10 MG
n=13 participants at risk
ntervention of oral administration of 10mg balovaptan QD for 12 weeks followed by two weeks of follow-up period
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/16 • Up To 12 Weeks
|
7.7%
1/13 • Number of events 1 • Up To 12 Weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
6.2%
1/16 • Number of events 1 • Up To 12 Weeks
|
0.00%
0/13 • Up To 12 Weeks
|
|
Gastrointestinal disorders
Nausea
|
6.2%
1/16 • Number of events 1 • Up To 12 Weeks
|
7.7%
1/13 • Number of events 1 • Up To 12 Weeks
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/16 • Up To 12 Weeks
|
7.7%
1/13 • Number of events 1 • Up To 12 Weeks
|
|
Infections and infestations
COVID-19
|
0.00%
0/16 • Up To 12 Weeks
|
7.7%
1/13 • Number of events 1 • Up To 12 Weeks
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/16 • Up To 12 Weeks
|
7.7%
1/13 • Number of events 1 • Up To 12 Weeks
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/16 • Up To 12 Weeks
|
7.7%
1/13 • Number of events 1 • Up To 12 Weeks
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/16 • Up To 12 Weeks
|
15.4%
2/13 • Number of events 2 • Up To 12 Weeks
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/16 • Up To 12 Weeks
|
7.7%
1/13 • Number of events 1 • Up To 12 Weeks
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/16 • Up To 12 Weeks
|
7.7%
1/13 • Number of events 1 • Up To 12 Weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.2%
1/16 • Number of events 1 • Up To 12 Weeks
|
0.00%
0/13 • Up To 12 Weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.2%
1/16 • Number of events 1 • Up To 12 Weeks
|
0.00%
0/13 • Up To 12 Weeks
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/16 • Up To 12 Weeks
|
7.7%
1/13 • Number of events 1 • Up To 12 Weeks
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
6.2%
1/16 • Number of events 1 • Up To 12 Weeks
|
0.00%
0/13 • Up To 12 Weeks
|
|
Nervous system disorders
Dizziness
|
0.00%
0/16 • Up To 12 Weeks
|
7.7%
1/13 • Number of events 1 • Up To 12 Weeks
|
|
Nervous system disorders
Headache
|
18.8%
3/16 • Number of events 3 • Up To 12 Weeks
|
7.7%
1/13 • Number of events 1 • Up To 12 Weeks
|
|
Nervous system disorders
Muscle contractions involuntary
|
6.2%
1/16 • Number of events 1 • Up To 12 Weeks
|
0.00%
0/13 • Up To 12 Weeks
|
|
Nervous system disorders
Neuropathy peripheral
|
6.2%
1/16 • Number of events 1 • Up To 12 Weeks
|
0.00%
0/13 • Up To 12 Weeks
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/16 • Up To 12 Weeks
|
7.7%
1/13 • Number of events 1 • Up To 12 Weeks
|
|
Psychiatric disorders
Agitation
|
6.2%
1/16 • Number of events 1 • Up To 12 Weeks
|
0.00%
0/13 • Up To 12 Weeks
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/16 • Up To 12 Weeks
|
7.7%
1/13 • Number of events 1 • Up To 12 Weeks
|
|
Psychiatric disorders
Insomnia
|
6.2%
1/16 • Number of events 1 • Up To 12 Weeks
|
0.00%
0/13 • Up To 12 Weeks
|
|
Psychiatric disorders
Libido decreased
|
6.2%
1/16 • Number of events 1 • Up To 12 Weeks
|
0.00%
0/13 • Up To 12 Weeks
|
|
Psychiatric disorders
Mood swings
|
6.2%
1/16 • Number of events 1 • Up To 12 Weeks
|
0.00%
0/13 • Up To 12 Weeks
|
|
Psychiatric disorders
Suicidal ideation
|
6.2%
1/16 • Number of events 1 • Up To 12 Weeks
|
0.00%
0/13 • Up To 12 Weeks
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/16 • Up To 12 Weeks
|
7.7%
1/13 • Number of events 1 • Up To 12 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.2%
1/16 • Number of events 1 • Up To 12 Weeks
|
0.00%
0/13 • Up To 12 Weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER