Study To Evaluate The Efficacy And Safety Of Balovaptan In Adults With Post-Traumatic Stress Disorder (PTSD)

Study Overview
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Brief Summary
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This study will evaluate the efficacy and safety of 10 mg of oral administration balovaptan once a day (QD) compared with matching placebo in adults with PTSD.

Official Title
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A Phase II, Randomized, Double-Blind, Placebo-Controlled, Two-Arm, Parallel-Group, Multicenter Study To Evaluate The Efficacy And Safety Of Balovaptan In Adults With Post-Traumatic Stress Disorder

Conditions
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Stress Disorders, Post-Traumatic

Intervention / Treatment
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* Drug: Balovaptan
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants who have a current diagnosis of PTSD as per DSM-5 criteria, with a score of >/=33 on the PCL-5 at screening The index trauma event must have occurred in adulthood, i.e., when the participant was >/=18 years old The index trauma event must have occurred at least 6 months prior to screening and no more than 10 years prior to screening At baseline, either taking a stable dose of a single antidepressant (SSRI or SNRI) for management of PTSD and have been on that medication for >/=6 weeks at that stable dosage and demonstrating residual symptoms of PTSD or prior demonstrated lack of tolerability or lack of efficacy and not taking an antidepressant medication at baseline for >/=6 weeks Treatment with permitted medications and/or non-pharmacological interventions at a stable dose for 6 weeks prior to screening For women of childbearing potential: agreement to remain abstinent or use contraception Exclusion Criteria: Participants who are experiencing ongoing exposure to traumatic events within 3 months of screening Participants who are pregnant or breastfeeding, or intending to become pregnant during the study or within 14 days after the final dose of study drug Clinically significant psychiatric and/or neurological conditions, which may interfere with the assessment of safety or efficacy endpoints Substance use disorders during last 12 months Significant risk for suicidal behaviour Epilepsy or seizure disorder considered not well controlled within the past 6 months or changes in anticonvulsive therapy within the last 6 months Clinical diagnosis of peripheral neuropathy Within the last 2 years, unstable or clinically significant cardiovascular disorders Positive serology results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) 1 or 2 Moderate or severe hepatic or renal impairment History of coagulopathies, bleeding disorders, blood dyscrasias, hematological malignancies, myelosuppression (including iatrogenic) Medical history of malignancy, if not considered cured Participants who have received treatment with investigational therapy within 8 weeks prior to randomization Known hypersensitivity to balovaptan, its components, or any of the excipients used in the formulation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Balovaptan<br> | Drug: Balovaptan<br>* Intervention of oral administration of 10mg balovaptan QD for 12 weeks followed by two weeks of follow-up period<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Matching placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the Clinician-Administered PTSD Total Symptom Severity Score | 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. | From Baseline up to Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in symptom severity as measured by Clinician-Global Impression of Severity (CGI-S) after 12 weeks of treatment | The CGI-S reflects the rater's impression of the subject's current PTSD severity on a 7-point scale ranging from no symptoms (1) to very severe symptoms (7). | From Baseline up to Week 12 | 
| Change from baseline at Week 12 in the Patient Health Questionnaire-9 (PHQ-9) total score | 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. | From Baseline up to Week 12 | 
| Percentage of participants with adverse events |  | From Baseline up to Week 12 |