Phase 2
Completed N=29
Study To Evaluate The Efficacy And Safety Of Balovaptan In Adults With Post-Traumatic Stress Disorder (PTSD)
Stress Disorders, Post-Traumatic
Source: ClinicalTrials.gov NCT05401565 ↗
Enrolled (actual)
29
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcomePrimary: Change From Baseline in the Clinician-Administered PTSD Total Symptom Severity Score — 35.5; 33.8; -6.8; -10.3 Score on a Scale
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Clinician-Administered PTSD Total Symptom Severity Score |
35.5; 33.8; -6.8; -10.3; -15.6; -17.2 | — |
| SECONDARY Symptom Severity as Measured by Clinician-Global Impression of Severity (CGI-S) Scale Score |
0; 0; 1; 0; 3; 8 | — |
| SECONDARY Change From Baseline at Week 12 in the Patient Health Questionnaire-9 (PHQ-9) Total Score |
15.2; 12.2; -2.7; -2.5; -6.0; -3.5 | — |
| SECONDARY Percentage of Participants With Adverse Events |
7; 9 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05401565). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.