Study To Evaluate The Efficacy And Safety Of Balovaptan In Adults With Post-Traumatic Stress Disorder (PTSD)
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Balovaptan
|
Drug: Balovaptan
Intervention of oral administration of 10mg balovaptan QD for 12 weeks followed by two weeks of follow-up period
|
| Placebo Comparator: Placebo
|
Drug: Placebo
Matching placebo
|
Outcome Measures
Primary Outcome Measures
- Change from baseline in the Clinician-Administered PTSD Total Symptom Severity Score [From Baseline up to Week 12]
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.
Secondary Outcome Measures
- Change from baseline in symptom severity as measured by Clinician-Global Impression of Severity (CGI-S) after 12 weeks of treatment [From Baseline up to Week 12]
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).
- Change from baseline at Week 12 in the Patient Health Questionnaire-9 (PHQ-9) total score [From Baseline up to Week 12]
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.
- Percentage of participants with adverse events [From Baseline up to Week 12]
Eligibility Criteria
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
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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
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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
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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
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Clinically significant psychiatric and/or neurological conditions, which may interfere with the assessment of safety or efficacy endpoints
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Substance use disorders during last 12 months
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Significant risk for suicidal behaviour
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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
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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
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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
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | American Medical Research, Inc | Oak Brook | Illinois | United States | 60523 |
| 2 | Coastal Carolina Research Center | Mount Pleasant | South Carolina | United States | 29464 |
Sponsors and Collaborators
- Hoffmann-La Roche
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BN43546