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

Primary Purpose

Stress Disorders, Post-Traumatic

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Balovaptan
Placebo
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Disorders, Post-Traumatic

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Alea Research
  • CITrials, Inc.
  • ASCLEPES Research Centers
  • Clinical Innovations, Inc
  • Sarkis Clinical Trials
  • Galiz Research, LLC
  • Florida International Research Center
  • American Medical Research, Inc
  • Boston Clinical Trials & Medical Research
  • Michigan Clinical Research Institute PC - Clinedge - PPDS
  • Va Medical Center
  • Alivation Research, LLC
  • Bioscience Research, LLC
  • Coastal Carolina Research Center
  • Donald J. Garcia Jr., MD, PA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Balovaptan

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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.
Percentage of participants with adverse events

Full Information

First Posted
May 29, 2022
Last Updated
September 3, 2023
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT05401565
Brief Title
Study To Evaluate The Efficacy And Safety Of Balovaptan In Adults With Post-Traumatic Stress Disorder (PTSD)
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 2, 2022 (Actual)
Primary Completion Date
December 15, 2023 (Anticipated)
Study Completion Date
December 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Disorders, Post-Traumatic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Balovaptan
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Balovaptan
Intervention Description
Intervention of oral administration of 10mg balovaptan QD for 12 weeks followed by two weeks of follow-up period
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo
Primary Outcome Measure Information:
Title
Change from baseline in the Clinician-Administered PTSD Total Symptom Severity Score
Description
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.
Time Frame
From Baseline up to Week 12
Secondary Outcome Measure Information:
Title
Change from baseline in symptom severity as measured by Clinician-Global Impression of Severity (CGI-S) after 12 weeks of treatment
Description
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).
Time Frame
From Baseline up to Week 12
Title
Change from baseline at Week 12 in the Patient Health Questionnaire-9 (PHQ-9) total score
Description
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.
Time Frame
From Baseline up to Week 12
Title
Percentage of participants with adverse events
Time Frame
From Baseline up to Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Alea Research
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
Facility Name
CITrials, Inc.
City
Bellflower
State/Province
California
ZIP/Postal Code
90706
Country
United States
Facility Name
ASCLEPES Research Centers
City
Panorama City
State/Province
California
ZIP/Postal Code
91402
Country
United States
Facility Name
Clinical Innovations, Inc
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
Sarkis Clinical Trials
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Facility Name
Galiz Research, LLC
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Florida International Research Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
American Medical Research, Inc
City
Oak Brook
State/Province
Illinois
ZIP/Postal Code
60523
Country
United States
Facility Name
Boston Clinical Trials & Medical Research
City
Roslindale
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
Facility Name
Michigan Clinical Research Institute PC - Clinedge - PPDS
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States
Facility Name
Va Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417
Country
United States
Facility Name
Alivation Research, LLC
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68526
Country
United States
Facility Name
Bioscience Research, LLC
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Coastal Carolina Research Center
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Donald J. Garcia Jr., MD, PA
City
Austin
State/Province
Texas
ZIP/Postal Code
78737
Country
United States

12. IPD Sharing Statement

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

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