Safety and Efficacy of HB-1 for Post-Traumatic Stress Disorder
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorHB BioTech, LLC
About this trial
The purpose of this study is to determine the safety and efficacy of HB-1, versus placebo in male and female adult patients aged 18 to 65 years, inclusive, with Post-Traumatic Stress Disorder (PTSD).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female aged 18 to 65 years old, inclusive, at the time of informed consent.
Meets DSM-V Criteria for PTSD.
Minimum CAPS-5 score of at least 26 (based on the optimal diagnostic correspondence in the definitive CAPS-5 psychometric validation study).
Clinically stable on current medication and/or therapy regimen for at least 2 months, as determined by Investigator.
Disqualifiers
Any ongoing concomitant disease, condition, or treatment that could interfere with the conduct of the study, or that would, in the opinion of the Investigator or Sponsor, pose an unacceptable risk to the participant in the study or interfere with the interpretation of study data.
Ongoing treatment with benzodiazepines (e.g. alprazolam, diazepam, clonazepam, lorazepam) or opiates (e.g., codeine, morphine) as assessed by clinical interview and urine toxicology testing.
Ongoing treatment with any medication that has a clinically significant drug-drug interaction with either telmisartan or verapamil, per the verapamil SR and telmisartan FDA labels and per standard drug interaction compendia. These include but are not limited to: Inhibitors or inducers of cytochrome P450 (CYP)3A4 (including certain β-hydroxy β-methylglutaryl-CoA [HMG-CoA] reductase inhibitors), Ivabradine, Antihypertensive Agents (including Beta Blockers), Antiarrhythmic Agents, Lithium, Carbamazepine, Rifampin, Phenobarbital, cyclosporin, theophylline, Inhalation Anesthetics, Neuromuscular Blocking Agents, Telithromycin, mTOR inhibitors as well as strong P-glycoprotein inhibitors (e.g., macrolides, ritonavir, itraconazole, ketoconazole, cyclosporin, ritonavir, and ivermectin).
Diagnosis of Severe Substance Use Disorder, Obsessive-Compulsive Disorder (OCD), Bipolar I, Bipolar II disorder, or Psychotic disorder (per SCID-V) or Borderline Personality Disorder (per Short-Bord).
Trial design
Design model
Parallel
Treatments tested in this trial
HB-1
DrugHB-1 will be supplied as a dual active pharmaceutical ingredient tablet. The two HB-1 doses for this study include 64/192 and 86/258 telmisartan/verapamil extended release, using unique bi-layer tablets. All subjects randomized to receive HB-1 will begin with the 64/192mg dose taken as one tablet once per day. At each monthly visit, treatment tolerance and response will be adjudicated using objective, dose-escalation criteria. At both Week 4 and Week 8, all subjects will be evaluated for dose escalation. Subjects who are demonstrating a reduction of 50% or more in CAPS-5 total score will remain in treatment with HB-1 (or Placebo) at same dose. Subjects with less than a 50% reduction in CAPS-5, who have experienced no treatment-emergent Grade 3 or higher adverse event related to study drug since the prior visit, will be dose-escalated to the 86/258mg telmisartan/verapamil extended dose. After escalation, subjects will remain on higher dose throughout the remainder of the study.
Placebo
DrugMatching Placebo will be dispensed to analogous subjects in Placebo group.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: HB-1Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
To measure the efficacy of HB-1 on clinician-rated symptoms of Post-Traumatic Stress Disorder in male and female adults (age 18 to 65 years) with Post-Traumatic Stress Disorder.
Change from Baseline to Week 12 in Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) (CAPS-5), Past Month Version. The 5 point Clinician-Administered PTSD Scale-5 symptom severity scale is used for all Post-Traumatic Stress Disorder symptoms. The scale has a minimum score of zero (Absent), One (Mild), Two (Moderate), Three (Severe) and Four (Extreme) (the maximum score is 4). Higher score indicates a worse outcome.
Time frame
Baseline, Week 4, Week 8 and Week 12.Secondary outcomes
1
To measure the efficacy of HB-1 on clinical global impression (CGI) and other clinically accepted, Post-Traumatic Stress Disorder (PTSD)-related outcome measures in male and female adults (age 18 to 65 years) with PTSD.
Change from Baseline to Week 12 in Clinical Global Impression-Severity Scale (CGI-S). The 8 point Clinical Global Impression-Severity Scale (CGI-S) has a minimum score of Zero (Not assessed), One (Normal, not ill at all), Two (Borderline ill), Three (Mildly ill), Four (Moderately ill), Five (Markedly ill), Six (Severely ill) and Seven (Among the most extremely ill patients) (the maximum score is 7). Higher score indicates a worse outcome.
Time frame
From enrolment to the end of treatment at 12 weeks. Baseline, Week 4, Week 8 and Week 12.2
To measure the efficacy of HB-1 on clinically accepted Perceived Stress Scale (PSS), Post-Traumatic Stress Disorder (PTSD)-related outcome measures in male and female adults (age 18 to 65 years) with PTSD.
Change from baseline to Week 12 in Perceived Stress Scale (PSS). The 5 point Perceived Stress Scale (PSS) has a minimum score of Zero (Never), One (Almost never), Two (Sometimes), Three (Fairly often) and Four (Very often) (the maximum score is 4). Higher score indicates a worse outcome.
Time frame
Baseline, Week 4, Week 8 and Week 12.3
To measure the efficacy of HB-1 on clinically accepted Brief Symptom Inventory (BSI), PTSD-related outcome measures in male and female adults (age 18 to 65 years) with PTSD.
Change from baseline to Week 12 in Brief Symptom Inventory (BSI). The scale has a minimum score of Zero (Not at all), plus other scores including One (A little bit), Two (Moderately), Three (Quite a bit) and 4 (Extremely) (the maximum score is 4). Higher score indicates a worse outcome.
Time frame
Baseline, Week 4, Week 8 and Week 12.4
To measure the efficacy of HB-1 on clinically accepted Patient Global Impression-Severity Scale, Post-Traumatic Stress Disorder (PTSD)-related outcome measures in male and female adults (age 18 to 65 years) with PTSD.
Change from baseline to Week 12 in Patient Global Impression-Severity Scale (PGI-S). Scale ranges from None, Mild, Moderate, Severe and Very Severe.
Time frame
Baseline, Week 4, Week 8 and Week 12.Sponsors and contacts
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Source ClinicalTrials.gov