Efficacy and Safety of HB-1 for Panic Disorder
PHASE2TERMINATED
The purpose of this study is to determine the safety and efficacy of HB-1, versus placebo and two monotherapies, in male and female adult patients aged 18 to 65 years, inclusive, with Panic Disorder.
Study details:
This is a multicenter, randomized, double-blind, placebo-controlled trial. All patients with Panic Disorder, with or without specified co-morbidities, who meet all of the inclusion and none of the exclusion criteria will be eligible. Patients and researchers will be blinded to their treatment group.
The study will enroll approximately 240 (up to 600) adult patients who meet the diagnosis of panic disorder. Patients will be treated for 12 weeks followed by a safety follow up visit one week after their last dose of study treatment.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
- Male or female aged 18 to 65 years old, inclusive, at the time of informed consent.
- Meets Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-V) Criteria for Panic Disorder.
- Minimum of one full, unexpected panic attack in week prior to screening (via Diagnostic and Statistical Manual of Mental Disorders 5th edition [DSM-V] based structured interview).
- Medically stable on current medication regimen for at least 3 months (including as needed [PRN] medications), as determined by Investigator.
- Willing to remain on current doses of other psychiatric medications throughout the length of the trial.
- Willing and able to safely stop / avoid any of the following prior to study trial: Inhibitors or inducers of CYP3A4 (grapefruit juice, erythromycin, ritonavir, telithromycin, rifampin), HMG-CoA Reductase Inhibitors (Simvastatin, Lovastatin, Atorvastatin), Beta Blockers (Timolol eyedrops, Metoprolol), Neuromuscular Blocking Agents (curare-like and depolarizing), Antihypertensive Agents (Prazosin and vasodilators, angiotensin-converting enzyme inhibitors, diuretics, beta blockers), Inhalation Anesthetics, Disopyramide, Flecainide, Quinidine, Cimetidine, Lithium, Carbamazepine, Phenobarbital, Cyclosporine, Digitalis, Aliskiren, Ramipril and Ramiprilat, aspirin, propranolol.
- Willing and able to safely stop / avoid sensitive P-glycoprotein inhibitors.
- Willing to take HB-1, telmisartan, verapamil, or placebo.
- Willing and able to provide informed consent indicating an understanding of the requirements of the study and a willingness to comply with scheduled visits and all study procedures.
- Female subjects must be surgically sterile (or have a monogamous partner who is surgically sterile) or be at least 2 years postmenopausal or commit to use 2 acceptable forms of birth control (defined as the use of an intrauterine device, a barrier method with spermicide, condoms, any form of hormonal contraceptives, or abstinence) for the duration of the study and for 4 months following the last dose of study treatment. Male subjects must be sterile (biologically or surgically) or commit to the use of a reliable method of birth control (condoms ± spermicide) for the duration of the study and for 4 months following the last dose of study treatment. Individuals who are involved exclusively in same-sex relationships are exempt from the birth control requirements but must agree to abide by the recommendations if they do engage in a heterosexual relationship.
- Female subjects who are women of childbearing potential (WOCBP) must have a negative pregnancy test at Screening, within 7 days of dosing with study treatment.
Exclusion criteria
- Any 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.
- Concurrent treatment with benzodiazepines (e.g. alprazolam, diazepam, clonazepam, lorazepam) as assessed by clinical interview and urine toxicology testing.
- Severe Agoraphobia (Panic Disorder Symptom Severity Scale (PDSS) Item 4 "agoraphobic fear/avoidance" > 2).
- Severe Generalized Anxiety (Hamilton Anxiety Rating Scale [HAM-A] Total Score > 23).
- Prior lifetime history of suicide attempt, Columbia Suicide Severity Rating Scale (C-SSRS) ≥ 4 in the past 6 months or prior lifetime history of hospitalization for depression.
- Diagnosis of Substance Use Disorder, Obsessive-Compulsive Disorder (OCD), Bipolar I, Bipolar II disorder or schizoaffective or other psychotic disorders (per Structure Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-V) [SCID-V].
- Severe uncontrolled cardiac disease within 6 months of Screening, including but not limited to uncontrolled hypertension, hypotension (defined as below 90/60); unstable angina; myocardial infarction (MI) or cerebrovascular accident (CVA).
- Any clinically significant electrocardiogram (ECG) abnormalities at screening.
- Inadequate hepatic function defined as total bilirubin > 1.5 × the upper limit of normal (ULN) ranges of each institution, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 3 × the ULN range of each institution.
- Inadequate renal function defined as serum creatinine > 1.5 × the upper limit of normal (ULN) range of each institution and/or estimated glomerular filtration rate (eGFR) < 60.
- Any clinically significant abnormalities in clinical laboratory assessments as assessed by the Investigator.
- Any other systemic conditions or organ abnormalities that in the opinion of the Investigator may interfere with the conduct and/or interpretation of the current study.
- Unable to complete neuropsychological testing.
- Already on treatment with either telmisartan or verapamil or both.
- Has a history of hypersensitivity or severe allergic reaction to either telmisartan or verapamil, or any component of either licensed drug.
- Documented contraindication to taking telmisartan or verapamil: (e.g., Duchenne's muscular dystrophy, myasthenia gravis).
- Pregnant or breastfeeding.
- Participation in another current clinical trial or prior trial within the last three months.
- Urinalysis evidence of exposure to substances that may interfere with HB-1 testing (per investigator discretion).
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
TREATMENT
Phase
- PHASE2
Study ID
NCT06483789
Intervention or treatment
DRUG: HB-1
DRUG: Telmisartan Only Product in Oral Dose Form
DRUG: Verapamil Only Product in Oral Dose Form
DRUG: Placebo
Conditions
- Panic Disorder
- Mental Illness
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Research sites nearby
Closest Location:
Paratus Clinical Research Canberra
Select from list below to view details:
Paratus Clinical Research Canberra
Canberra, Australian Capital Territory, Australia
Paratus Clinical Research Western Sydney
Blacktown, New South Wales, Australia
East Sydney Doctors
Darlinghurst, New South Wales, Australia
Momentum Clinical Research Darlinghurst
Darlinghurst, New South Wales, Australia
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Who is running the clinical trial?
HBL
Honeybrains Biotech LLC
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: HB-1
| Drug: HB-1 |
EXPERIMENTAL: Telmisartan
| Drug: Telmisartan Only Product in Oral Dose Form |
EXPERIMENTAL: Verapamil
| Drug: Verapamil Only Product in Oral Dose Form |
PLACEBO_COMPARATOR: Placebo
| Drug: Placebo |
What is the study measuring?
Primary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Number of Unexpected Panic Attacks | Efficacy will be evaluated through a comparison of the number of unexpected panic attacks from Screening as compared to protocol-specified timepoints per protocol. | Screening, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, and Week 12 |
| Incidence of Treatment-Emergent Adverse Events | Safety will be evaluated through the monitoring of Adverse Events and the review of clinically significant changes in routine laboratory tests, ECGs, and orthostatic vital signs. | Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12 and Week 13. |
Secondary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Change in Clinical Global Impression-Severity Scale (CGI-S) | Efficacy will be evaluated through an evaluation in Clinical Global Impression Severity scale (CGI-S) scores from Baseline as compared to protocol-specified timepoints per protocol. The Clinical Global Impression Severity Scale is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients). | Baseline, Week 4, Week 8 and Week 12 |
| Change in Panic Disorder Symptom Severity Scale (PDSS) | Efficacy will be evaluated through an evaluation in Panic Disorder Symptom Severity Scale (PDSS) scores from Screening as compared to protocol-specified timepoints per protocol. | Screening, Week 4, Week 8 and Week 12 |
Are you running this trial?If you're a clinic or sponsor, you can claim this study.
References
Clinical Trials Gov: Efficacy and Safety of HB-1 for Panic DisorderOther trials to consider
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