Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
240 participants
INTERVENTIONAL
2024-10-29
2027-02-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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HB-1
HB-1 fixed dose, once daily.
HB-1
HB-1 will be supplied as a dual active pharmaceutical ingredient tablet.
Telmisartan
Telmisartan fixed dose, once daily.
Telmisartan Only Product in Oral Dose Form
Telmisartan will be supplied as a single active pharmaceutical ingredient tablet.
Verapamil
Verapamil fixed dose, once daily.
Verapamil Only Product in Oral Dose Form
Verapamil will be supplied as a single active pharmaceutical ingredient tablet.
Placebo
Placebo treatment, once daily
Placebo
Matched Placebo will be supplied as a tablet.
Interventions
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HB-1
HB-1 will be supplied as a dual active pharmaceutical ingredient tablet.
Telmisartan Only Product in Oral Dose Form
Telmisartan will be supplied as a single active pharmaceutical ingredient tablet.
Verapamil Only Product in Oral Dose Form
Verapamil will be supplied as a single active pharmaceutical ingredient tablet.
Placebo
Matched Placebo will be supplied as a tablet.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Meets Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-V) Criteria for Panic Disorder.
3. 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).
4. Medically stable on current medication regimen for at least 3 months (including as needed \[PRN\] medications), as determined by Investigator.
5. Willing to remain on current doses of other psychiatric medications throughout the length of the trial.
6. 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.
7. Willing and able to safely stop / avoid sensitive P-glycoprotein inhibitors.
8. Willing to take HB-1, telmisartan, verapamil, or placebo.
9. 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.
10. 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.
11. 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
2. Concurrent treatment with benzodiazepines (e.g. alprazolam, diazepam, clonazepam, lorazepam) as assessed by clinical interview and urine toxicology testing.
3. Severe Agoraphobia (Panic Disorder Symptom Severity Scale (PDSS) Item 4 "agoraphobic fear/avoidance" \> 2).
4. Severe Generalized Anxiety (Hamilton Anxiety Rating Scale \[HAM-A\] Total Score \> 23).
5. 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.
6. 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) \[SCID-V\].
7. 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).
8. Any clinically significant electrocardiogram (ECG) abnormalities at screening.
9. 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.
10. 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.
11. Any clinically significant abnormalities in clinical laboratory assessments as assessed by the Investigator.
12. 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.
13. Unable to complete neuropsychological testing.
14. Already on treatment with either telmisartan or verapamil or both.
15. Has a history of hypersensitivity or severe allergic reaction to either telmisartan or verapamil, or any component of either licensed drug.
16. Documented contraindication to taking telmisartan or verapamil: (e.g., Duchenne's muscular dystrophy, myasthenia gravis).
17. Pregnant or breastfeeding.
18. Participation in another current clinical trial or prior trial within the last three months.
19. Urinalysis evidence of exposure to substances that may interfere with HB-1 testing (per investigator discretion).
18 Years
65 Years
ALL
No
Sponsors
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Honeybrains Biotech LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Prof. Malcolm Hopwood
Role: PRINCIPAL_INVESTIGATOR
Ramsay Clinic Albert Road
Locations
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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
Paratus Clinical Research Central Coast
Kanwal, New South Wales, Australia
Novatrials
Kotara, New South Wales, Australia
Canopy Clinical Sutherland
Miranda, New South Wales, Australia
Innovate Clinical Research
Waitara, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Canopy Clinical Wollongong
Wollongong, New South Wales, Australia
Paratus Clinical Research Brisbane
Herston, Queensland, Australia
Mackay Hospital and Health Service
Mackay, Queensland, Australia
Gold Coast University Hospital
Southport, Queensland, Australia
South Australian Health and Medical Research Institute
Adelaide, South Australia, Australia
Lyell McEwin Hospital
Elizabeth Vale, South Australia, Australia
Grampians Health
Ballarat, Victoria, Australia
NeuroCentrix
Carlton, Victoria, Australia
Peninsula Therapeutic and Research Group
Frankston, Victoria, Australia
Multidisciplinary Alfred Psychiatry Research Clinic
Melbourne, Victoria, Australia
Ramsay Clinic Albert Road
Melbourne, Victoria, Australia
Paratus Clinical Research Melbourne
Northcote, Victoria, Australia
Clinitrials
Perth, Western Australia, Australia
Countries
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Central Contacts
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Facility Contacts
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Haleh Shahidipour
Role: primary
A/Prof Bernadette Fitzgibbon
Role: backup
Other Identifiers
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HB-PD-002
Identifier Type: -
Identifier Source: org_study_id
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