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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06483789




Registration number
NCT06483789
Ethics application status
Date submitted
26/06/2024
Date registered
3/07/2024

Titles & IDs
Public title
Efficacy and Safety of HB-1 for Panic Disorder
Scientific title
Efficacy and Safety of HB-1 for Panic Disorder: a Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial
Secondary ID [1] 0 0
HB-PD-002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Panic Disorder 0 0
Mental Illness 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - HB-1
Treatment: Drugs - Telmisartan Only Product in Oral Dose Form
Treatment: Drugs - Verapamil Only Product in Oral Dose Form
Treatment: Drugs - Placebo

Experimental: HB-1 - HB-1 fixed dose, once daily.

Experimental: Telmisartan - Telmisartan fixed dose, once daily.

Experimental: Verapamil - Verapamil fixed dose, once daily.

Placebo comparator: Placebo - Placebo treatment, once daily


Treatment: Drugs: HB-1
HB-1 will be supplied as a dual active pharmaceutical ingredient tablet.

Treatment: Drugs: Telmisartan Only Product in Oral Dose Form
Telmisartan will be supplied as a single active pharmaceutical ingredient tablet.

Treatment: Drugs: Verapamil Only Product in Oral Dose Form
Verapamil will be supplied as a single active pharmaceutical ingredient tablet.

Treatment: Drugs: Placebo
Matched Placebo will be supplied as a tablet.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Unexpected Panic Attacks
Timepoint [1] 0 0
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
Primary outcome [2] 0 0
Incidence of Treatment-Emergent Adverse Events
Timepoint [2] 0 0
Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12 and Week 13.
Secondary outcome [1] 0 0
Change in Clinical Global Impression-Severity Scale (CGI-S)
Timepoint [1] 0 0
Baseline, Week 4, Week 8 and Week 12
Secondary outcome [2] 0 0
Change in Panic Disorder Symptom Severity Scale (PDSS)
Timepoint [2] 0 0
Screening, Week 4, Week 8 and Week 12

Eligibility
Key inclusion criteria
1. Male or female aged 18 to 65 years old, inclusive, at the time of informed consent.
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.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. 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.
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).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/10/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/02/2026
Actual
Sample size
Target
240
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
East Sydney Doctors - Darlinghurst
Recruitment hospital [2] 0 0
Momentum Clinical Research Darlinghurst - Darlinghurst
Recruitment hospital [3] 0 0
Novatrials - Kotara
Recruitment hospital [4] 0 0
Sutherland Shire Clinical Research - Miranda
Recruitment hospital [5] 0 0
Innovate Clinical Research - Waitara
Recruitment hospital [6] 0 0
Westmead Hospital - Westmead
Recruitment hospital [7] 0 0
Wollongong Clinical Research - Wollongong
Recruitment hospital [8] 0 0
Gold Coast University Hospital - Southport
Recruitment hospital [9] 0 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment hospital [10] 0 0
NeuroCentrix - Carlton
Recruitment hospital [11] 0 0
Peninsula Therapeutic and Research Group - Frankston
Recruitment hospital [12] 0 0
Multidisciplinary Alfred Psychiatry Research Clinic - Melbourne
Recruitment hospital [13] 0 0
Ramsay Clinic Albert Road - Melbourne
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2289 - Kotara
Recruitment postcode(s) [3] 0 0
2228 - Miranda
Recruitment postcode(s) [4] 0 0
2077 - Waitara
Recruitment postcode(s) [5] 0 0
2145 - Westmead
Recruitment postcode(s) [6] 0 0
2500 - Wollongong
Recruitment postcode(s) [7] 0 0
4215 - Southport
Recruitment postcode(s) [8] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [9] 0 0
3053 - Carlton
Recruitment postcode(s) [10] 0 0
3199 - Frankston
Recruitment postcode(s) [11] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Honeybrains Biotech LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jennifer Grunfeld
Address 0 0
Peninsula Therapeutic and Research Group
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Karen Smith
Address 0 0
Country 0 0
Phone 0 0
+1-650-722-9813
Fax 0 0
Email 0 0
karen.smith@hbbio.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06483789