Safety and Efficacy of HB-1 for Panic Disorder

  • STATUS
    Recruiting
  • End date
    Jan 31, 2023
  • participants needed
    80
  • sponsor
    Honeybrains Biotech LLC
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Updated on 15 March 2022
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lithium

Summary

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 60 years, inclusive, with Panic Disorder.

Description

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 80 adult patients who meet the diagnosis of panic disorder.

The patients will be treated for 12 weeks including a 1 week safety follow up visit following the last dose of study drug.

Details
Condition Panic Disorder
Treatment Placebo, HB-01
Clinical Study IdentifierNCT05071430
SponsorHoneybrains Biotech LLC
Last Modified on15 March 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Male or female aged 18 to 60 years old, inclusive, at the time of informed consent
Meets DSM-5 Criteria for Panic Disorder
Documented moderate to severe levels of symptoms at baseline (Panic Disorder Severity Scale of 13 or above)
Medically stable on current medication regimen for at least 3 months (including PRN medications), as determined by Investigator
Willing to remain on current doses of other psychiatric medications throughout the length of the trial (unless a dose reduction is warranted due to improvement in symptoms)
Willing and able to safely stop any of the following medications prior to study trial: Inhibitors or inducers of CYP3A4 (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
Fluent in English
Willing to take HB-1 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 patients must be surgically sterile (or have a monogamous partner who is surgically sterile) or be least 2 years postmenopausal or commits 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 patients must be sterile (biologically or surgically) or commit to the use of a reliable method of birth control (condoms with 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 patients 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

Severe uncontrolled cardiac disease within 6 months of Screening, including but
not limited to uncontrolled hypertension, hypotension (defined as below
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 ULN range of each institution and/or 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
Diagnosis of Bipolar I, Bipolar II disorder or Schizophrenia
History of suicidal behaviors including ideation
Current treatment with doses of benzodiazepines that are outside the FDA-approved prescriber's information
Already on treatment with either telmisartan or verapamil or both
Documented prior drug allergy to either telmisartan or verapamil
Documented contraindication to taking telmisartan or verapamil: (eg, Duchenne's muscular dystrophy, myasthenia gravis)
Documented moderate to severe substance abuse within the last 6 months (recreational cannabis use is allowed)
Pregnant or breastfeeding
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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