Safety and Efficacy of HB-1 for Panic Disorder

Panic Disorder Clinical Trial

Official title:

Safety and Efficacy of HB-1 for Panic Disorder: A Multicenter, Randomized, Double Blind, Placebo-Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05071430
• Other study ID #: HB-001
• Status: Completed
• Phase: Phase 2
• Start date: February 3, 2022
• Est. completion date: December 12, 2022

Study information

• Verified date: December 2022
• Source: Honeybrains Biotech LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: December 12, 2022
• Est. primary completion date: December 12, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

• Inclusion Criteria

1. Male or female aged 18 to 60 years old, inclusive, at the time of informed consent.

2. Meets DSM-5 Criteria for Panic Disorder.

3. Documented moderate to severe levels of symptoms at baseline (Panic Disorder Severity Scale of 13 or above)

4. Medically stable on current medication regimen for at least 3 months (including PRN medications), as determined by Investigator.

5. 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).

6. 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.

7. Fluent in English.

8. Willing to take HB-1 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 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.

11. 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:

1. 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).

2. Any clinically significant electrocardiogram (ECG) abnormalities at screening.

3. 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.

4. Inadequate renal function defined as serum creatinine >1.5 × the ULN range of each institution and/or eGFR <60.

5. Any clinically significant abnormalities in clinical laboratory assessments as assessed by the Investigator.

6. 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.

7. Unable to complete neuropsychological testing.

8. Diagnosis of Bipolar I, Bipolar II disorder or Schizophrenia.

9. History of suicidal behaviors including ideation.

10. Current treatment with doses of benzodiazepines that are outside the FDA-approved prescriber's information.

11. Already on treatment with either telmisartan or verapamil or both.

12. Documented prior drug allergy to either telmisartan or verapamil.

13. Documented contraindication to taking telmisartan or verapamil: (eg, Duchenne's muscular dystrophy, myasthenia gravis).

14. Documented moderate to severe substance abuse within the last 6 months (recreational cannabis use is allowed).

15. Pregnant or breastfeeding.

Related Conditions & MeSH terms

• Panic Disorder

Intervention

Drug:
• HB-01
HB-1 will be supplied as a dual active pharmaceutical ingredient tablet.
• Placebo
HB-1 matched placebo

Locations

Country	Name	City	State
United States	Hassman Research Institute	Berlin	New Jersey
United States	SPRI Clinical Trials	Brooklyn	New York
United States	Uptown Research Institute	Chicago	Illinois
United States	Collaborative Neuroscience Research	Garden Grove	California
United States	Institute of Living	Hartford	Connecticut
United States	CNS Healthcare	Jacksonville	Florida
United States	CNS Healthcare	Memphis	Tennessee
United States	CNS Healthcare	Orlando	Florida
United States	Lumos Psychiatric Services	San Jose	California
United States	Richmond Behavioral Associates	Staten Island	New York

Sponsors (2)

Lead Sponsor	Collaborator
Honeybrains Biotech LLC	Cognitive Research Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Treatment-Emergent Adverse Events	Safety will be evaluated through Adverse Event monitoring, review of clinically significant changes in routine laboratory tests, ECGs, and orthostatic vital signs.	Baseline, Week 2, Week 4, Week 8 and Week 12
Primary	Number of Panic Attacks	Efficacy will be evaluated through a comparison of the number of panic attacks from Baseline as compared to protocol-specified timepoints per protocol.	Baseline, Week 2, Week 4, Week 8 and Week 12
Primary	Change in Panic Disorder Symptom Severity Scale (PDSS)	Efficacy will be evaluated through an evaluation in PDSS scores from Baseline as compared to protocol-specified timepoints per protocol.	Baseline, Week 2, Week 4, Week 8 and Week 12
Primary	Change in Clinical Global Impression-Severity Scale (CGI-I)	Efficacy will be evaluated through an evaluation in CGI-I scores from Baseline as compared to protocol-specified timepoints per protocol.	Baseline, Week 2, Week 4, Week 8 and Week 12