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Efficacité et innocuité du HB-1 pour le trouble panique : un essai multicentrique, randomisé, en double aveugle et contrôlé par placebo

21 septembre 2026 mis à jour par: HB BioTech, LLC

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.

Aperçu de l'étude

Statut

Résilié

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

170

Phase

  • Phase 2

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Australie
    • Australian Capital Territory
      • Canberra, Australian Capital Territory, Australie, 2617
        • Paratus Clinical Research Canberra
    • New South Wales
      • Blacktown, New South Wales, Australie, 2148
        • Paratus Clinical Research Western Sydney
      • Charlestown, New South Wales, Australie, 2290
        • Novatrials
      • Darlinghurst, New South Wales, Australie, 2010
        • East Sydney Doctors
      • Darlinghurst, New South Wales, Australie, 2010
        • Momentum Clinical Research Darlinghurst
      • Miranda, New South Wales, Australie, 2228
        • Canopy Clinical Sutherland
      • Waitara, New South Wales, Australie, 2077
        • Innovate Clinical Research
      • Westmead, New South Wales, Australie, 2145
        • Westmead Hospital
      • Wollongong, New South Wales, Australie, 2500
        • Canopy Clinical Wollongong
    • Queensland
      • Herston, Queensland, Australie, 4006
        • Paratus Clinical Research Brisbane
      • Mackay, Queensland, Australie, 4740
        • Mackay Hospital and Health Service
    • South Australia
      • Adelaide, South Australia, Australie, 5000
        • South Australian Health and Medical Research Institute
    • Victoria
      • Carlton, Victoria, Australie, 3053
        • NeuroCentrix
      • Frankston, Victoria, Australie, 3199
        • Peninsula Therapeutic and Research Group
      • Melbourne, Victoria, Australie, 3004
        • Ramsay Clinic Albert Road
      • Melbourne, Victoria, Australie, 3004
        • Multidisciplinary Alfred Psychiatry Research Clinic
      • Northcote, Victoria, Australie, 3070
        • Paratus Clinical Research Melbourne
      • Torquay, Victoria, Australie, 3228
        • Clinical Trials Institute
    • Western Australia
      • West Perth, Western Australia, Australie, 6005
        • Clinitrials

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 65 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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.

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).

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Tripler

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: HB-1

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

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

Autres noms:
  • Telmisartan/Vérapamil comprimé à dose fixe
Expérimental: Telmisartan

Telmisartan fixed dose, once daily.
Médicament: Telmisartan Only Product in Oral Dose Form

Telmisartan will be supplied as a single active pharmaceutical ingredient tablet.

Autres noms:
  • Telmisartan
Expérimental: Verapamil

Verapamil fixed dose, once daily.
Médicament: Verapamil Only Product in Oral Dose Form

Verapamil will be supplied as a single active pharmaceutical ingredient tablet.

Autres noms:
  • Vérapamil
Comparateur placebo: Placebo

Placebo treatment, once daily
Médicament: Placebo

Matched Placebo will be supplied as a tablet.

Autres noms:
  • Placebo apparié

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Number of Unexpected Panic Attacks
Délai: Screening, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, and Week 12

Efficacy will be evaluated through a comparison of the number of unexpected panic attack days (over the last 10 weeks in a 12-week treatment period) from Screening as compared to protocol-specified timepoints per protocol.
Screening, 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
Délai: Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12 and Week 13.

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.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change in Clinical Global Impression-Severity Scale (CGI-S)
Délai: Baseline, Week 4, Week 8 and Week 12

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)
Délai: Screening, Week 4, Week 8 and Week 12

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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

HB BioTech, LLC

Les enquêteurs

  • Chercheur principal: Prof. Malcolm Hopwood, Ramsay Clinic Albert Road

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

29 octobre 2024

Achèvement primaire (Réel)

9 septembre 2026

Achèvement de l'étude (Réel)

9 septembre 2026

Dates d'inscription aux études

Première soumission

26 juin 2024

Première soumission répondant aux critères de contrôle qualité

26 juin 2024

Première publication (Réel)

3 juillet 2024

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

24 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

21 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • HB-PD-002

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Oui

Étudie un produit d'appareil réglementé par la FDA américaine

Non

produit fabriqué et exporté des États-Unis.

Oui

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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