Safety and Efficacy of HB-1 for Panic Disorder: A Multicenter, Randomized, Double Blind, Placebo-Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 8
- 主要终点
- Incidence of Treatment-Emergent Adverse Events
研究概览
简要总结
The purpose of this study is to determine the safety and efficacy of potential new treatment called "HB-1" versus placebo in male and female adult patients aged 18 to 60 years, inclusive, with panic disorder.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
An unblinded pharmacist will be utilized to assign bottles to each patient using an Interactive Voice Response System (IVRS) central randomization system. Study treatment or placebo will be dispensed to patients in blinded bottles.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •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).
- •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 estimated glomerular filtration rate (eGFR) <
- •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.
研究组 & 干预措施
Active Treatment (HB-01)
Approximately 40 patients will receive HB-01 active study drug.
干预措施: HB-01 (Drug)
Placebo Treatment
Approximately 40 patients will receive a matched placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events
时间窗: Up to 12 weeks
Safety was evaluated through Adverse Event monitoring, review of clinically significant changes in routine laboratory tests, ECGs, and orthostatic vital signs. The safety results were presented as: number of subjects reporting an adverse event as percentage of study population that met the eligibility criteria.
Change in Clinical Global Impression-Severity Scale (CGI-S)
时间窗: Up to 12 weeks
CGI-S is a 7 point scale where 1 indicates "normal, not at all ill" and 7 indicates "amongst the most extremely ill patients".
Change in Panic Disorder Symptom Severity Scale (PDSS)
时间窗: Up to 12 weeks
Percentage of patients who achieved panic free status after 12 weeks"
次要结局
- Number of Panic Attacks(Up to 12 weeks)