A Double-Blind, Randomized, Placebo-Controlled Study to Assess the Efficacy and Safety of AT-5214 in the Treatment of Subjects With Moderate to Severe Palmar Hyperhidrosis
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- PHIS Reduction
研究概览
简要总结
This is a multicenter, randomized, double-blind, placebo-controlled, parallel group comparison study of AT-5214 in subjects with moderate to severe primary palmar hyperhidrosis (sweaty palms). This study will compare two different oral (tablet) doses of AT-5214 (study drug) versus a matched placebo. Approximately 120 subjects will be enrolled at approximately 10 study sites.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has a clinical diagnosis of primary hyperhidrosis of the palms
- •Subject is currently drug-naïve for hyperhidrosis medications
- •Females must be post-menopausal, surgically sterile, or use an effective method of birth control
排除标准
- •Subject is pregnant, lactating, is planning to become pregnant during the study, or is less than one year postpartum.
- •Subject is a user of nicotine products within one year prior to Visit 1/Screening.
- •Subject has known history of secondary hyperhidrosis.
- •Subject has existence of neurological, psychiatric, endocrine, or other disease that can cause secondary hyperhidrosis or affect sweating.
- •Subject has known history of Sjögren's syndrome or Sicca syndrome.
- •Subject has used any of the following hyperhidrosis medications or therapies within the specified timeframe:
- •Iontophoresis to the palms within four weeks prior to baseline visit;
- •Botulinum toxin to the palms within one year prior to baseline visit;
- •Prior surgical procedures to the palms (e.g., sympathectomy, debulking of sweat glands);
- •Prior medical device treatment to the palms (approved or investigational);
- •Any prescription treatments for hyperhidrosis within four weeks prior to baseline visit.
- •Any topical antiperspirant treatment to the palms within 7 days prior to baseline visit.
- •Subject is currently enrolled in an investigational drug or device study.
- •Subject has previously participated in a clinical study of dexmecamylamine or TC-
- •Subject has used an investigational drug or investigational device treatment within 30 days prior to baseline.
研究组 & 干预措施
High Dose (4 mg)
Oral tablet containing 2 mg of active drug, dexmecamylamine HCl. Subjects will be instructed to take two tablets by mouth twice daily (in the morning and evening).
干预措施: Dexmecamylamine HCl (Drug)
Low Dose (2 mg)
Oral tablet containing 1 mg of active drug, dexmecamylamine HCl. Subjects will be instructed to take two tablets by mouth twice daily (in the morning and evening).
干预措施: Dexmecamylamine HCl (Drug)
Placebo
Oral tablet containing no active drug. Subjects will be instructed to take two tablets by mouth twice daily (in the morning and evening).
干预措施: Placebo (Other)
结局指标
主要结局
PHIS Reduction
时间窗: Week 6 (End of Study)
Proportion of subjects with at least a 2-point reduction in the Palmar Hyperhidrosis Impact Scale (PHIS) from their mean baseline value (rated on an 11-point scale, 0-10).
次要结局
- Absolute change in PHIS(Week 6 (End of Study))
- Change in Sweat Production(Week 6 (End of Study))
- Absolute change of Sweat Production(Week 6 (End of Study))