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
Overview
- Phase
- Phase 2
- Intervention
- Dexmecamylamine HCl
- Conditions
- Hyperhidrosis
- Sponsor
- Atacama Therapeutics
- Enrollment
- 75
- Locations
- 1
- Primary Endpoint
- PHIS Reduction
- Last Updated
- 4 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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);
Arms & Interventions
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).
Intervention: Dexmecamylamine HCl
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).
Intervention: Dexmecamylamine HCl
Placebo
Oral tablet containing no active drug. Subjects will be instructed to take two tablets by mouth twice daily (in the morning and evening).
Intervention: Placebo
Outcomes
Primary Outcomes
PHIS Reduction
Time Frame: 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).
Secondary Outcomes
- 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))