Clinical Study to Assess the Efficacy and Safety of AT-5214 in the Treatment of Subjects With Palmar Hyperhidrosis

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Hyperhidrosis, Palmar Hyperhidrosis

Intervention / Treatment
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* Drug: Dexmecamylamine HCl
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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); 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-5214. Subject has used an investigational drug or investigational device treatment within 30 days prior to baseline.

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High Dose (4 mg)<br>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). | Drug: Dexmecamylamine HCl<br>* Investigational drug<br>* Other names: AT-5214;|
| Experimental: Low Dose (2 mg)<br>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). | Drug: Dexmecamylamine HCl<br>* Investigational drug<br>* Other names: AT-5214;|
| Placebo Comparator: Placebo<br>Oral tablet containing no active drug. Subjects will be instructed to take two tablets by mouth twice daily (in the morning and evening). | Other: Placebo<br>* Oral tablet containing no active drug.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PHIS Reduction | 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). | Week 6 (End of Study) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute change in PHIS | Absolute change from the mean baseline value in PHIS | Week 6 (End of Study) | 
| Change in Sweat Production | Proportion of subjects with a ≥50% reduction from the mean baseline value in gravimetrically measured sweat production. | Week 6 (End of Study) | 
| Absolute change of Sweat Production | Absolute change from mean baseline value in gravimetrically measured sweat production. | Week 6 (End of Study) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sweaty palms