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

Study Overview
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Brief Summary
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This is a pilot exploratory study to evaluate the safety and efficacy of TC-5214 in subjects with palmar hyperhidrosis.

Official Title
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A Double-Blind, Randomized, Placebo-Controlled Exploratory Study to Assess the Efficacy and Safety of TC-5214 in the Treatment of Subjects With Moderate to Severe Palmar Hyperhidrosis

Conditions
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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 smoker 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 treatments for hyperhidrosis within four weeks 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. Subject has a history of sensitivity to any of the ingredients in the study drugs.

Ages Eligible for Study
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Minimum Age: 18 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
Interventional Model Description: Subjects will be randomized (1:1:1) to one of three Treatment Arms
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 once daily (in the morning). | Drug: Dexmecamylamine HCl<br>* Investigational drug<br>* Other names: TC-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 once daily (in the morning). | Drug: Dexmecamylamine HCl<br>* Investigational drug<br>* Other names: TC-5214;|
| Placebo Comparator: Placebo<br>Oral tablet containing no active drug. Subjects will be instructed to take two tablets by mouth once daily (in the morning). | 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 |
| --- | --- | --- |
| HDSS Success | Proportion of subjects with at least a 1, 2, or 3 point reduction in Hyperhidrosis Disease Severity Scale (HDSS) score from Baseline | Day 14 (End of Treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in Sweat Production | Proportion of subjects with a ≥50% reduction in gravimetrically measured sweat production | Day 14 (End of Treatment) | 
| Absolute change of Sweat Production | Absolute change from Baseline in gravimetrically measured sweat production. | Day 14 (End of Treatment) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sweaty Hands