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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Dose (4 mg) | Experimental | 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). |
|
| Low Dose (2 mg) | Experimental | 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). |
|
| Placebo | Placebo Comparator | Oral tablet containing no active drug. Subjects will be instructed to take two tablets by mouth twice daily (in the morning and evening). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmecamylamine HCl | Drug | Investigational drug |
|
| 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) |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects with Adverse Events (AEs) | Baseline (Day 1) to End of Study (Day 43) |
Inclusion Criteria:
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:
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 01 | Norfolk | Virginia | 23502 | United States |
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| ID | Term |
|---|---|
| D006945 | Hyperhidrosis |
| ID | Term |
|---|---|
| D013543 | Sweat Gland Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Placebo | Other | Oral tablet containing no active drug. |
|
| 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) |