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This is a pilot exploratory study to evaluate the safety and efficacy of TC-5214 in subjects with palmar hyperhidrosis.
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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 once daily (in the morning). |
|
| 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 once daily (in the morning). |
|
| Placebo | Placebo Comparator | Oral tablet containing no active drug. Subjects will be instructed to take two tablets by mouth once daily (in the morning). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmecamylamine HCl | Drug | Investigational drug |
|
| 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) |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects with Adverse Events (AEs) | From Baseline (Day 1) to End of Study (Day 22) |
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 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:
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 02 | San Diego | California | 92123 | United States | ||
| Site 03 |
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Subjects will be randomized (1:1:1) to one of three Treatment Arms
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The study drug will be provided as oral tablets with active and placebo indistinguishable in product and packing characteristics.
| Placebo | Other | Oral tablet containing no active drug. |
|
| Day 14 (End of Treatment) |
| St Louis |
| Missouri |
| 63122 |
| United States |
| Site 01 | Norfolk | Virginia | 23502 | United States |