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

• Dexmecamylamine HCl (Drug), also known as TC-5214: Investigational drug
• Placebo (Other): Oral tablet containing no active drug.

Primary outcomes

• HDSS Success [Day 14 (End of Treatment)]: Proportion of subjects with at least a 1, 2, or 3 point reduction in Hyperhidrosis Disease Severity Scale (HDSS) score from Baseline

Secondary outcomes

• Reduction in Sweat Production [Day 14 (End of Treatment)]: Proportion of subjects with a ≥50% reduction in gravimetrically measured sweat production
• Absolute change of Sweat Production [Day 14 (End of Treatment)]: Absolute change from Baseline in gravimetrically measured sweat production.

Other outcomes

• Number of Subjects with Adverse Events (AEs) [From Baseline (Day 1) to End of Study (Day 22)]

Sex: All, ages: 18 Years to any

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:

  1. Iontophoresis to the palms within four weeks prior to baseline visit;
  2. Botulinum toxin to the palms within one year prior to baseline visit;
  3. Prior surgical procedures to the palms (e.g., sympathectomy, debulking of sweat glands);
  4. Prior medical device treatment to the palms (approved or investigational);
  5. 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.