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

Phase 2

Completed

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

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Low Dose (2 mg)	Dexmecamylamine HCl	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	Oral tablet containing no active drug. Subjects will be instructed to take two tablets by mouth once daily (in the morning).
High Dose (4 mg)	Dexmecamylamine HCl	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).

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Locations (3): Site 03
🇺🇸
Saint Louis, Missouri, United States
Site 01
🇺🇸
Norfolk, Virginia, United States
Site 02
🇺🇸
San Diego, California, United States