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

Phase 2

Completed

• Conditions: Palmar Hyperhidrosis
• Interventions: Drug: Dexmecamylamine HCl; Other: Placebo

• Registration Number: NCT03404570
• Lead Sponsor: Atacama Therapeutics

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-12-21
• Study First Submitted: 2017-12-22
• Study First Submitted QC: 2018-01-12
• Study First Posted: 2018-01-19
• Primary Completion: 2019-01-18
• Study Completion: 2019-01-18
• Status Verified: 2019-11
• Disposition First Submitted: 2019-11-18
• Disposition First Submitted QC: 2019-11-18
• Last Update Submitted: 2019-11-18
• Disposition First Posted: 2019-11-21
• Last Update Posted: 2019-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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
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.

Trial Locations

Locations (3)

Site 02; 🇺🇸 San Diego, California, United States

Site 03; 🇺🇸 Saint Louis, Missouri, United States

Site 01; 🇺🇸 Norfolk, Virginia, United States