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

A Double-Blind, Randomized, Placebo-Controlled Study to Assess the Efficacy and Safety of AT-5214 in the Treatment of Subjects With Moderate to Severe Palmar Hyperhidrosis

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Hyperhidrosis; Palmar Hyperhidrosis
• Intervention / Treatment: Drug: Dexmecamylamine HCl; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Site 01

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 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:

  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 prescription treatments for hyperhidrosis within four weeks prior to baseline visit.
  6. Any topical antiperspirant treatment to the palms within 7 days 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High Dose (4 mg); 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).	Drug: Dexmecamylamine HCl; Investigational drug; Other Names: AT-5214
Experimental: Low Dose (2 mg); 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).	Drug: Dexmecamylamine HCl; Investigational drug; Other Names: AT-5214
Placebo Comparator: Placebo; Oral tablet containing no active drug. Subjects will be instructed to take two tablets by mouth twice daily (in the morning and evening).	Other: Placebo; Oral tablet containing no active drug.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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.	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)

Other Outcome Measures

Outcome Measure	Time Frame
Number of Subjects with Adverse Events (AEs)	Baseline (Day 1) to End of Study (Day 43)

Collaborators and Investigators

• Sponsor: Atacama Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2020
• Primary Completion (Actual): December 3, 2020
• Study Completion (Anticipated): September 1, 2021

Study Registration Dates

• First Submitted: February 7, 2020
• First Submitted That Met QC Criteria: February 7, 2020
• First Posted (Actual): February 11, 2020

Study Record Updates

• Last Update Posted (Actual): July 22, 2021
• Last Update Submitted That Met QC Criteria: July 20, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: sweaty palms
• Additional Relevant MeSH Terms: Sweat Gland Diseases; Skin Diseases; Hyperhidrosis
• Other Study ID Numbers: 217-9951-202

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No