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

• ClinicalTrials.gov Identifier: NCT04263623
• Recruitment Status: Active, not recruiting
• First Posted: February 11, 2020
• Last Update Posted: July 22, 2021
• Sponsor: Atacama Therapeutics
• Information provided by (Responsible Party): Atacama Therapeutics

Tracking Information

• First Submitted Date: February 7, 2020
• First Posted Date: February 11, 2020
• Last Update Posted Date: July 22, 2021
• Actual Study Start Date: January 31, 2020
• Actual Primary Completion Date: December 3, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 10, 2020)

PHIS Reduction [ Time Frame: Week 6 (End of Study) ]

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).

Original Primary Outcome Measures (submitted: February 7, 2020)

PHIS Reduction [ Time Frame: Week 6 (End of Study) ]

Proportion of subjects with at least a 2-point reduction in the Palmar Hyperhidrosis Impact Scale (PHIS) from their mean baseline value.

Current Secondary Outcome Measures (submitted: February 10, 2020)

• Absolute change in PHIS [ Time Frame: Week 6 (End of Study) ]
  Absolute change from the mean baseline value in PHIS
• Change in Sweat Production [ Time Frame: Week 6 (End of Study) ]
  Proportion of subjects with a ≥50% reduction from the mean baseline value in gravimetrically measured sweat production.
• Absolute change of Sweat Production [ Time Frame: Week 6 (End of Study) ]
  Absolute change from mean baseline value in gravimetrically measured sweat production.

Original Secondary Outcome Measures (submitted: February 7, 2020)

• Absolute change in PHIS [ Time Frame: Week 6 (End of Study) ]
  Absolute change from the mean baseline value in PHIS
• Reduction in Sweat Production [ Time Frame: Week 6 (End of Study) ]
  Proportion of subjects with a ≥50% reduction from the mean baseline value in gravimetrically measured sweat production.
• Absolute change of Sweat Production [ Time Frame: Week 6 (End of Study) ]
  Absolute change from mean baseline value in gravimetrically measured sweat production.

• Current Other Pre-specified Outcome Measures (submitted: February 7, 2020): Number of Subjects with Adverse Events (AEs) [ Time Frame: Baseline (Day 1) to End of Study (Day 43) ]
• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: Clinical Study to Assess the Efficacy and Safety of AT-5214 in the Treatment of Subjects With Palmar Hyperhidrosis
• Official Title: 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
• Brief Summary: 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Hyperhidrosis
• Palmar Hyperhidrosis

Intervention

• Drug: Dexmecamylamine HCl
  Investigational drug
  Other Name: AT-5214
• Other: Placebo
  Oral tablet containing no active drug.

Study Arms

• 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).
  Intervention: Drug: Dexmecamylamine HCl
• 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).
  Intervention: Drug: Dexmecamylamine HCl
• 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).
  Intervention: Other: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: May 7, 2021): 75
• Original Estimated Enrollment (submitted: February 7, 2020): 120
• Estimated Study Completion Date: September 2021
• Actual Primary Completion Date: December 3, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 16 Years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04263623
• Other Study ID Numbers: 217-9951-202
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Atacama Therapeutics
• Original Responsible Party: Same as current
• Current Study Sponsor: Atacama Therapeutics
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Atacama Therapeutics
• Verification Date: July 2021