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

NCT04263623 | Unknown Phase 2 FDA Drug

• 1 other identifier: 217-9951-202
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperhidrosis; Palmar Hyperhidrosis

Keywords

sweaty palms

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Absolute change in PHIS

  Week 6 (End of Study)

• Change in Sweat Production

  Week 6 (End of Study)

• Absolute change of Sweat Production

  Week 6 (End of Study)

Other Outcomes (1)

• Number of Subjects with Adverse Events (AEs)

  Baseline (Day 1) to End of Study (Day 43)

Study Arms (3)

High Dose (4 mg)

EXPERIMENTAL

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

Low Dose (2 mg)

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Dexmecamylamine HCl DRUG

Investigational drug

Also known as: AT-5214

High Dose (4 mg); Low Dose (2 mg)

Placebo OTHER

Oral tablet containing no active drug.

Placebo

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:
• Iontophoresis to the palms within four weeks prior to baseline visit;
• Botulinum toxin to the palms within one year prior to baseline visit;
• Prior surgical procedures to the palms (e.g., sympathectomy, debulking of sweat glands);
• Prior medical device treatment to the palms (approved or investigational);
• Any prescription treatments for hyperhidrosis within four weeks prior to baseline visit.
• 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.

Sponsors & Collaborators

• Atacama Therapeutics: lead

Study Sites (1)

Site 01

Norfolk, Virginia, 23502, United States

Location

MeSH Terms

Conditions

Hyperhidrosis

Condition Hierarchy (Ancestors)

Sweat Gland Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2020
• First Posted: February 11, 2020
• Study Start: January 31, 2020
• Primary Completion: December 3, 2020
• Study Completion: September 1, 2021
• Last Updated: July 22, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)