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

• Status: Active, not recruiting
• Trial end date: 2021-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Atacama Therapeutics

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.