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

Hyperhidrosis Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04263623
• Other study ID #: 217-9951-202
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: January 31, 2020
• Est. completion date: September 2021

Study information

• Verified date: July 2021
• Source: Atacama Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 75
• Est. completion date: September 2021
• Est. primary completion date: December 3, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hyperhidrosis
• Palmar Hyperhidrosis

Intervention

Drug:
• Dexmecamylamine HCl
Investigational drug

Other:
• Placebo
Oral tablet containing no active drug.

Locations

Country	Name	City	State
United States	Site 01	Norfolk	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Atacama Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Subjects with Adverse Events (AEs)		Baseline (Day 1) to End of Study (Day 43)
Primary	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	Absolute change in PHIS	Absolute change from the mean baseline value in PHIS	Week 6 (End of Study)
Secondary	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)
Secondary	Absolute change of Sweat Production	Absolute change from mean baseline value in gravimetrically measured sweat production.	Week 6 (End of Study)