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

Palmar Hyperhidrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03404570
• Other study ID #: 217-9951-201
• Status: Completed
• Phase: Phase 2
• Start date: December 21, 2017
• Est. completion date: January 18, 2019

Study information

• Verified date: November 2019
• Source: Atacama Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a pilot exploratory study to evaluate the safety and efficacy of TC-5214 in subjects with palmar hyperhidrosis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 18, 2019
• Est. primary completion date: January 18, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 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 smoker 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 treatments for hyperhidrosis within four weeks 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.

• Subject has a history of sensitivity to any of the ingredients in the study drugs.

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
United States	Site 03	Saint Louis	Missouri
United States	Site 02	San Diego	California

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)		From Baseline (Day 1) to End of Study (Day 22)
Primary	HDSS Success	Proportion of subjects with at least a 1, 2, or 3 point reduction in Hyperhidrosis Disease Severity Scale (HDSS) score from Baseline	Day 14 (End of Treatment)
Secondary	Reduction in Sweat Production	Proportion of subjects with a =50% reduction in gravimetrically measured sweat production	Day 14 (End of Treatment)
Secondary	Absolute change of Sweat Production	Absolute change from Baseline in gravimetrically measured sweat production.	Day 14 (End of Treatment)