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

NCT ID: NCT03404570

Last Updated: 2019-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-21
• Study Completion Date: 2019-01-18

Brief Summary

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

Conditions

Palmar Hyperhidrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

High Dose (4 mg)

Oral tablet containing 2 mg of active drug, dexmecamylamine HCl. Subjects will be instructed to take two tablets by mouth once daily (in the morning).

Group Type: EXPERIMENTAL

Dexmecamylamine HCl

Intervention Type: DRUG

Investigational drug

Low Dose (2 mg)

Oral tablet containing 1 mg of active drug, dexmecamylamine HCl. Subjects will be instructed to take two tablets by mouth once daily (in the morning).

Group Type: EXPERIMENTAL

Dexmecamylamine HCl

Intervention Type: DRUG

Investigational drug

Placebo

Oral tablet containing no active drug. Subjects will be instructed to take two tablets by mouth once daily (in the morning).

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Oral tablet containing no active drug.

Interventions

Dexmecamylamine HCl

Investigational drug

Intervention Type: DRUG

Placebo

Oral tablet containing no active drug.

Intervention Type: OTHER

Other Intervention Names

TC-5214

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 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Atacama Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Site 02

San Diego, California, United States

Site 03

St Louis, Missouri, United States

Site 01

Norfolk, Virginia, United States

Countries

United States

Other Identifiers

217-9951-201

Identifier Type: -

Identifier Source: org_study_id