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

• ClinicalTrials.gov Identifier: NCT03404570
• Recruitment Status: Completed
• First Posted: January 19, 2018
• Last Update Posted: November 21, 2019
• Sponsor: Atacama Therapeutics
• Information provided by (Responsible Party): Atacama Therapeutics

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Palmar Hyperhidrosis	Drug: Dexmecamylamine HCl; Other: Placebo	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Subjects will be randomized (1:1:1) to one of three Treatment Arms
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: The study drug will be provided as oral tablets with active and placebo indistinguishable in product and packing characteristics.
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: December 21, 2017
• Actual Primary Completion Date: January 18, 2019
• Actual Study Completion Date: January 18, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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).	Drug: Dexmecamylamine HCl; Investigational drug; Other Name: TC-5214
Experimental: 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).	Drug: Dexmecamylamine HCl; Investigational drug; Other Name: TC-5214
Placebo Comparator: Placebo; Oral tablet containing no active drug. Subjects will be instructed to take two tablets by mouth once daily (in the morning).	Other: Placebo; Oral tablet containing no active drug.

Outcome Measures

Primary Outcome Measures :

1. HDSS Success [ Time Frame: Day 14 (End of Treatment) ]
   Proportion of subjects with at least a 1, 2, or 3 point reduction in Hyperhidrosis Disease Severity Scale (HDSS) score from Baseline

Secondary Outcome Measures :

1. Reduction in Sweat Production [ Time Frame: Day 14 (End of Treatment) ]
   Proportion of subjects with a ≥50% reduction in gravimetrically measured sweat production
2. Absolute change of Sweat Production [ Time Frame: Day 14 (End of Treatment) ]
   Absolute change from Baseline in gravimetrically measured sweat production.

Other Outcome Measures:

1. Number of Subjects with Adverse Events (AEs) [ Time Frame: From Baseline (Day 1) to End of Study (Day 22) ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, California

Site 02

San Diego, California, United States, 92123

United States, Missouri

Site 03

Saint Louis, Missouri, United States, 63122

United States, Virginia

Site 01

Norfolk, Virginia, United States, 23502

Sponsors and Collaborators

Atacama Therapeutics

More Information

• Responsible Party: Atacama Therapeutics
• ClinicalTrials.gov Identifier: NCT03404570
• Other Study ID Numbers: 217-9951-201
• First Posted: January 19, 2018
• Last Update Posted: November 21, 2019
• Last Verified: November 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Atacama Therapeutics:

Sweaty Hands

Additional relevant MeSH terms:

Hyperhidrosis; Sweat Gland Diseases; Skin Diseases