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

Primary Purpose

Palmar Hyperhidrosis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Dexmecamylamine HCl
Placebo
Sponsored by
Atacama Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Palmar Hyperhidrosis focused on measuring Sweaty Hands

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Site 02
  • Site 03
  • Site 01

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

High Dose (4 mg)

Low Dose (2 mg)

Placebo

Arm Description

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).

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).

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

Outcomes

Primary Outcome Measures

HDSS Success
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

Reduction in Sweat Production
Proportion of subjects with a ≥50% reduction in gravimetrically measured sweat production
Absolute change of Sweat Production
Absolute change from Baseline in gravimetrically measured sweat production.

Full Information

First Posted
December 22, 2017
Last Updated
November 18, 2019
Sponsor
Atacama Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT03404570
Brief Title
Exploratory Study to Assess the Efficacy and Safety of TC-5214 in the Treatment of Subjects With Palmar Hyperhidrosis
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
December 21, 2017 (Actual)
Primary Completion Date
January 18, 2019 (Actual)
Study Completion Date
January 18, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Atacama Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Palmar Hyperhidrosis
Keywords
Sweaty Hands

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Subjects will be randomized (1:1:1) to one of three Treatment Arms
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The study drug will be provided as oral tablets with active and placebo indistinguishable in product and packing characteristics.
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High Dose (4 mg)
Arm Type
Experimental
Arm Description
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).
Arm Title
Low Dose (2 mg)
Arm Type
Experimental
Arm Description
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).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Oral tablet containing no active drug. Subjects will be instructed to take two tablets by mouth once daily (in the morning).
Intervention Type
Drug
Intervention Name(s)
Dexmecamylamine HCl
Other Intervention Name(s)
TC-5214
Intervention Description
Investigational drug
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Oral tablet containing no active drug.
Primary Outcome Measure Information:
Title
HDSS Success
Description
Proportion of subjects with at least a 1, 2, or 3 point reduction in Hyperhidrosis Disease Severity Scale (HDSS) score from Baseline
Time Frame
Day 14 (End of Treatment)
Secondary Outcome Measure Information:
Title
Reduction in Sweat Production
Description
Proportion of subjects with a ≥50% reduction in gravimetrically measured sweat production
Time Frame
Day 14 (End of Treatment)
Title
Absolute change of Sweat Production
Description
Absolute change from Baseline in gravimetrically measured sweat production.
Time Frame
Day 14 (End of Treatment)
Other Pre-specified Outcome Measures:
Title
Number of Subjects with Adverse Events (AEs)
Time Frame
From Baseline (Day 1) to End of Study (Day 22)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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: Iontophoresis to the palms within four weeks prior to baseline visit; Botulinum toxin to the palms within one year prior to baseline visit; Prior surgical procedures to the palms (e.g., sympathectomy, debulking of sweat glands); Prior medical device treatment to the palms (approved or investigational); 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.
Facility Information:
Facility Name
Site 02
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Site 03
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63122
Country
United States
Facility Name
Site 01
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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