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Completed

NCT Number: NCT03404570

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Site 02, San Diego, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexmecamylamine HCl

Drug

Investigational drug

Other names: TC-5214

Placebo

Other

Oral tablet containing no active drug.

Primary outcomes

  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 outcomes

  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 outcomes

  1. Number of Subjects with Adverse Events (AEs)

    Time frame: From Baseline (Day 1) to End of Study (Day 22)

Sponsors and collaborators

Lead sponsor

Atacama Therapeutics

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jan 19, 2018
Registry last updated
Nov 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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