Trial | NCT03404570  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    60
This is a pilot exploratory study to evaluate the safety and efficacy of TC-5214 in subjects with palmar hyperhidrosis.
Study Started
Dec 21
2017
Primary Completion
Jan 18
2019
Study Completion
Jan 18
2019
Last Update
Nov 21
2019

Drug Dexmecamylamine HCl

Investigational drug

  • Other names: TC-5214

Other Placebo

Oral tablet containing no active drug.

Low Dose (2 mg) Experimental

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).

High Dose (4 mg) Experimental

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).

Placebo Placebo Comparator

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

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.
No Results Posted