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

A

Atacama Therapeutics

Status and phase

Completed
Phase 2

Conditions

Palmar Hyperhidrosis

Treatments

Other: Placebo
Drug: Dexmecamylamine HCl

Study type

Interventional

Funder types

Industry

Identifiers

NCT03404570
217-9951-201

Details and patient eligibility

About

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

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

60 participants in 3 patient groups, including a placebo group

High Dose (4 mg)
Experimental group
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).
Treatment:
Drug: Dexmecamylamine HCl
Low Dose (2 mg)
Experimental group
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).
Treatment:
Drug: Dexmecamylamine HCl
Placebo
Placebo Comparator group
Description:
Oral tablet containing no active drug. Subjects will be instructed to take two tablets by mouth once daily (in the morning).
Treatment:
Other: Placebo

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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