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

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

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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