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

NCT03404570 | Completed Phase 2 FDA Drug

• 1 other identifier: 217-9951-201
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Palmar Hyperhidrosis

Keywords

Sweaty Hands

Outcome Measures

Primary Outcomes (1)

• HDSS Success

  Proportion of subjects with at least a 1, 2, or 3 point reduction in Hyperhidrosis Disease Severity Scale (HDSS) score from Baseline

  Day 14 (End of Treatment)

Secondary Outcomes (2)

• Reduction in Sweat Production

  Day 14 (End of Treatment)

• Absolute change of Sweat Production

  Day 14 (End of Treatment)

Other Outcomes (1)

• Number of Subjects with Adverse Events (AEs)

  From Baseline (Day 1) to End of Study (Day 22)

Study Arms (3)

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).

Drug: Dexmecamylamine HCl

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).

Drug: Dexmecamylamine HCl

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Dexmecamylamine HCl DRUG

Investigational drug

Also known as: TC-5214

High Dose (4 mg); Low Dose (2 mg)

Placebo OTHER

Oral tablet containing no active drug.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Atacama Therapeutics: lead

Study Sites (3)

Site 02

San Diego, California, 92123, United States

Location

Site 03

St Louis, Missouri, 63122, United States

Location

Site 01

Norfolk, Virginia, 23502, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study drug will be provided as oral tablets with active and placebo indistinguishable in product and packing characteristics.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects will be randomized (1:1:1) to one of three Treatment Arms

Study Record Dates

• First Submitted: December 22, 2017
• First Posted: January 19, 2018
• Study Start: December 21, 2017
• Primary Completion: January 18, 2019
• Study Completion: January 18, 2019
• Last Updated: November 21, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)