Trials Sponsors Conditions Drugs Pricing

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).

Interventions

Dexmecamylamine HClDrug

Investigational drug

Also known as: TC-5214

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

PlaceboOther

Oral tablet containing no active drug.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (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

Sponsors & Collaborators

Atacama Therapeutics
Industrylead

Study Sites (3)

Site 02

San Diego, California, 92123, United States

Site 03

St Louis, Missouri, 63122, United States

Site 01

Norfolk, Virginia, 23502, United States

Enrollment

60 participants (actual enrollment reported by the registry).

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

Study Record Dates

First Submitted

December 22, 2017

First Posted

January 19, 2018

Study Start

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Other Outcomes (1)

Study Arms (3)

High Dose (4 mg)

Low Dose (2 mg)

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (3)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Other Outcomes (1)

Study Arms (3)

High Dose (4 mg)

Low Dose (2 mg)

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (3)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations