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



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:2/2/2018
Start Date:December 21, 2017
End Date:January 2019
Contact:Oleg Khatsenko
Email:projectmanager@therapeuticsinc.com
Phone:858-571-1800

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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

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


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.
We found this trial at
3
sites
Norfolk, Virginia 23507
Phone: 757-625-0151
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Saint Louis, Missouri 63110
Phone: 314-256-3436
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San Diego, California
Phone: 858-571-6800
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San Diego, CA
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