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Trial record 1 of 1 for:    TC-5214 in the Treatment of Subjects With Palmar Hyperhidrosis
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Exploratory Study to Assess the Efficacy and Safety of TC-5214 in the Treatment of Subjects With Palmar Hyperhidrosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03404570
Recruitment Status : Completed
First Posted : January 19, 2018
Last Update Posted : November 21, 2019
Sponsor:
Information provided by (Responsible Party):
Atacama Therapeutics

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

Condition or disease Intervention/treatment Phase
Palmar Hyperhidrosis Drug: Dexmecamylamine HCl Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Subjects will be randomized (1:1:1) to one of three Treatment Arms
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: The study drug will be provided as oral tablets with active and placebo indistinguishable in product and packing characteristics.
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : December 21, 2017
Actual Primary Completion Date : January 18, 2019
Actual Study Completion Date : January 18, 2019

Arm Intervention/treatment
Experimental: High Dose (4 mg)
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
Investigational drug
Other Name: TC-5214

Experimental: Low Dose (2 mg)
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
Investigational drug
Other Name: TC-5214

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




Primary Outcome Measures :
  1. HDSS Success [ Time Frame: Day 14 (End of Treatment) ]
    Proportion of subjects with at least a 1, 2, or 3 point reduction in Hyperhidrosis Disease Severity Scale (HDSS) score from Baseline


Secondary Outcome Measures :
  1. Reduction in Sweat Production [ Time Frame: Day 14 (End of Treatment) ]
    Proportion of subjects with a ≥50% reduction in gravimetrically measured sweat production

  2. Absolute change of Sweat Production [ Time Frame: Day 14 (End of Treatment) ]
    Absolute change from Baseline in gravimetrically measured sweat production.


Other Outcome Measures:
  1. Number of Subjects with Adverse Events (AEs) [ Time Frame: From Baseline (Day 1) to End of Study (Day 22) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03404570


Locations
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United States, California
Site 02
San Diego, California, United States, 92123
United States, Missouri
Site 03
Saint Louis, Missouri, United States, 63122
United States, Virginia
Site 01
Norfolk, Virginia, United States, 23502
Sponsors and Collaborators
Atacama Therapeutics

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Responsible Party: Atacama Therapeutics
ClinicalTrials.gov Identifier: NCT03404570    
Other Study ID Numbers: 217-9951-201
First Posted: January 19, 2018    Key Record Dates
Last Update Posted: November 21, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Atacama Therapeutics:
Sweaty Hands
Additional relevant MeSH terms:
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Hyperhidrosis
Sweat Gland Diseases
Skin Diseases