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

Sponsor
Atacama Therapeutics (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04263623
Collaborator
(none)
75
Enrollment
1
Location
3
Arms
19
Anticipated Duration (Months)
3.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a multicenter, randomized, double-blind, placebo-controlled, parallel group comparison study of AT-5214 in subjects with moderate to severe primary palmar hyperhidrosis (sweaty palms). This study will compare two different oral (tablet) doses of AT-5214 (study drug) versus a matched placebo. Approximately 120 subjects will be enrolled at approximately 10 study sites.

Condition or Disease Intervention/Treatment Phase
  • Drug: Dexmecamylamine HCl
  • Other: Placebo
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
75 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Double-Blind, Randomized, Placebo-Controlled Study to Assess the Efficacy and Safety of AT-5214 in the Treatment of Subjects With Moderate to Severe Palmar Hyperhidrosis
Actual Study Start Date :
Jan 31, 2020
Actual Primary Completion Date :
Dec 3, 2020
Anticipated Study Completion Date :
Sep 1, 2021

Arms and Interventions

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 twice daily (in the morning and evening).

Drug: Dexmecamylamine HCl
Investigational drug
Other Names:
  • AT-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 twice daily (in the morning and evening).

    Drug: Dexmecamylamine HCl
    Investigational drug
    Other Names:
  • AT-5214

    		•
    Placebo Comparator: Placebo

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

    Other: Placebo
    Oral tablet containing no active drug.

    Outcome Measures

    Primary Outcome Measures

    1. PHIS Reduction [Week 6 (End of Study)]

      Proportion of subjects with at least a 2-point reduction in the Palmar Hyperhidrosis Impact Scale (PHIS) from their mean baseline value (rated on an 11-point scale, 0-10).

    Secondary Outcome Measures

    1. Absolute change in PHIS [Week 6 (End of Study)]

      Absolute change from the mean baseline value in PHIS

    2. Change in Sweat Production [Week 6 (End of Study)]

      Proportion of subjects with a ≥50% reduction from the mean baseline value in gravimetrically measured sweat production.

    3. Absolute change of Sweat Production [Week 6 (End of Study)]

      Absolute change from mean baseline value in gravimetrically measured sweat production.

    Other Outcome Measures

    1. Number of Subjects with Adverse Events (AEs) [Baseline (Day 1) to End of Study (Day 43)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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 user of nicotine products 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 prescription treatments for hyperhidrosis within four weeks prior to baseline visit.

    6. Any topical antiperspirant treatment to the palms within 7 days 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Site 01 Norfolk Virginia United States 23502

    Sponsors and Collaborators

    • Atacama Therapeutics

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Atacama Therapeutics
    ClinicalTrials.gov Identifier:
    NCT04263623
    Other Study ID Numbers:
    • 217-9951-202
    First Posted:
    Feb 11, 2020
    Last Update Posted:
    Jul 22, 2021
    Last Verified:
    Jul 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Atacama Therapeutics
    sweaty palms
    Additional relevant MeSH terms:
    Hyperhidrosis

    Study Results

    No Results Posted as of Jul 22, 2021