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

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ClinicalTrials.gov Identifier: NCT04263623
Recruitment Status : Active, not recruiting
First Posted : February 11, 2020
Last Update Posted : May 11, 2021
Sponsor:
Information provided by (Responsible Party):
Atacama Therapeutics

Tracking Information
First Submitted Date  ICMJE February 7, 2020
First Posted Date  ICMJE February 11, 2020
Last Update Posted Date May 11, 2021
Actual Study Start Date  ICMJE January 31, 2020
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 10, 2020)
PHIS Reduction [ Time Frame: 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).
Original Primary Outcome Measures  ICMJE
 (submitted: February 7, 2020)
PHIS Reduction [ Time Frame: 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 10, 2020)
  • Absolute change in PHIS [ Time Frame: Week 6 (End of Study) ]
    Absolute change from the mean baseline value in PHIS
  • Change in Sweat Production [ Time Frame: Week 6 (End of Study) ]
    Proportion of subjects with a ≥50% reduction from the mean baseline value in gravimetrically measured sweat production.
  • Absolute change of Sweat Production [ Time Frame: Week 6 (End of Study) ]
    Absolute change from mean baseline value in gravimetrically measured sweat production.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 7, 2020)
  • Absolute change in PHIS [ Time Frame: Week 6 (End of Study) ]
    Absolute change from the mean baseline value in PHIS
  • Reduction in Sweat Production [ Time Frame: Week 6 (End of Study) ]
    Proportion of subjects with a ≥50% reduction from the mean baseline value in gravimetrically measured sweat production.
  • Absolute change of Sweat Production [ Time Frame: Week 6 (End of Study) ]
    Absolute change from mean baseline value in gravimetrically measured sweat production.
Current Other Pre-specified Outcome Measures
 (submitted: February 7, 2020)
Number of Subjects with Adverse Events (AEs) [ Time Frame: Baseline (Day 1) to End of Study (Day 43) ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Clinical Study to Assess the Efficacy and Safety of AT-5214 in the Treatment of Subjects With Palmar Hyperhidrosis
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Hyperhidrosis
  • Palmar Hyperhidrosis
Intervention  ICMJE
  • Drug: Dexmecamylamine HCl
    Investigational drug
    Other Name: AT-5214
  • Other: Placebo
    Oral tablet containing no active drug.
Study Arms  ICMJE
  • 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).
    Intervention: Drug: Dexmecamylamine HCl
  • 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).
    Intervention: Drug: Dexmecamylamine HCl
  • 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).
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: May 7, 2021)
75
Original Estimated Enrollment  ICMJE
 (submitted: February 7, 2020)
120
Estimated Study Completion Date  ICMJE June 2021
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04263623
Other Study ID Numbers  ICMJE 217-9951-202
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Atacama Therapeutics
Study Sponsor  ICMJE Atacama Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Atacama Therapeutics
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP