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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 : July 22, 2021
Sponsor:
Information provided by (Responsible Party):
Atacama Therapeutics

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
Hyperhidrosis Palmar Hyperhidrosis Drug: Dexmecamylamine HCl Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
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 : January 31, 2020
Actual Primary Completion Date : December 3, 2020
Estimated Study Completion Date : September 2021

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 Name: 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 Name: 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.




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. Absolute change in PHIS [ Time Frame: Week 6 (End of Study) ]
    Absolute change from the mean baseline value in PHIS

  2. 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.

  3. Absolute change of Sweat Production [ Time Frame: 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) [ Time Frame: Baseline (Day 1) to End of Study (Day 43) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, 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 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.

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): NCT04263623


Locations
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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: NCT04263623    
Other Study ID Numbers: 217-9951-202
First Posted: February 11, 2020    Key Record Dates
Last Update Posted: July 22, 2021
Last Verified: July 2021
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 palms
Additional relevant MeSH terms:
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Hyperhidrosis
Sweat Gland Diseases
Skin Diseases