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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04263623
Other study ID # 217-9951-202
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date January 31, 2020
Est. completion date September 2021

Study information

Verified date July 2021
Source Atacama Therapeutics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 75
Est. completion date September 2021
Est. primary completion date December 3, 2020
Accepts healthy volunteers No
Gender All
Age group 16 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Dexmecamylamine HCl
Investigational drug
Other:
Placebo
Oral tablet containing no active drug.

Locations

Country Name City State
United States Site 01 Norfolk Virginia

Sponsors (1)

Lead Sponsor Collaborator
Atacama Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Number of Subjects with Adverse Events (AEs) Baseline (Day 1) to End of Study (Day 43)
Primary PHIS Reduction 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). Week 6 (End of Study)
Secondary Absolute change in PHIS Absolute change from the mean baseline value in PHIS Week 6 (End of Study)
Secondary Change in Sweat Production Proportion of subjects with a =50% reduction from the mean baseline value in gravimetrically measured sweat production. Week 6 (End of Study)
Secondary Absolute change of Sweat Production Absolute change from mean baseline value in gravimetrically measured sweat production. Week 6 (End of Study)
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