Back to resultsClinical Study to Assess the Efficacy and Safety of AT-5214 in the Treatment of Subjects With Palmar Hyperhidrosis
Primary Purpose
Hyperhidrosis, Palmar Hyperhidrosis
Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Dexmecamylamine HCl
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hyperhidrosis focused on measuring sweaty palms
Eligibility 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:
- Iontophoresis to the palms within four weeks prior to baseline visit;
- Botulinum toxin to the palms within one year prior to baseline visit;
- Prior surgical procedures to the palms (e.g., sympathectomy, debulking of sweat glands);
- Prior medical device treatment to the palms (approved or investigational);
- Any prescription treatments for hyperhidrosis within four weeks prior to baseline visit.
- 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.
Sites / Locations
- Site 01
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
High Dose (4 mg)
Low Dose (2 mg)
Placebo
Arm Description
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).
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).
Oral tablet containing no active drug. Subjects will be instructed to take two tablets by mouth twice daily (in the morning and evening).
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Absolute change in PHIS
Absolute change from the mean baseline value in PHIS
Change in Sweat Production
Proportion of subjects with a ≥50% reduction from the mean baseline value in gravimetrically measured sweat production.
Absolute change of Sweat Production
Absolute change from mean baseline value in gravimetrically measured sweat production.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04263623
Brief Title
Clinical Study to Assess the Efficacy and Safety of AT-5214 in the Treatment of Subjects With Palmar Hyperhidrosis
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 31, 2020 (Actual)
Primary Completion Date
December 3, 2020 (Actual)
Study Completion Date
September 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Atacama Therapeutics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperhidrosis, Palmar Hyperhidrosis
Keywords
sweaty palms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High Dose (4 mg)
Arm Type
Experimental
Arm Description
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).
Arm Title
Low Dose (2 mg)
Arm Type
Experimental
Arm Description
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).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Oral tablet containing no active drug. Subjects will be instructed to take two tablets by mouth twice daily (in the morning and evening).
Intervention Type
Drug
Intervention Name(s)
Dexmecamylamine HCl
Other Intervention Name(s)
AT-5214
Intervention Description
Investigational drug
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Oral tablet containing no active drug.
Primary Outcome Measure Information:
Title
PHIS Reduction
Description
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).
Time Frame
Week 6 (End of Study)
Secondary Outcome Measure Information:
Title
Absolute change in PHIS
Description
Absolute change from the mean baseline value in PHIS
Time Frame
Week 6 (End of Study)
Title
Change in Sweat Production
Description
Proportion of subjects with a ≥50% reduction from the mean baseline value in gravimetrically measured sweat production.
Time Frame
Week 6 (End of Study)
Title
Absolute change of Sweat Production
Description
Absolute change from mean baseline value in gravimetrically measured sweat production.
Time Frame
Week 6 (End of Study)
Other Pre-specified Outcome Measures:
Title
Number of Subjects with Adverse Events (AEs)
Time Frame
Baseline (Day 1) to End of Study (Day 43)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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:
Iontophoresis to the palms within four weeks prior to baseline visit;
Botulinum toxin to the palms within one year prior to baseline visit;
Prior surgical procedures to the palms (e.g., sympathectomy, debulking of sweat glands);
Prior medical device treatment to the palms (approved or investigational);
Any prescription treatments for hyperhidrosis within four weeks prior to baseline visit.
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.
Facility Information:
Facility Name
Site 01
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Study to Assess the Efficacy and Safety of AT-5214 in the Treatment of Subjects With Palmar Hyperhidrosis
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