Hyperhidrosis, Palmar Hyperhidrosis
Conditions
Keywords
sweaty palms
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.
Interventions
Investigational drug
OTHERPlacebo
Oral tablet containing no active drug.
Sponsors
Atacama Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Absolute change in PHIS | Week 6 (End of Study) | Absolute change from the mean baseline value in PHIS |
| 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. |
| Absolute change of Sweat Production | Week 6 (End of Study) | Absolute change from mean baseline value in gravimetrically measured sweat production. |
Other
| Measure | Time frame |
|---|---|
| Number of Subjects with Adverse Events (AEs) | Baseline (Day 1) to End of Study (Day 43) |
Countries
United States
Outcome results
None listed