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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
75
Investigational drug
Oral tablet containing no active drug.
Site 01
Norfolk, Virginia, United States
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).
Time frame: Week 6 (End of Study)
Absolute change in PHIS
Absolute change from the mean baseline value in PHIS
Time frame: Week 6 (End of Study)
Change in Sweat Production
Proportion of subjects with a ≥50% reduction from the mean baseline value in gravimetrically measured sweat production.
Time frame: Week 6 (End of Study)
Absolute change of Sweat Production
Absolute change from mean baseline value in gravimetrically measured sweat production.
Time frame: Week 6 (End of Study)
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