This is a pilot exploratory study to evaluate the safety and efficacy of TC-5214 in subjects with palmar hyperhidrosis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
Investigational drug
Oral tablet containing no active drug.
Site 02
San Diego, California, United States
Site 03
St Louis, Missouri, United States
Site 01
Norfolk, Virginia, United States
HDSS Success
Proportion of subjects with at least a 1, 2, or 3 point reduction in Hyperhidrosis Disease Severity Scale (HDSS) score from Baseline
Time frame: Day 14 (End of Treatment)
Reduction in Sweat Production
Proportion of subjects with a ≥50% reduction in gravimetrically measured sweat production
Time frame: Day 14 (End of Treatment)
Absolute change of Sweat Production
Absolute change from Baseline in gravimetrically measured sweat production.
Time frame: Day 14 (End of Treatment)
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