DOUBLE-BLIND, RANDOMISED, PLACEBO-CONTROLLED PROSPECTIVE MULTI-CENTRE PHASE III TRIAL TO ASSESS THE EFFICACY AND SAFETY OF METHANTHELINIUM BROMIDE (VAGANTIN®) IN THE TREATMENT OF FOCAL PALMAR-AXILLARY HYPERHIDROSIS

INTERVENTION: Trade Name: Vagantin® Pharmaceutical Form: Coated tablet INN or Proposed INN: Methanthelinium bromide CAS Number: 53‐46‐3 Concentration unit: mg milligram(s) Concentration type: equal Pharmaceutical form of the placebo: Coated tablet Route of administration of the placebo: Oral use CONDITION: Treatment of patients with axillary and palmar hyperhidrosis PRIMARY OUTCOME: Main Objective: Evaluation of the efficacy and safety of Vagantin® (methanthelinium bromide) in comparison to placebo in the treatment of axillary‐palmar hyperhidrosis.; Primary Target: axillary sweat gravimetry on day 28 +/‐ 1 Primary end point(s): axillary sweat gravimetry on day 28 +/‐ 1 day Secondary Objective: • axillary sweat gravimetry on day 14 +/‐ 1; • palmar sweat gravimetry on days 14 +/‐ 1 and 28 +/‐ 1; • hyperhidrosis disease severity scale (HDSS) on days 14 +/‐ 1 and 28 +/‐ 1; • dermatology life quality index (DLQI) on days 14 +/‐ 1 and 28 +/‐ 1; INCLUSION CRITERIA: Specific: • male and female patients, aged 18‐65 years • Caucasian origin • focal hyperhidrosis (axillary or focal palmar‐axillary, > 50 mg/5min both axillae and > 30 mg/5min both palms – palmar hyperhidrosis will only be assessed, if the condition >30 mg/5min is fulfilled) • duration of clinically manifested hyperhidrosis for at least 1 year • failure of at least one topical treatment course General: • written informed consent given by patient after being provided with detailed information about the nature, risks, and scope of the clinical trial as well as the expected desirable and adverse effects of the drug • female subjects of childbearing potential willing to use contraception during the study period (i.e. abstinence, oral contraception, intrauterine device, diaphragm, condom, spermicide, implant contraception, systemic contraception) or have secondary infertility or whose partner had a vasectomy, or female subjects of non childbea