Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02530294 | Study of Glycopyrronium in Subjects With Axillary Hyperhidrosis | PHASE3 | COMPLETED | 353 | — | — | Aug 1, 2015 | Apr 1, 2016 | Aug 25, 2021 | 20 | United States |
| NCT02553798 | Long-term Safety Study of Glycopyrronium in Subjects With Primary Axillary Hyperhidrosis | PHASE3 | COMPLETED | 564 | — | — | Aug 1, 2015 | Dec 1, 2016 | Aug 25, 2021 | 48 | United States, Germany |
| NCT02530281 | Study of Glycopyrronium in Axillary Hyperhydrosis | PHASE3 | COMPLETED | 344 | — | — | Jul 1, 2015 | Mar 1, 2016 | Aug 25, 2021 | 31 | United States, Germany |
The Axillary Sweating Daily Diary (ASDD) is a 4-item instrument designed to measure the severity of axillary hyperhidrosis and its impact on daily activities. The 4 Items are: 1. During the past 24 hours, did you have any underarm sweating? (Yes or No) 2. During the past 24 hours, how would you rate your underarm sweating at its worst? (0=No sweating at all, 1, 2,…, 10=Worst possible sweating) 3. During the past 24 hours, to what extent did your underarm sweating impact your activities? (0=Not at all, 1=A little bit, 2=A moderate amount, 3=A great deal and 4=An extreme amount) 4. During the past 24 hours, how bothered were you by your underarm sweating? (0=Not at all bothered, 1=A little bothered, 2=Moderately bothered, 3=Very bothered, 4=Extremely bothered)
Subjects are acclimated to the environment for 30 minutes. Dry gauze is weighed. The dry gauze is then applied to the subject's axilla with the arm down by the subject's side or on their lap during the 5-minute period of sweat production. The gauze with the sweat is then weighed. The difference between the Weight of the gauze with sweat and the dry gauze is the gravimetric sweat measurement in mg/5min.
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
The Axillary Sweating Daily Diary (ASDD) is a 4-item instrument designed to measure the severity of axillary hyperhidrosis and its impact on daily activities. The 4 Items are: 1. During the past 24 hours, did you have any underarm sweating? (Yes or No) 2. During the past 24 hours, how would you rate your underarm sweating at its worst? (0=No sweating at all, 1, 2,…, 10=Worst possible sweating) 3. During the past 24 hours, to what extent did your underarm sweating impact your activities? (0=Not at all, 1=A little bit, 2=A moderate amount, 3=A great deal and 4=An extreme amount) 4. During the past 24 hours, how bothered were you by your underarm sweating? (0=Not at all bothered, 1=A little bothered, 2=Moderately bothered, 3=Very bothered, 4=Extremely bothered)
| Arm | Type | Description |
|---|---|---|
| glycopyrronium | EXPERIMENTAL | glycopyrronium Topical Wipes |
| Vehicle | PLACEBO_COMPARATOR | glycopyrronium Topical Wipes, Vehicle |
| Name | Type | Description |
|---|---|---|
| glycopyrronium Topical Wipes | DRUG | Topical wipes containing glycopyrronium |
| Vehicle | OTHER | Vehicle (placebo) topical wipes |
Inclusion Criteria: * Male or female ≥ 9 years of age. * Primary, axillary hyperhidrosis of at least 6 months duration. * Hyperhidrosis Disease Severity Scale (HDSS) of 3 or 4 at Baseline. * Axillary Sweating Daily Diary (ASDD) ≥ 4 at Baseline. * Sweat production of at least 50 mg over 5 minutes in...