Comparator Study of the Effect of Glycopyrrolate and Glycopyrronium in Subjects With Axillary Hyperhidrosis

This is an interventional treatment trial for Hyperhidrosis Read More

Inclusion Criteria:

• Male or female, 18 years of age or older.
• Primary, axillary hyperhidrosis of at least 6 months duration.
• Hyperhidrosis Disease Severity Score (HDSS) of 3 or 4 at baseline.
• For each axilla, a baseline gravimetric measurement of sweat production of at least 50 mg over 5 minutes, while at rest, at room temperature.
• Male or non-pregnant, non-lactating females.

Exclusion Criteria:

• Current pregnancy or lactation.
• Prior surgical procedure for hyperhidrosis.
• Any prior axillary treatment with an anti-hyperhidrosis medical device
• Any prior treatment with an investigational drug within 4 weeks prior to Baseline/Day 1 or within 5 elimination half lives of the active agent, whichever is longer or 6 weeks if the elimination half life is not known. Experimental devices are excluded without the approval of the Medical Monitor.
• Prior treatment with botulinum toxin (e.g., Botox®) for axillary hyperhidrosis within 1 year of Baseline/Day 1.
• Subjects with clinically significant abnormalities in laboratory values.
• Subjects with a positive Hepatitis or HIV.Hepatitis B surface antibody positive is allowed only if the subject has a history of having received Hepatitis B vaccination and there are no clinically significant abnormalities in screening liver function tests.
• Treatment with cholinergic, serotonergic antagonists, and dopamine partial agonists thought to relieve antidepressant-induced hyperhidrosis, within one month prior to Baseline/Day 1.
• Treatment with psychotherapeutic medications for less than 4 months prior to Baseline/Day 1.
• Treatment with topical or systemic anticholinergics, adrenergic agonists (clonidine), or beta-blockers within 4 weeks of the baseline visit
• Prior treatment with axillary iontophoresis within 4 weeks of Baseline/Day 1.
• Any previous IV or oral treatment with the study drug.
• Prior treatment with the topical study drug in a previous trial.
• Axillary use of nonprescription or prescription antiperspirants within 2 weeks of study enrollment.
• Presence of a condition, within 10 years of enrollment, that may cause secondary hyperhidrosis
• Menopausal women who have had symptoms of menopause such as sweating or flushing within 3 years of the study may not be enrolled.
• Known history of Sjögren's syndrome or Sicca syndrome.
• History of glaucoma, inflammatory bowel disease, toxic megacolon, or febrile illness.
• Men with a history of urinary retention requiring catheterization due to prostatic hypertrophy or severe obstructive symptoms of prostatic hypertrophy.
• Abnormal findings on screening ECG deemed clinically significant by the Investigator.
• History or presence of ventricular arrhythmias, atrial fibrillation, atrial flutter. History of other supraventricular tachycardia