Clinical Study to Assess the Efficacy and Safety of AT-5214 in the Treatment of Subjects With Palmar Hyperhidrosis

Status unconfirmed · Phase 2 · Has a placebo group

Conditions studied: Hyperhidrosis, Palmar Hyperhidrosis

In brief

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.

Key facts

Study ID

NCT04263623

Run by

Atacama Therapeutics

People needed

75

Starts

2020-01-31

Expected to finish

2021-09-01

Last updated by the study team

2021-07-22

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject has a clinical diagnosis of primary hyperhidrosis of the palms
• Subject is currently drug-naïve for hyperhidrosis medications
• Females must be post-menopausal, surgically sterile, or use an effective method of birth control

You may not qualify if…

• Subject is pregnant, lactating, is planning to become pregnant during the study, or is less than one year postpartum.
• Subject is a user of nicotine products within one year prior to Visit 1/Screening.
• Subject has known history of secondary hyperhidrosis.
• Subject has existence of neurological, psychiatric, endocrine, or other disease that can cause secondary hyperhidrosis or affect sweating.
• Subject has known history of Sjögren's syndrome or Sicca syndrome.
• Subject has used any of the following hyperhidrosis medications or therapies within the specified timeframe:
• Iontophoresis to the palms within four weeks prior to baseline visit;
• Botulinum toxin to the palms within one year prior to baseline visit;
• Prior surgical procedures to the palms (e.g., sympathectomy, debulking of sweat glands);
• Prior medical device treatment to the palms (approved or investigational);
• Any prescription treatments for hyperhidrosis within four weeks prior to baseline visit.
• Any topical antiperspirant treatment to the palms within 7 days prior to baseline visit.
• Subject is currently enrolled in an investigational drug or device study.
• Subject has previously participated in a clinical study of dexmecamylamine or TC-5214.
• Subject has used an investigational drug or investigational device treatment within 30 days prior to baseline.

Where it is running

• Site 01 — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.