Clinical trial NCT04263623: Clinical Study to Assess the Efficacy and Safety of AT-5214 in the Treatment of Subjects With Palmar Hyperhidrosis
Official title: A Double-Blind, Randomized, Placebo-Controlled Study to Assess the Efficacy and Safety of AT-5214 in the Treatment of Subjects With Moderate to Severe Palmar Hyperhidrosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Hyperhidrosis
Palmar Hyperhidrosis
Keywords: sweaty palms
Lead sponsor: Atacama Therapeutics
Sponsor class: INDUSTRY
First posted: 2020-02-11
Enrollment: 75
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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:

  1. Iontophoresis to the palms within four weeks prior to baseline visit;
  2. Botulinum toxin to the palms within one year prior to baseline visit;
  3. Prior surgical procedures to the palms (e.g., sympathectomy, debulking of sweat glands);
  4. Prior medical device treatment to the palms (approved or investigational);
  5. Any prescription treatments for hyperhidrosis within four weeks prior to baseline visit.
  6. 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.

Primary outcomes:
measure: PHIS Reduction
timeFrame: Week 6 (End of Study)
Secondary outcomes:
measure: Absolute change in PHIS
timeFrame: Week 6 (End of Study)
measure: Change in Sweat Production
timeFrame: Week 6 (End of Study)
measure: Absolute change of Sweat Production
timeFrame: Week 6 (End of Study)
Other outcomes:
measure: Number of Subjects with Adverse Events (AEs)
timeFrame: Baseline (Day 1) to End of Study (Day 43)
Locations:
city: Norfolk
country: United States
facility: Site 01
state: Virginia
Study officials:
References: