Exploratory Study to Assess the Efficacy and Safety of TC-5214 in the Treatment of Subjects With Palmar Hyperhidrosis
Completed · Phase 2 · Has a placebo group
Conditions studied: Palmar Hyperhidrosis
In brief
This is a pilot exploratory study to evaluate the safety and efficacy of TC-5214 in subjects with palmar hyperhidrosis.
Key facts
- Study ID
- NCT03404570
- Run by
- Atacama Therapeutics
- People needed
- 60
- Starts
- 2017-12-21
- Expected to finish
- 2019-01-18
- Last updated by the study team
- 2019-11-21
Who can join
Age: 18 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 smoker 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 treatments for hyperhidrosis within four weeks 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.
- Subject has a history of sensitivity to any of the ingredients in the study drugs.
Where it is running
- Site 02 — San Diego, California, United States
- Site 03 — St Louis, Missouri, United States
- Site 01 — Norfolk, Virginia, United States
Full record on ClinicalTrials.gov
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