Clinical Study to Assess the Efficacy and Safety of AT-5214 in the Treatment of Subjects With Palmar Hyperhidrosis
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|ClinicalTrials.gov Identifier: NCT04263623|
Recruitment Status : Active, not recruiting
First Posted : February 11, 2020
Last Update Posted : July 22, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Hyperhidrosis Palmar Hyperhidrosis||Drug: Dexmecamylamine HCl Other: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||75 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Actual Study Start Date :||January 31, 2020|
|Actual Primary Completion Date :||December 3, 2020|
|Estimated Study Completion Date :||September 2021|
Experimental: High Dose (4 mg)
Oral tablet containing 2 mg of active drug, dexmecamylamine HCl. Subjects will be instructed to take two tablets by mouth twice daily (in the morning and evening).
Drug: Dexmecamylamine HCl
Other Name: AT-5214
Experimental: Low Dose (2 mg)
Oral tablet containing 1 mg of active drug, dexmecamylamine HCl. Subjects will be instructed to take two tablets by mouth twice daily (in the morning and evening).
Drug: Dexmecamylamine HCl
Other Name: AT-5214
Placebo Comparator: Placebo
Oral tablet containing no active drug. Subjects will be instructed to take two tablets by mouth twice daily (in the morning and evening).
Oral tablet containing no active drug.
- PHIS Reduction [ Time Frame: Week 6 (End of Study) ]Proportion of subjects with at least a 2-point reduction in the Palmar Hyperhidrosis Impact Scale (PHIS) from their mean baseline value (rated on an 11-point scale, 0-10).
- Absolute change in PHIS [ Time Frame: Week 6 (End of Study) ]Absolute change from the mean baseline value in PHIS
- Change in Sweat Production [ Time Frame: Week 6 (End of Study) ]Proportion of subjects with a ≥50% reduction from the mean baseline value in gravimetrically measured sweat production.
- Absolute change of Sweat Production [ Time Frame: Week 6 (End of Study) ]Absolute change from mean baseline value in gravimetrically measured sweat production.
- Number of Subjects with Adverse Events (AEs) [ Time Frame: Baseline (Day 1) to End of Study (Day 43) ]
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|Ages Eligible for Study:||16 Years and older (Child, Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04263623
|United States, Virginia|
|Norfolk, Virginia, United States, 23502|
|Responsible Party:||Atacama Therapeutics|
|Other Study ID Numbers:||
|First Posted:||February 11, 2020 Key Record Dates|
|Last Update Posted:||July 22, 2021|
|Last Verified:||July 2021|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Sweat Gland Diseases