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Status unknownNCT04263623Updated Jul 22, 2021

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

A Phase 2 interventional study of Dexmecamylamine HCl and Placebo in Hyperhidrosis and Palmar Hyperhidrosis, sponsored by Atacama Therapeutics. Status unknown at 1 site in United States. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2021-07-22.

Sponsored by Atacama Therapeutics · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2021), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
75
Allocation
Randomized
Ages
16 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Hyperhidrosis
  • Palmar Hyperhidrosis

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Keywords

  • sweaty palms
03

In context

Hyperhidrosis

111 studies on the registry are indexed under Hyperhidrosis; 10 are open to participants now.

This study's enrollment of 75 is above the median of 50 across 99 interventional studies indexed under Hyperhidrosis.

Browse Hyperhidrosis studies →

Lead sponsor

Atacama Therapeutics is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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 );
    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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
75 participants (actual)

Study arms

  • 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

  • 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

  • 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).

    Other: Placebo

Interventions

  • DrugDexmecamylamine HCl

    Investigational drug

    Also known as: AT-5214

  • OtherPlacebo

    Oral tablet containing no active drug.

06

What researchers measure

Primary outcomes

  1. PHIS Reduction

    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).

    Time frame: Week 6 (End of Study)

Secondary outcomes

  1. Absolute change in PHIS

    Absolute change from the mean baseline value in PHIS

    Time frame: Week 6 (End of Study)

  2. Change in Sweat Production

    Proportion of subjects with a ≥50% reduction from the mean baseline value in gravimetrically measured sweat production.

    Time frame: Week 6 (End of Study)

  3. Absolute change of Sweat Production

    Absolute change from mean baseline value in gravimetrically measured sweat production.

    Time frame: Week 6 (End of Study)

Other outcomes

  1. Number of Subjects with Adverse Events (AEs)

    Time frame: Baseline (Day 1) to End of Study (Day 43)

07

Study locations

1 site
  • Site 01
    Norfolk, Virginia 23502, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2020 to primary completion in Dec 2020, 10 months.

Of 14 phase 2 interventional studies under Hyperhidrosis, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 11. This study's 10 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 7, 2020
First posted
Feb 11, 2020
StartActual
Jan 31, 2020
Primary completionActual
Dec 3, 2020
CompletionEst.
Sep 2021
Last update
Jul 22, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 22, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04263623
Lead sponsor
Atacama Therapeutics
Responsible party
Sponsor
First posted
Feb 11, 2020
Start date
Jan 31, 2020
Primary completion
Dec 3, 2020
Completion
Sep 2021 (estimated)
Last update
Jul 22, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Dexmecamylamine

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