HyperhidrosisPhase 2NCT04263623
Clinical Study to Assess the Efficacy and Safety of AT-5214 in the Treatment of Subjects With Palmar Hyperhidrosis
A Phase 2 study testing Dexmecamylamine HCl in people with Hyperhidrosis and Palmar Hyperhidrosis, run by Atacama Therapeutics at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Hyperhidrosis, Palmar Hyperhidrosis
- What is being tested?
- Dexmecamylamine HCl
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jan 2020to Sep 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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:
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Hyperhidrosis, Palmar Hyperhidrosis
- Being tested
- Dexmecamylamine HCl, Placebo
- Keywords
- sweaty palms
- Medical subject headings
- Hyperhidrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmecamylamine HClDrug
Also called AT-5214
Investigational drug
PlaceboOther
Oral tablet containing no active drug.
| Study group | Role | What they receive |
|---|---|---|
| High Dose (4 mg) | Experimental | 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). Receives: Drug: Dexmecamylamine HCl |
| Low Dose (2 mg) | Experimental | 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). Receives: Drug: Dexmecamylamine HCl |
| Placebo | Placebo comparator | Oral tablet containing no active drug. Subjects will be instructed to take two tablets by mouth twice daily (in the morning and evening). Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Week 6 (End of Study)
Secondary outcomes (3)
Absolute change in PHIS
Absolute change from the mean baseline value in PHIS
Measured: Week 6 (End of Study)
Change in Sweat Production
Proportion of subjects with a ≥50% reduction from the mean baseline value in gravimetrically measured sweat production.
Measured: Week 6 (End of Study)
Absolute change of Sweat Production
Absolute change from mean baseline value in gravimetrically measured sweat production.
Measured: Week 6 (End of Study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2020
- Study start31 Jan 2020
- Primary completion3 Dec 2020
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperhidrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atacama Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04263623
- Sponsor's protocol ID
- 217-9951-202
- Status last verified
- Jul 2021
- First submitted
- 7 Feb 2020
- Last updated
- 22 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04263623
- Acronym / sponsor ID
- 217-9951-202
- Conditions
- Hyperhidrosis, Palmar Hyperhidrosis
- Keywords
- sweaty palms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Atacama TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 31 Jan 2020 (actual)
- Primary completion
- 3 Dec 2020 (actual)
- Study completion
- Sep 2021 (estimated)
- First posted
- 11 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High Dose (4 mg) | Experimental | Drug: Dexmecamylamine HClOral 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). |
| Low Dose (2 mg) | Experimental | Drug: Dexmecamylamine HClOral 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). |
| Placebo | Placebo comparator | Other: PlaceboOral tablet containing no active drug. Subjects will be instructed to take two tablets by mouth twice daily (in the morning and evening). |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexmecamylamine HClAlso: AT-5214Investigational drug | Drug | High Dose (4 mg), Low Dose (2 mg) |
| PlaceboOral tablet containing no active drug. | Other | Placebo |
Primary outcome
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).
3 secondary outcomes
Absolute change in PHIS
Time frame: Week 6 (End of Study)
Change in Sweat Production
Time frame: Week 6 (End of Study)
Absolute change of Sweat Production
Time frame: Week 6 (End of Study)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dexmecamylamine HCl in people with Hyperhidrosis and Palmar Hyperhidrosis, run by Atacama Therapeutics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PHIS Reduction (time frame: Week 6 (End of Study)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2021.