Palmar HyperhidrosisPhase 2NCT03404570
Exploratory Study to Assess the Efficacy and Safety of TC-5214 in the Treatment of Subjects With Palmar Hyperhidrosis
A Phase 2 study testing Dexmecamylamine HCl in people with Palmar Hyperhidrosis, run by Atacama Therapeutics at 3 sites in United States.
Trial summary
This is a pilot exploratory study to evaluate the safety and efficacy of TC-5214 in subjects with palmar hyperhidrosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- 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
- 60 participants
- Where
- 3 sitesUnited States
- Study dates
- 21 Dec 2017to 18 Jan 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- 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 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:
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 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Site 01
Norfolk, Virginia, 23502
Site 02
San Diego, California, 92123
Site 03
St Louis, Missouri, 63122
About this study
Official title: A Double-Blind, Randomized, Placebo-Controlled Exploratory Study to Assess the Efficacy and Safety of TC-5214 in the Treatment of Subjects With Moderate to Severe Palmar Hyperhidrosis
This is a pilot exploratory study to evaluate the safety and efficacy of TC-5214 in subjects with palmar hyperhidrosis.
- Conditions
- Palmar Hyperhidrosis
- Being tested
- Dexmecamylamine HCl, Placebo
- Keywords
- Sweaty Hands
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmecamylamine HClDrug
Also called TC-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 once daily (in the morning). 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 once daily (in the morning). Receives: Drug: Dexmecamylamine HCl |
| Placebo | Placebo comparator | Oral tablet containing no active drug. Subjects will be instructed to take two tablets by mouth once daily (in the morning). Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
HDSS Success
Proportion of subjects with at least a 1, 2, or 3 point reduction in Hyperhidrosis Disease Severity Scale (HDSS) score from Baseline
Measured: Day 14 (End of Treatment)
Secondary outcomes (2)
Reduction in Sweat Production
Proportion of subjects with a ≥50% reduction in gravimetrically measured sweat production
Measured: Day 14 (End of Treatment)
Absolute change of Sweat Production
Absolute change from Baseline in gravimetrically measured sweat production.
Measured: Day 14 (End of Treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2018
- Study start21 Dec 2017
- Primary completion18 Jan 2019
- Study completion18 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Palmar 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
- Model description
- Subjects will be randomized (1:1:1) to one of three Treatment Arms
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 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
- NCT03404570
- Sponsor's protocol ID
- 217-9951-201
- Status last verified
- Nov 2019
- First submitted
- 22 Dec 2017
- Last updated
- 21 Nov 2019
- 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 21 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Placebo-Controlled Exploratory Study to Assess the Efficacy and Safety of TC-5214 in the Treatment of Subjects With Moderate to Severe Palmar Hyperhidrosis
- ClinicalTrials.gov ID
- NCT03404570
- Acronym / sponsor ID
- 217-9951-201
- Conditions
- Palmar Hyperhidrosis
- Keywords
- Sweaty Hands
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Atacama TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 21 Dec 2017 (actual)
- Primary completion
- 18 Jan 2019 (actual)
- Study completion
- 18 Jan 2019 (actual)
- First posted
- 19 Jan 2018 (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 pilot exploratory study to evaluate the safety and efficacy of TC-5214 in subjects with palmar hyperhidrosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Subjects will be randomized (1:1:1) to one of three Treatment Arms
| 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 once daily (in the morning). |
| 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 once daily (in the morning). |
| Placebo | Placebo comparator | Other: PlaceboOral tablet containing no active drug. Subjects will be instructed to take two tablets by mouth once daily (in the morning). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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 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.
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: TC-5214Investigational drug | Drug | High Dose (4 mg), Low Dose (2 mg) |
| PlaceboOral tablet containing no active drug. | Other | Placebo |
Primary outcome
HDSS Success
Time frame: Day 14 (End of Treatment)
Proportion of subjects with at least a 1, 2, or 3 point reduction in Hyperhidrosis Disease Severity Scale (HDSS) score from Baseline
2 secondary outcomes
Reduction in Sweat Production
Time frame: Day 14 (End of Treatment)
Absolute change of Sweat Production
Time frame: Day 14 (End of Treatment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2019.
- 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.
3 sites 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 Palmar Hyperhidrosis, run by Atacama Therapeutics at 3 sites 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: finished, as of the sponsor's last update on 21 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
HDSS Success (time frame: Day 14 (End of Treatment)). 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 21 Nov 2019.