Peripheral NeuropathyNCT06312254
Pharmacological Modulation of Peripheral Nerve Excitability
A study testing Topical lidocaine 5%, Topical Phenytoin 10% and Topical Mepyramine 2% in people with Peripheral Neuropathy, run by Aalborg University at 1 site in Denmark.
Trial summary
The present project is a human experimental study. The aim is to assess the pharmacologically modulated excitability of peripheral sensory nerves with a human experimental model. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peripheral Neuropathy
- What is being tested?
- Topical lidocaine 5%, Topical Phenytoin 10% and Topical Mepyramine 2%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 9 Apr 2024to 11 Dec 2024
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and Women age > 18 years
- Understand and speak Danish
- No medication besides contraceptives
Who cannot join
- Pregnancy or lactating women
- Drug addiction (use of cannabis, opioids, or other drugs)
- Use of pain killers, alcohol, or nicotine within the last 24 hours before study start
- Any other medical treatment (e.g., antidepressants, anticonvulsants)
- History of peripheral or chronic pain conditions / neuropathy
- Skin diseases
Show all 12Show fewer
- Scars and/or tattoos at the volar site of the forearm
- Previous traumatic experience of an electrical accident
- Application of moisturizing lotion of the volar site of the forearms (24 hours before study start)
- Participation in any other research projects/studies 7 days before study start
- Known allergy/intolerance to lidocaine/phenytoin/mepyramine
- Lack of ability to cooperate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacological Modulation of Peripheral Nerve Excitability - Measurement With the Human Perception Threshold Tracking Method
The present project is a human experimental study. The aim is to assess the pharmacologically modulated excitability of peripheral sensory nerves with a human experimental model.
The study measures the excitability of peripheral sensory nerves before and after application of different topical drugs (lidocaine (5%), phenytoin (10%),mepyramine (2%) and placebo).
Read the detailed description
Design and method Study design The study is a randomized, double-blinded, placebo-controlled study. To minimize the risk of bias and achieve balance in the allocation of participants and application of creams, block randomization is used. To ensure double blinding, 1-2 colleagues from Center for Neuroplasticity and Pain (CNAP), who is not otherwise involved in the project, will keep the randomization list in a secure room.
Study procedure and experimental test The PTT model will be used to measure the excitability of peripheral sensory afferents. PTT will be measured before and after topical drug application at four distinct areas - two at each side of the volar site of the forearms.
In total four topical creams will be used in the study. One cream containing placebo, one with lidocaine (5%), one with phenytoin (10%) and one with mepyramine (2%).
The study consists of one session lasting 3-4 hrs. The study will include 20 healthy volunteers.
- Conditions
- Peripheral Neuropathy
- Being tested
- Topical lidocaine 5%, Topical Phenytoin 10%, Topical Mepyramine 2%, Topical Placebo
- Keywords
- Topical treatment, Small fiber excitability, Perception Threshold Tracking Method
- Medical subject headings
- Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical lidocaine 5%Drug
Drug is used to pharmacologically modulate peripheral sensory afferents
Topical Phenytoin 10%Drug
Drug is used to pharmacologically modulate peripheral sensory afferents
Topical Mepyramine 2%Drug
Drug is used to pharmacologically modulate peripheral sensory afferents
Topical PlaceboOther
Drug is used as control
| Study group | Role | What they receive |
|---|---|---|
| Pharmacological modulation with lidocaine 5% | Active comparator | Experimental investigation of pharmacological modulation of peripheral nerve excitability, which is measured with the human perception threshold tracking method. With this method neurophysiological mechanisms of sensory afferents can be investigated Receives: Drug: Topical lidocaine 5% |
| Pharmacological modulation with Phenytoin 10% | Active comparator | Experimental investigation of pharmacological modulation of peripheral nerve excitability, which is measured with the human perception threshold tracking method. With this method neurophysiological mechanisms of sensory afferents can be investigated Receives: Drug: Topical Phenytoin 10% |
| Pharmacological modulation with Mepyramine 2% | Active comparator | Experimental investigation of pharmacological modulation of peripheral nerve excitability, which is measured with the human perception threshold tracking method. With this method neurophysiological mechanisms of sensory afferents can be investigated Receives: Drug: Topical Mepyramine 2% |
| Control | Placebo comparator | Experimental investigation of pharmacological modulation of peripheral nerve excitability, which is measured with the human perception threshold tracking method. With this method neurophysiological mechanisms of sensory afferents can be investigated Receives: Other: Topical Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PTT-value
Primary outcome measures are changes in the PTT-value (registered as mA) before and after application with topical pharmaceutical drugs.
Measured: 1 hour after application of cream
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start9 Apr 2024
- Primary completion2 Dec 2024
- Study completion11 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral NeuropathyStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carsten Dahl Mørch, Aalborg University
- Investigators
- Trine Andresen, Post.Doc, Study director, Center for Neuroplasticity and Pain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06312254
- Sponsor's protocol ID
- N-20230071
- Status last verified
- Apr 2025
- First submitted
- 27 Feb 2024
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Andresen T, Tigerholm J, Roikjer J, Morch CD. Pharmacological modulation of peripheral nerve excitability-a novel way to investigate sodium channel subtypes in humans. Pain. 2026 Sep 9. doi: 10.1097/j.pain.0000000000004117. Online ahead of print.
PubMed 42751727
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacological Modulation of Peripheral Nerve Excitability - Measurement With the Human Perception Threshold Tracking Method
- ClinicalTrials.gov ID
- NCT06312254
- Acronym / sponsor ID
- N-20230071
- Conditions
- Peripheral Neuropathy
- Keywords
- Topical treatment, Small fiber excitability, Perception Threshold Tracking Method
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Study start
- 9 Apr 2024 (actual)
- Primary completion
- 2 Dec 2024 (actual)
- Study completion
- 11 Dec 2024 (actual)
- First posted
- 15 Mar 2024 (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.
The present project is a human experimental study. The aim is to assess the pharmacologically modulated excitability of peripheral sensory nerves with a human experimental model.
The study measures the excitability of peripheral sensory nerves before and after application of different topical drugs (lidocaine (5%), phenytoin (10%),mepyramine (2%) and placebo).
Detailed description
Design and method Study design The study is a randomized, double-blinded, placebo-controlled study. To minimize the risk of bias and achieve balance in the allocation of participants and application of creams, block randomization is used. To ensure double blinding, 1-2 colleagues from Center for Neuroplasticity and Pain (CNAP), who is not otherwise involved in the project, will keep the randomization list in a secure room.
Study procedure and experimental test The PTT model will be used to measure the excitability of peripheral sensory afferents. PTT will be measured before and after topical drug application at four distinct areas - two at each side of the volar site of the forearms.
In total four topical creams will be used in the study. One cream containing placebo, one with lidocaine (5%), one with phenytoin (10%) and one with mepyramine (2%).
The study consists of one session lasting 3-4 hrs. The study will include 20 healthy volunteers.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pharmacological modulation with lidocaine 5% | Active comparator | Drug: Topical lidocaine 5%Experimental investigation of pharmacological modulation of peripheral nerve excitability, which is measured with the human perception threshold tracking method. With this method neurophysiological mechanisms of sensory afferents can be investigated |
| Pharmacological modulation with Phenytoin 10% | Active comparator | Drug: Topical Phenytoin 10%Experimental investigation of pharmacological modulation of peripheral nerve excitability, which is measured with the human perception threshold tracking method. With this method neurophysiological mechanisms of sensory afferents can be investigated |
| Pharmacological modulation with Mepyramine 2% | Active comparator | Drug: Topical Mepyramine 2%Experimental investigation of pharmacological modulation of peripheral nerve excitability, which is measured with the human perception threshold tracking method. With this method neurophysiological mechanisms of sensory afferents can be investigated |
| Control | Placebo comparator | Other: Topical PlaceboExperimental investigation of pharmacological modulation of peripheral nerve excitability, which is measured with the human perception threshold tracking method. With this method neurophysiological mechanisms of sensory afferents can be investigated |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men and Women age > 18 years
- Understand and speak Danish
- No medication besides contraceptives
Key exclusion criteria (12 listed)
- Pregnancy or lactating women
- Drug addiction (use of cannabis, opioids, or other drugs)
- Use of pain killers, alcohol, or nicotine within the last 24 hours before study start
- Any other medical treatment (e.g., antidepressants, anticonvulsants)
- History of peripheral or chronic pain conditions / neuropathy
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 |
|---|---|---|
| Topical lidocaine 5%Drug is used to pharmacologically modulate peripheral sensory afferents | Drug | Pharmacological modulation with lidocaine 5% |
| Topical Phenytoin 10%Drug is used to pharmacologically modulate peripheral sensory afferents | Drug | Pharmacological modulation with Phenytoin 10% |
| Topical Mepyramine 2%Drug is used to pharmacologically modulate peripheral sensory afferents | Drug | Pharmacological modulation with Mepyramine 2% |
| Topical PlaceboDrug is used as control | Other | Control |
Primary outcome
Change in PTT-value
Time frame: 1 hour after application of cream
Primary outcome measures are changes in the PTT-value (registered as mA) before and after application with topical pharmaceutical drugs.
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 30 Apr 2025.
- Derived from this study: PubMed 42751727Andresen T, Tigerholm J, Roikjer J, Morch CD. Pharmacological modulation of peripheral nerve excitability-a novel way to investigate sodium channel subtypes in humans. Pain. 2026 Sep 9. doi: 10.1097/j.pain.0000000000004117. Online ahead of print.
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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.
Trine Andresen, Post.Doc study director
Center for Neuroplasticity and Pain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Topical lidocaine 5%, Topical Phenytoin 10% and Topical Mepyramine 2% in people with Peripheral Neuropathy, run by Aalborg University at 1 site in Denmark.
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 12 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 30 Apr 2025. 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 Denmark. 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.
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?
Change in PTT-value (time frame: 1 hour after application of cream). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06312254, which also lists 1 linked publication.
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 30 Apr 2025.