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Parkinson's DiseasePhase 2NCT07294469

Menthol for Improving Movement and Sleep in Parkinson's Disease Patients

A Phase 2 study testing Menthol gloves and socks in people with Parkinson's Disease, run by Taipei Medical University Hospital at 1 site in Taiwan.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Parkinson's disease (PD) is a progressive neurological disorder characterized by both motor and non-motor symptoms due to the degeneration of dopamine-producing neurons. There is currently no cure. Read more about this study

Who is it for?
Ages 30 to 80 years
Conditions the study is for
Parkinson's Disease
What is being tested?
Menthol gloves and socks
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
80 participants
Where
1 siteTaiwan
Study dates
15 Dec 2025to 31 Jul 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 30 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • aged between 30 and 80 years (inclusive);
  • diagnosed with idiopathic PD based on the Brain Bank criteria of the UK Parkinson's Disease Society less than 3 years;
  • Hoehn and Yahr stages 1-3 and currently receiving treatment; experiencing sleep disorders with a Pittsburgh Sleep Quality Index (PSQI) > 5;
  • has signed the informed consent form approved by the Institutional Review Board and dated accordingly;
  • no changes in PD medications within four weeks prior to participating in this trial, and no dosage changes during the study period;
  • able to use other medications that may affect sleep, except those explicitly prohibited, provided the dosage has been stable for the four weeks before screening and remains unchanged during the study.

Who cannot join

  • menthol allergy;
  • pregnant and breastfeeding women;
  • diagnosed with secondary and atypical PD;
  • patients with conditions such as uremia, cirrhosis, congestive heart failure with pulmonary edema, coagulation disorders, epilepsy, alcoholism, drug abuse, or
  • deemed unsuitable for participation in this study by the principal investigator.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Hsun-Hua Lee, MD-PhD contact

(886)02-27372181

kaorulei@yahoo.com.tw

Taiwan1 site
  • Taipei Medical University Hospital

    Taipei

    Hsun-Hua Lee, MD-PhD, (886)02-27372181, kaorulei@yahoo.com.tw

Other trials in Taiwan

About this study

Official title: Effect of Menthol on Motor Deficits and Sleep Disturbances in Patients With Parkinson's Disease

Parkinson's disease (PD) is a progressive neurological disorder characterized by both motor and non-motor symptoms due to the degeneration of dopamine-producing neurons. There is currently no cure. Menthol, a natural compound that activates TRPM8 receptors, has shown neuroprotective and motor function benefits in preclinical PD models. In mice, distal limb immersion in menthol improved dopamine neuron survival and motor performance. Similar menthol-based interventions improved outcomes in a stroke model and a clinical trial with stroke patients. This study investigates whether topical menthol can offer therapeutic benefits for individuals with PD.

Read the detailed description

Parkinson's disease (PD) is a progressive neurological disorder that affects both motor and non-motor functions, with symptoms that can vary widely in severity. It is caused by the degeneration of dopamine-producing neurons in the substantia nigra, a brain region essential for movement control. The characteristic motor symptoms of PD include tremor, rigidity, bradykinesia, and postural instability. In addition to these motor impairments, many individuals with PD also experience non-motor symptoms, such as sleep disturbances, which can significantly impact their quality of life. Unfortunately, there is currently no cure for PD.

Menthol, a naturally occurring compound found in peppermint essential oil, has been shown to activate TRPM8 receptors in somatosensory neurons. Pharmacological activation of peripheral TRPM8 receptors enhances neural activity, which is subsequently transmitted to the brain.

In previous preclinical studies, the investigators used a dopamine toxin-induced PD mouse model and treated the mice with distal limb immersion in menthol. The results of immunohistochemical staining showed that limb immersion in menthol reduced the loss of dopamine neurons and increased the dopamine content in the mouse striatum. The mice's motor function also improved, as indicated by a significant increase in the time they spent running on the rotarod. The investigators also evaluated the effects of menthol in a stroke mouse model induced by MCAO. Topical application of menthol to the paw alleviated acute cerebral infarction and ischemia-induced sensorimotor deficits in MCAO mice.

In our recent clinical trial, the investigators evaluated the effects of menthol-containing gloves and socks in acute ischemic stroke patients. After four weeks of treatment, patients showed improvements in their Modified Rankin Scale (mRS) and Barthel Index (BI) scores, suggesting that this intervention may help enhance functional recovery. Based on these promising results, the investigators hypothesize that a similar approach could benefit individuals with PD.

The investigators aim to conduct a double-blind, randomized controlled trial evaluating the effectiveness of menthol-containing gloves and socks in treating motor deficits and sleep disorders in patients with PD:A total of 80 patients with PD will be randomized into the following groups: (1) menthol-containing gloves and socks (2) placebo. The treatment duration will be 4 weeks, with 4 weeks follow-up. All patients will be clinically assessed at the randomization, 4 and 8 week. Unified Parkinson's Disease Rating Scale (UPDRS) I,II,III, Pittsburgh Sleep Quality Index (PSQI), Parkinson's Disease Sleep Scale-2 (PDSS-2), Parkinson's Disease Questionnaire (PDQ-39) and detailed neurological examination will be included in the assessment.

Being tested
Menthol gloves and socks, Placebo gloves and socks
Keywords
Menthol, Parkinson's Disease, Motor Deficits, Sleep Disturbances
Medical subject headings
Parkinson Disease, Neurologic Manifestations, Parasomnias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Menthol gloves and socksDrug

    Participants will wear menthol-containing gloves and socks for five minutes per day, five days a week, over a four-week period.

  • Placebo gloves and socksDrug

    Participants will wear gloves and socks with plain lotion for five minutes per day, five days a week, over a four-week period.

Study groups in NCT07294469
Study groupRoleWhat they receive
Menthol GroupExperimentalParticipants in this arm will wear gloves and socks containing menthol daily for four weeks.
Receives: Drug: Menthol gloves and socks
Placebo GroupPlacebo comparatorParticipants in this arm will wear placebo gloves and socks daily for four weeks. These are identical in appearance and material to those used in the treatment group but contain no active menthol compound.
Receives: Drug: Placebo gloves and socks

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Unified Parkinson's Disease Rating Scale (UPDRS) I,II,III

    The UPDRS is a clinical tool to assess the severity of Parkinson's disease. It consists of:

    Part I: Mentation, Behavior, and Mood (cognitive and psychiatric symptoms); Part II: Activities of Daily Living (self-reported motor activities); Part III: Motor Examination (clinician-assessed motor symptoms); The combined score of Parts I, II, and III reflects overall disease severity.

    Measured: Evaluations will be conducted at the time of randomization and will serve as baseline data.

  2. Unified Parkinson's Disease Rating Scale (UPDRS) I,II,III

    The UPDRS is a clinical tool to assess the severity of Parkinson's disease. It consists of:

    Part I: Mentation, Behavior, and Mood (cognitive and psychiatric symptoms); Part II: Activities of Daily Living (self-reported motor activities); Part III: Motor Examination (clinician-assessed motor symptoms); The combined score of Parts I, II, and III reflects overall disease severity.

    Measured: Evaluations will be conducted at the fourth week after the start of the intervention.

  3. Unified Parkinson's Disease Rating Scale (UPDRS) I,II,III

    The UPDRS is a clinical tool to assess the severity of Parkinson's disease. It consists of:

    Part I: Mentation, Behavior, and Mood (cognitive and psychiatric symptoms); Part II: Activities of Daily Living (self-reported motor activities); Part III: Motor Examination (clinician-assessed motor symptoms); The combined score of Parts I, II, and III reflects overall disease severity.

    Measured: Evaluations will be conducted at the fourth week after the end of the intervention, i.e. the eighth week after start of intervention.

  4. Pittsburgh Sleep Quality Index (PSQI)

    The PSQI is a self-report questionnaire assessing sleep quality and disturbances over the past month. It consists of 19 items across 7 domains: sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction.

    Measured: Evaluations will be conducted at the time of randomization and will serve as baseline data.

  5. Pittsburgh Sleep Quality Index (PSQI)

    The PSQI is a self-report questionnaire assessing sleep quality and disturbances over the past month. It consists of 19 items across 7 domains: sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction.

    Measured: Evaluations will be conducted at the fourth week after the start of the intervention.

  6. Pittsburgh Sleep Quality Index (PSQI)

    The PSQI is a self-report questionnaire assessing sleep quality and disturbances over the past month. It consists of 19 items across 7 domains: sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction.

    Measured: Evaluations will be conducted at the fourth week after the end of the intervention, i.e. the eighth week after start of intervention.

Secondary outcomes (6)
  1. Parkinson's Disease Sleep Scale-2 (PDSS-2)

    The PDSS-2 is a self-reported tool designed to assess sleep disturbances specifically in individuals with Parkinson's disease. It includes 15 items covering various sleep-related issues such as sleep onset, duration, nocturnal motor symptoms, and daytime sleepiness.

    Measured: Evaluations will be conducted at the time of randomization and will serve as baseline data.

  2. Parkinson's Disease Sleep Scale-2 (PDSS-2)

    The PDSS-2 is a self-reported tool designed to assess sleep disturbances specifically in individuals with Parkinson's disease. It includes 15 items covering various sleep-related issues such as sleep onset, duration, nocturnal motor symptoms, and daytime sleepiness.

    Measured: Evaluations will be conducted at the fourth week after the start of the intervention.

  3. Parkinson's Disease Sleep Scale-2 (PDSS-2)

    The PDSS-2 is a self-reported tool designed to assess sleep disturbances specifically in individuals with Parkinson's disease. It includes 15 items covering various sleep-related issues such as sleep onset, duration, nocturnal motor symptoms, and daytime sleepiness.

    Measured: Evaluations will be conducted at the fourth week after the end of the intervention, i.e. the eighth week after start of intervention.

  4. Parkinson's Disease Questionnaire (PDQ-39)

    The PDQ-39 is a 39-item self-report questionnaire designed to assess health-related quality of life in people with Parkinson's disease. It covers 8 domains: mobility, activities of daily living, emotional well-being, stigma, social support, cognitions, communication, and sleep.

    Measured: Evaluations will be conducted at the time of randomization and will serve as baseline data.

  5. Parkinson's Disease Questionnaire (PDQ-39)

    The PDQ-39 is a 39-item self-report questionnaire designed to assess health-related quality of life in people with Parkinson's disease. It covers 8 domains: mobility, activities of daily living, emotional well-being, stigma, social support, cognitions, communication, and sleep.

    Measured: Evaluations will be conducted at the fourth week after the start of the intervention.

  6. Parkinson's Disease Questionnaire (PDQ-39)

    The PDQ-39 is a 39-item self-report questionnaire designed to assess health-related quality of life in people with Parkinson's disease. It covers 8 domains: mobility, activities of daily living, emotional well-being, stigma, social support, cognitions, communication, and sleep.

    Measured: Evaluations will be conducted at the fourth week after the end of the intervention, i.e. the eighth week after start of intervention.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2025
  2. Study start15 Dec 2025 (estimated)
  3. Primary completion31 Jul 2027 (estimated)
  4. Study completion31 Jul 2027 (estimated)

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07294469
Sponsor's protocol ID
N202505079
Status last verified
Oct 2025
First submitted
8 Dec 2025
Last updated
8 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Data including paper and electronic files will be destroyed after two years since the end of the study. Data obtained from the study, if digitized, will be stored on the investigator's computer in the hospital office and secured the password. Written data will be kept in a locked drawer in the investigator's office and stored separately from the subject's consent form. The data will be kept for five years after the end of the trial, at which time the digital data will be deleted from the computer and the written data will be deleted by shredder.

Publications

  • Huang SS, Su HH, Chien SY, Chung HY, Luo ST, Chu YT, Wang YH, MacDonald IJ, Lee HH, Chen YH. Activation of peripheral TRPM8 mitigates ischemic stroke by topically applied menthol. J Neuroinflammation. 2022 Jul 27;19(1):192. doi: 10.1186/s12974-022-02553-4.

    PubMed 35897101

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Menthol gloves and socks in people with Parkinson's Disease, run by Taipei Medical University Hospital at 1 site in Taiwan.

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 6 inclusion and 5 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: opening soon, as of the sponsor's last update on 8 Jan 2026. 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 Taiwan. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Hsun-Hua Lee, MD-PhD ((886)02-27372181, kaorulei@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Unified Parkinson's Disease Rating Scale (UPDRS) I,II,III (time frame: Evaluations will be conducted at the time of randomization and will serve as baseline data.). The study lists 6 primary outcomes in all. 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 NCT07294469, 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 8 Jan 2026.

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