Menthol for Improving Movement and Sleep in Parkinson's Disease Patients (NCT07294469) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Menthol for Improving Movement and Sleep in Parkinson's Disease Patients
Taiwan80 participantsStarted 2025-12-15
Plain-language 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. 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.
Who can participate
Age range30 Years – 80 Years
SexALL
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Inclusion criteria
✓. 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.
✕. 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.