NCT07917546Completed
Early COMT Inhibition in PD
Early COMT Inhibition in Parkinson's Disease: A Randomized Single-Blind Study With Digital Biomarkers
Source: ClinicalTrials.gov · Last updated 4 Nov 2026
Brief summary (registry, in English)
This prospective, randomized, assessor-blinded, parallel-group clinical trial aims to compare the effectiveness of early add-on opicapone versus levodopa dose escalation in patients with Parkinson's disease experiencing emerging motor fluctuations. A total of 46 patients are randomly assigned (1:1) to receive either opicapone 50 mg once daily in addition to their existing dopaminergic treatment or an additional daily dose of levodopa/dopa-decarboxylase inhibitor (100-200 mg). Treatment effects are assessed over approximately four weeks through standardized clinical evaluations, patient-reported outcome measures, and continuous home-based monitoring using wearable sensors. The primary outcome is the change in daily OFF time objectively estimated by wearable technology. Secondary outcomes include gait performance and variability, motor symptom severity, patient-perceived improvement, quality of life, and treatment safety. The study aims to determine whether early COMT inhibition provides greater control of motor fluctuations than levodopa dose escalation and to investigate the utility of wearable-derived digital biomarkers for evaluating treatment response under real-world conditions.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 46 (actual)
- First submitted
- 20 Oct 2026
- Start date
- 1 Jan 2024
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Neuromed IRCCS
- Diseases
- Parkinson disease
- NCT number
- NCT07917546
What you commit to
- Study type: Interventional
- Participants enrolled: 46
- From 1 Jan 2024 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Known intolerance to catechol-O-methyltransferase (COMT) inhibitors.
- Previous treatment with COMT inhibitors.
Other illness
- Dementia, defined as a Mini-Mental State Examination (MMSE) score below 24.
Other
- Diagnosis of atypical parkinsonism.
- Inability to walk independently.
Who the study is looking for
- Diagnosis of idiopathic Parkinson's disease according to established clinical diagnostic criteria.
- Presence of wearing-off motor fluctuations, including early morning akinesia, with at least 1 hour of daily awake OFF time persisting for a period ranging from 4 weeks to 2 years.
- Stable treatment with levodopa/dopa-decarboxylase inhibitor (DDCI), administered 3-4 times daily, for at least 30 days before enrollment.
- Concomitant treatment with dopamine agonists or monoamine oxidase-B inhibitors permitted.
- Levodopa equivalent daily dose (LEDD) ≥300 mg.
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sapienza University of Rome Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.