PARKINSON DISEASE (Disorder)OPITECHNCT07917546
Early COMT Inhibition in PD
A study testing Opicapone 50 mg and L-DOPA/DDCI in people with PARKINSON DISEASE (Disorder), run by Neuromed IRCCS at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- PARKINSON DISEASE (Disorder)
- What is being tested?
- Opicapone 50 mg and L-DOPA/DDCI
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2024to 31 Dec 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Dementia, defined as a Mini-Mental State Examination (MMSE) score below 24.
- Diagnosis of atypical parkinsonism.
- Inability to walk independently.
- Known intolerance to catechol-O-methyltransferase (COMT) inhibitors.
- Previous treatment with COMT inhibitors.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early COMT Inhibition in Parkinson's Disease: A Randomized Single-Blind Study With Digital Biomarkers
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).
Read more
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.
Read the detailed description
Motor fluctuations represent a major complication of Parkinson's disease (PD) and may emerge during the early stages of levodopa treatment. These fluctuations commonly manifest as wearing-off episodes, characterized by the reappearance of motor symptoms before the next scheduled levodopa dose. Conventional therapeutic approaches include increasing or fractionating levodopa doses or introducing adjunctive treatments aimed at prolonging levodopa availability.
Catechol-O-methyltransferase (COMT) inhibitors, such as opicapone, may improve the stability of dopaminergic stimulation by increasing levodopa bioavailability and prolonging its therapeutic effect. However, the comparative effectiveness of early COMT inhibition and levodopa dose escalation on motor fluctuations and everyday motor performance remains incompletely established. In addition, conventional clinical scales may not adequately capture the temporal variability of motor symptoms during daily activities.
This prospective, randomized, assessor-blinded, parallel-group study was designed to compare early add-on opicapone with levodopa dose escalation in patients with PD experiencing emerging motor fluctuations. The study also investigates the usefulness of wearable-derived digital biomarkers for objectively quantifying treatment-related changes in real-world motor performance.
Forty-six patients with idiopathic PD and emerging wearing-off symptoms were enrolled at the Movement Disorders outpatient clinic of Sapienza University of Rome, Italy. Participants were randomized in a 1:1 ratio using computer-generated allocation to one of two treatment strategies:
Opicapone group: Opicapone 50 mg once daily added to the existing dopaminergic treatment.
Levodopa escalation group: An additional 100-200 mg/day of levodopa combined with a dopa-decarboxylase inhibitor, administered as an additional dose or distributed across existing daily administrations.
Treatment adjustments were permitted during the initial two weeks according to clinical response and tolerability. Clinical assessments were performed by a movement disorders specialist blinded to treatment allocation.
Participants underwent standardized neurological and clinical evaluations at baseline and after approximately four weeks of treatment. Assessments included motor symptom severity, motor fluctuations, global clinical improvement, patient-perceived treatment response, and health-related quality of life.
Objective motor monitoring was performed using the STAT-ON wearable sensor (Sense4Care, Barcelona, Spain), positioned at the waist. Participants wore the device during their usual daily activities for seven consecutive days at baseline and again after treatment. The device uses accelerometry and validated signal-processing algorithms to estimate medication-related motor states and quantify spatiotemporal gait characteristics, including step length, gait velocity, cadence, and their variability.
The primary objective was to compare the change in wearable-derived daily OFF time between treatment groups from baseline to the four-week follow-up. Secondary objectives included evaluating changes in gait performance and variability, clinical motor severity, wearing-off symptoms, patient-reported improvement, quality of life, and treatment tolerability.
Safety assessments included neurological and physical examinations, vital signs, concomitant medication review, and monitoring of treatment-emergent adverse events.
The study was designed to investigate whether early COMT inhibition offers advantages over levodopa dose escalation in controlling emerging motor fluctuations and improving motor stability during everyday activities. Furthermore, it aims to explore the complementary role of wearable-derived digital biomarkers alongside conventional clinical and patient-reported assessments in evaluating therapeutic response in Parkinson's disease.
- Conditions
- PARKINSON DISEASE (Disorder)
- Being tested
- Opicapone 50 mg, L-DOPA/DDCI
- Keywords
- motor fluctuations, parkinson's disease, wearable sensors
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opicapone 50 mgDrug
Opicapone 50 mg administered orally once daily as adjunctive therapy to the existing levodopa/dopa-decarboxylase inhibitor (DDCI) regimen for approximately four weeks. Adjustments to levodopa dosage a
L-DOPA/DDCIDrug
An additional 100-200 mg/day of levodopa combined with a dopa-decarboxylase inhibitor (DDCI), administered orally for approximately four weeks. The additional dose was either introduced as a separate daily administration or distributed across existing doses, according to the patient's treatment schedule and clinical needs. Patients receiving three daily doses could increase to four administrations, while those already receiving four daily doses could receive an increased dose within their existing schedule.
| Study group | Role | What they receive |
|---|---|---|
| Opicapone subgroup | Experimental | Participants randomized to this arm received opicapone 50 mg orally once daily as add-on therapy to their existing levodopa/dopa-decarboxylase inhibitor (DDCI) regimen for approximately four weeks. Adjustments to levodopa dosage and administration schedule were permitted during the first two weeks based on clinical response and tolerability. Treatment efficacy was evaluated through standardized clinical assessments and seven-day home-based wearable sensor monitoring at baseline and follow-up. Receives: Drug: Opicapone 50 mg |
| "L-Dopa escalation" subgroup | Active comparator | Participants randomized to this arm received an additional 100-200 mg/day of levodopa combined with a dopa-decarboxylase inhibitor (DDCI) for approximately four weeks. The additional levodopa dose was administered either as an extra daily dose or distributed across existing administrations, according to the patient's treatment schedule and clinical needs. Treatment efficacy was evaluated through standardized clinical assessments and seven-day home-based wearable sensor monitoring at baseline and follow-up. Receives: Drug: L-DOPA/DDCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Wearable-Derived Daily OFF Time
Percentage change in daily time spent in the OFF motor state from baseline to the four-week follow-up, objectively assessed using the STAT-ON wearable sensor during seven consecutive days of home-based monitoring. The device automatically classifies motor states using accelerometry-based algorithms. OFF time is expressed as a percentage of daily monitored time. The outcome is calculated as the difference between follow-up and baseline OFF time percentages, with negative values indicating a reduction in OFF time and clinical improvement.
Measured: Baseline and Week 4 (7 consecutive days of wearable monitoring at each time point)
Secondary outcomes (6)
Change in Step Length Variability
Change from baseline to Week 4 in the coefficient of variation of step length (%), measured using wearable sensors during daily-life monitoring. Lower values indicate more consistent gait performance.
Measured: Baseline and Week 4 (7 consecutive days of wearable monitoring at each time point)
Change in Gait Velocity Variability
Change from baseline to Week 4 in the coefficient of variation of gait velocity (%), measured using wearable sensors during daily-life monitoring. Lower values indicate more consistent gait performance.
Measured: Baseline and Week 4 (7 consecutive days of wearable monitoring at each time point)
3. Change in MDS-UPDRS Part III Score
Change from baseline to Week 4 in motor symptom severity assessed using Part III of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale. Scores range from 0 to 132, with higher scores indicating greater motor impairment.
Measured: Baseline and Week 4
Change in WOQ-19 Score
Change from baseline to Week 4 in wearing-off symptoms assessed using the 19-item Wearing-Off Questionnaire. Scores range from 0 to 19, with higher scores indicating more wearing-off symptoms.
Measured: Baseline and Week 4
Change in PDQ-8 Score
Change from baseline to Week 4 in health-related quality of life assessed using the 8-item Parkinson's Disease Questionnaire. The Summary Index ranges from 0 to 100, with higher scores indicating poorer quality of life.
Measured: Baseline and Week 4
Patient Global Impression of Change (PGI-C)
Patient-reported global change in clinical condition at Week 4 compared with baseline, assessed using the Patient Global Impression of Change scale. Scores range from 1 (very much improved) to 7 (very much worse), with higher scores indicating a worse outcome.
Measured: Baseline and Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start1 Jan 2024
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PARKINSON DISEASE (Disorder)Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neuromed IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Suppa, Neuromed IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07917546
- Sponsor's protocol ID
- Prot. 0372/2022
- Acronym
- OPITECH
- Status last verified
- Oct 2026
- First submitted
- 20 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be made publicly available due to patient confidentiality and data protection considerations. Aggregated and anonymized study results will be reported in scientific publications.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early COMT Inhibition in Parkinson's Disease: A Randomized Single-Blind Study With Digital Biomarkers
- ClinicalTrials.gov ID
- NCT07917546
- Acronym / sponsor ID
- OPITECH / Prot. 0372/2022
- Conditions
- PARKINSON DISEASE (Disorder)
- Keywords
- motor fluctuations, parkinson's disease, wearable sensors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Neuromed IRCCSUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 4 Nov 2026 (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 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.
Detailed description
Motor fluctuations represent a major complication of Parkinson's disease (PD) and may emerge during the early stages of levodopa treatment. These fluctuations commonly manifest as wearing-off episodes, characterized by the reappearance of motor symptoms before the next scheduled levodopa dose. Conventional therapeutic approaches include increasing or fractionating levodopa doses or introducing adjunctive treatments aimed at prolonging levodopa availability.
Catechol-O-methyltransferase (COMT) inhibitors, such as opicapone, may improve the stability of dopaminergic stimulation by increasing levodopa bioavailability and prolonging its therapeutic effect. However, the comparative effectiveness of early COMT inhibition and levodopa dose escalation on motor fluctuations and everyday motor performance remains incompletely established. In addition, conventional clinical scales may not adequately capture the temporal variability of motor symptoms during daily activities.
This prospective, randomized, assessor-blinded, parallel-group study was designed to compare early add-on opicapone with levodopa dose escalation in patients with PD experiencing emerging motor fluctuations. The study also investigates the usefulness of wearable-derived digital biomarkers for objectively quantifying treatment-related changes in real-world motor performance.
Forty-six patients with idiopathic PD and emerging wearing-off symptoms were enrolled at the Movement Disorders outpatient clinic of Sapienza University of Rome, Italy. Participants were randomized in a 1:1 ratio using computer-generated allocation to one of two treatment strategies:
Opicapone group: Opicapone 50 mg once daily added to the existing dopaminergic treatment.
Levodopa escalation group: An additional 100-200 mg/day of levodopa combined with a dopa-decarboxylase inhibitor, administered as an additional dose or distributed across existing daily administrations.
Treatment adjustments were permitted during the initial two weeks according to clinical response and tolerability. Clinical assessments were performed by a movement disorders specialist blinded to treatment allocation.
Participants underwent standardized neurological and clinical evaluations at baseline and after approximately four weeks of treatment. Assessments included motor symptom severity, motor fluctuations, global clinical improvement, patient-perceived treatment response, and health-related quality of life.
Objective motor monitoring was performed using the STAT-ON wearable sensor (Sense4Care, Barcelona, Spain), positioned at the waist. Participants wore the device during their usual daily activities for seven consecutive days at baseline and again after treatment. The device uses accelerometry and validated signal-processing algorithms to estimate medication-related motor states and quantify spatiotemporal gait characteristics, including step length, gait velocity, cadence, and their variability.
The primary objective was to compare the change in wearable-derived daily OFF time between treatment groups from baseline to the four-week follow-up. Secondary objectives included evaluating changes in gait performance and variability, clinical motor severity, wearing-off symptoms, patient-reported improvement, quality of life, and treatment tolerability.
Safety assessments included neurological and physical examinations, vital signs, concomitant medication review, and monitoring of treatment-emergent adverse events.
The study was designed to investigate whether early COMT inhibition offers advantages over levodopa dose escalation in controlling emerging motor fluctuations and improving motor stability during everyday activities. Furthermore, it aims to explore the complementary role of wearable-derived digital biomarkers alongside conventional clinical and patient-reported assessments in evaluating therapeutic response in Parkinson's disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Opicapone subgroup | Experimental | Drug: Opicapone 50 mgParticipants randomized to this arm received opicapone 50 mg orally once daily as add-on therapy to their existing levodopa/dopa-decarboxylase inhibitor (DDCI) regimen for approximately four weeks. Adjustments to levodopa dosage and administration schedule were permitted during the first two weeks based on clinical response and tolerability. Treatment efficacy was evaluated through standardized clinical assessments and seven-day home-based wearable sensor monitoring at baseline and follow-up. |
| "L-Dopa escalation" subgroup | Active comparator | Drug: L-DOPA/DDCIParticipants randomized to this arm received an additional 100-200 mg/day of levodopa combined with a dopa-decarboxylase inhibitor (DDCI) for approximately four weeks. The additional levodopa dose was administered either as an extra daily dose or distributed across existing administrations, according to the patient's treatment schedule and clinical needs. Treatment efficacy was evaluated through standardized clinical assessments and seven-day home-based wearable sensor monitoring at baseline and follow-up. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- Dementia, defined as a Mini-Mental State Examination (MMSE) score below 24.
- Diagnosis of atypical parkinsonism.
- Inability to walk independently.
- Known intolerance to catechol-O-methyltransferase (COMT) inhibitors.
- Previous treatment with COMT inhibitors.
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 |
|---|---|---|
| Opicapone 50 mgOpicapone 50 mg administered orally once daily as adjunctive therapy to the existing levodopa/dopa-decarboxylase inhibitor (DDCI) regimen for approximately four weeks. Adjustments to levodopa dosage a | Drug | Opicapone subgroup |
| L-DOPA/DDCIAn additional 100-200 mg/day of levodopa combined with a dopa-decarboxylase inhibitor (DDCI), administered orally for approximately four weeks. The additional dose was either introduced as a separate daily administration or distributed across existing doses, according to the patient's treatment schedule and clinical needs. Patients receiving three daily doses could increase to four administrations, while those already receiving four daily doses could receive an increased dose within their existing schedule. | Drug | "L-Dopa escalation" subgroup |
Primary outcome
Change in Wearable-Derived Daily OFF Time
Time frame: Baseline and Week 4 (7 consecutive days of wearable monitoring at each time point)
Percentage change in daily time spent in the OFF motor state from baseline to the four-week follow-up, objectively assessed using the STAT-ON wearable sensor during seven consecutive days of home-based monitoring. The device automatically classifies motor states using accelerometry-based algorithms. OFF time is expressed as a percentage of daily monitored time. The outcome is calculated as the difference between follow-up and baseline OFF time percentages, with negative values indicating a reduction in OFF time and clinical improvement.
6 secondary outcomes
Change in Step Length Variability
Time frame: Baseline and Week 4 (7 consecutive days of wearable monitoring at each time point)
Change in Gait Velocity Variability
Time frame: Baseline and Week 4 (7 consecutive days of wearable monitoring at each time point)
3. Change in MDS-UPDRS Part III Score
Time frame: Baseline and Week 4
Change in WOQ-19 Score
Time frame: Baseline and Week 4
Change in PDQ-8 Score
Time frame: Baseline and Week 4
Patient Global Impression of Change (PGI-C)
Time frame: Baseline and Week 4
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 4 Nov 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be made publicly available due to patient confidentiality and data protection considerations. Aggregated and anonymized study results will be reported in scientific publications.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Opicapone 50 mg and L-DOPA/DDCI in people with PARKINSON DISEASE (Disorder), run by Neuromed IRCCS at 1 site in Italy.
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 5 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: finished, as of the sponsor's last update on 4 Nov 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 Italy. 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. 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 Wearable-Derived Daily OFF Time (time frame: Baseline and Week 4 (7 consecutive days of wearable monitoring at each time point)). 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 4 Nov 2026; AzTrials last refreshed its copy on 5 Nov 2026.