An interventional study of Opicapone 50 mg and L-DOPA/DDCI in PARKINSON DISEASE (Disorder), sponsored by Neuromed IRCCS. Completed at 1 site in Italy. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Neuromed IRCCS · Not applicable, Interventional, and Treatment
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.
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.
4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.
This study's enrollment of 46 is above the median of 40 across 3,353 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Neuromed IRCCS is the lead sponsor of 81 studies on the registry; 25 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Opicapone 50 mg
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.
Drug: L-DOPA/DDCI
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
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.
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.
Time frame: Baseline and Week 4 (7 consecutive days of wearable monitoring at each time point)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and Week 4
Plan to share: 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.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Opicapone
Neuromed IRCCS