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OPTIMO

Real-world data of opicapone in patients with Parkinson's disease experiencing motor fluctuations: the OPTIMO study

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Year of Publication: 2026

Authors: María‑Rosario Luquin, Nuria Lopez-Ariztegui, Juan Carlos Martínez Castrillo, ..., Iciar Tegel Ayuela

Journal: Frontiers in Neurology

Citation: Front. Neurol., Volume 17, 19 February 2026

Link: https://doi.org/10.3389/fneur.2026.1738500

Clinical Question

What are the effectiveness and tolerability outcomes of opicapone as add-on treatment to levodopa/DDCI in patients with Parkinson's disease and motor fluctuations in real-world clinical practice in Spain?

Bottom Line

In real-world clinical practice, opicapone added to levodopa significantly improves motor function and reduces motor fluctuations without significantly enhancing dyskinesia intensity, with a tolerable safety profile across different PD phenotypes.

Major Points

  • 74.2% of patients reported clinical improvement in motor fluctuations, with 64.6% showing improvement without worsening dyskinesias
  • Daily off-time significantly decreased from 143.3 to 67.9 minutes (p<0.001)
  • Wearing-off phenomena reduced from 98.0% to 61.6% of patients
  • UPDRS Parts II-IV scores significantly improved after mean 4.8 months of treatment
  • Clinical benefit was similar across different PD phenotypes (akinetic-rigid, tremor-dominant, mixed)
  • Only 8.3% of patients experienced mild treatment-related adverse events
  • Lower baseline daily off-time and minimal dyskinesias predicted better clinical response

Design

Study Type: Multicenter, observational, retrospective, post-authorization study

Randomization:

Blinding: None (open-label observational)

Enrollment Period: August 2019 to May 2021 (12-month recruitment period)

Follow-up Duration: 3 to 7 months (mean 4.8 months)

Centers: 16

Countries: Spain

Sample Size: 245

Analysis: Descriptive statistics, Fisher's exact test, Wilcoxon-Mann-Whitney test, McNemar test, logistic regression for predictive factors; significance at p<0.05

Inclusion Criteria

  • Adults ≥18 years old
  • Diagnosed with Parkinson's disease
  • Hoehn & Yahr stage I-III during ON periods
  • Levodopa-induced motor complications (motor fluctuations with or without dyskinesia)
  • Receiving opicapone for at least 3 months prior to study enrollment
  • Treatment with levodopa + DDCI

Exclusion Criteria

  • Non-compliance with eligibility criteria (18 patients excluded for this reason)

Arms

FieldOpicapone add-on therapy
InterventionOpicapone 50 mg/day added to levodopa/DDCI
DurationMean 4.8 (3.6) months (range 3-7 months)

Outcomes

OutcomeTypeControlInterventionHR / OR / RRP-value
Percentage of patients reporting motor fluctuation improvement without worsening dyskinesias according to PGI-C scalePrimary64.6% (95% CI: 57.1-71.6%)
Overall improvement in motor fluctuations (PGI-C)Secondary74.2% (95% CI: 67.1-80.4%)
Mean daily off-time (minutes)Secondary143.3 (126.4)67.9 (111.2)<0.001
Wearing-off motor fluctuationsSecondary98.0%61.6%
Delayed-on motor fluctuationsSecondary10.2%5.3%0.010
No-on motor fluctuationsSecondary6.5%2.9%0.027
Non-motor fluctuationsSecondary21.6%15.1%0.010
Morning akinesiaSecondary35.9%24.1%<0.001
Nocturnal akinesiaSecondary20.8%8.2%<0.001
Impulse control disordersSecondary6.1%2.4%0.016
UPDRS Part II change (activities of daily living)Secondary10.1 (6.4)8.2 (5.4)<0.001
UPDRS Part III change (motor function)Secondary22.4 (9.5)19.0 (10.7)<0.001
UPDRS I-III total scoreSecondary34.7 (13.6)28.3 (14.8)<0.001
UPDRS Part IV (motor complications)Secondary6.7 (3.8)4.5 (3.3)<0.001
12.2% (30 patients)Adverse
8.6% (21 patients)Adverse
3.7% (9 patients)Adverse
0.8% (2 patients)Adverse
0.8% (2 patients)Adverse
0.8% (2 patients)Adverse
0.8% (2 patients)Adverse
0.8% (2 patients)Adverse
0.8% (2 patients)Adverse
0.4% (1 patient - hallucinations)Adverse

Subgroup Analysis

Clinical improvement in motor fluctuations with stable/improved dyskinesias was similar across PD phenotypes (akinetic-rigid, tremor-dominant, mixed; p=0.327). Predictive factors for clinical improvement: lower daily off-time before opicapone, minimal time with dyskinesias, and minimal complexity of motor fluctuations.

Criticisms

  • Retrospective observational design limits causal inference
  • No control group for direct comparison
  • PGI-C data available for only 73% of patients (178/245)
  • Variable follow-up duration (3-7 months)
  • Missing data not imputed, which may introduce bias
  • Relatively short follow-up period (mean 4.8 months)
  • Data dependent on quality of medical record documentation
  • Single country (Spain) limits generalizability
  • Calculated sample size (432) not achieved (245 enrolled)
  • Potential selection bias in consecutive patient enrollment

Funding

Medical Department, Laboratorios Bial S.A, Madrid, Spain (manufacturer of opicapone)

Based on: OPTIMO (Frontiers in Neurology, 2026)

Authors: María‑Rosario Luquin, Nuria Lopez-Ariztegui, Juan Carlos Martínez Castrillo, ..., Iciar Tegel Ayuela

Citation: Front. Neurol., Volume 17, 19 February 2026

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