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NCT Number: NCT06432309

Opicapone as Adjunctive Therapy to Levodopa-Carbidopa Intestinal Gel in Parkinson's Disease

Levodopa-Carbidopa intestinal gel (LCIG) is an effective therapy for complicated Parkinson's disease (PD). Few studies have explored the efficacy and safety of the potential combination of LCIG with catechol-O-methyltransferase (COMT) inhibitors, particularly Opicapone (OPC).

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Effect of Drug Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Ferrara - Arcispedale Sant'Anna

Ferrara, Emilia-Romagna, 44122, Italy

About this study

22 PD patients were randomized into LCIG monotherapy (n-OPC 11 patients) and LCIG+OPC (add-OPC 11 patients), further divided according to OPC adding time (E-OPC within one month and L-OPC after one month from LCIG implant).

Data on PD clinical aspects, Montreal Cognitive Assessment (MoCA), Unified Parkinson's Disease Rating Scale (UPDRS), Unified Dyskinesia Rating Scale (UDysRS), electroneurography (ENG), and pharmacological therapy (Levodopa Equivalent Dose-LEDD) were collected before LCIG implanted (T0) and in the following 12 (T1) months.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • LCIG implantation not longer than 30 months before the study enrollment,
  • Presence of nocturnal akinesia (assessed by medical history and through item 2.9 of MDS-UPDRS part II (> 2), or/and
  • Persistence of morning or afternoon akinesia (assessed by item 4.3 in MDS UPDRS -IV( >2 ).

Exclusion criteria

  • Hoehn & Yahr (H&Y) >4,
  • Cognitive decline (MOCA< 17),
  • more than 30 months after LCIG positioning,
  • not compliant with treatment and follow-up visits.

Treatment and study plan

Opicapone 50 mg

Drug

Evaluate the addition of the COMT-I, Opicapone, to the Levodopa-Carbidopa intestinal gel in Parkinson's Disease patients with motor fluctuations.

Other names: OPC

Duodopa

Drug

Evaluate Levodopa-Carbidopa intestinal gel in Parkinson's Disease patients with motor fluctuations.

Other names: Levodopa/carbidopa intestinal gel (LCIG)

Primary outcomes

  1. Evaluation of motor fluctuations changes

    Time frame: 12 months

    Changes in MDS-UPDRS part IV from the initial assessment to 12 months follow-up.

  2. Evaluation of dyskinesia changes

    Time frame: 12 months

    Changes in UDysRS from the initial assessment to 12 months follow-up.

Secondary outcomes

  1. Changes in non-motor aspects of patients' daily living experiences

    Time frame: 12 months

    Changes of MDS-UPDRS I score from the initial assessment to 12 months follow-up.

  2. Changes in motor aspects of patients' daily living experiences

    Time frame: 12 months

    Changes of of MDS-UPDRS II score from the initial assessment to 12 months follow-up.

  3. Changes in non-motor symptoms in Parkinson's disease-cognition

    Time frame: 12 months

    Changes of MOCA score from the initial assessment to 12 months follow-up.

  4. Neurophysiological outcome

    Time frame: 12 months

    Changes of sural amplitude potential through electroneurography from the initial assessment to 12 months follow-up.

Sponsors and collaborators

Lead sponsor

University Hospital of Ferrara

Other

Registry information

Official study title

Efficacy and Safety of Opicapone in Parkinson's Disease Add -on to Levodopa Carbidopa Intestinal Gel

Acronym: OPAILEC

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
May 29, 2024
Registry last updated
Mar 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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