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

February 26, 2025 updated by: University Hospital of Ferrara

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Emilia Romagna
      • Ferrara, Emilia Romagna, Italy, 44122
        • University Hospital of Ferrara - Arcispedale Sant'Anna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: nOPC: Duodopa (Levodopa/carbidopa intestinal gel) in monotherapy
Levodopa carbidopa intestinal gel infusion. Diurnal infusion from 7.a.m to 11 p.m.
Drug: Duodopa
Evaluate Levodopa-Carbidopa intestinal gel in Parkinson's Disease patients with motor fluctuations.
Other Names:
  • Levodopa/carbidopa intestinal gel (LCIG)
Active Comparator: add-OPC: Duodopa plus OPC therapy
Levodopa carbidopa intestinal gel infusion (Diurnal infusion from 7 a.m to 11 p.m) plus Opicapone 50 mg 1 tablet at nighttime (11 p.m)
Drug: Duodopa
Evaluate Levodopa-Carbidopa intestinal gel in Parkinson's Disease patients with motor fluctuations.
Other Names:
  • Levodopa/carbidopa intestinal gel (LCIG)
Drug: Opicapone 50 mg
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of motor fluctuations changes
Time Frame: 12 months
Changes in MDS-UPDRS part IV from the initial assessment to 12 months follow-up.
12 months
Evaluation of dyskinesia changes
Time Frame: 12 months
Changes in UDysRS from the initial assessment to 12 months follow-up.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months
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.
12 months
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.
12 months
Neurophysiological outcome
Time Frame: 12 months
Changes of sural amplitude potential through electroneurography from the initial assessment to 12 months follow-up.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital of Ferrara

Investigators

  • Principal Investigator: Mariachiara Sensi, MD-Phd, Azienda Ospedaliero -Universitaria S. Anna Ferrara

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2022

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

April 25, 2024

Study Registration Dates

First Submitted

May 7, 2024

First Submitted That Met QC Criteria

May 28, 2024

First Posted (Actual)

May 29, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 26, 2025

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 480/2022/Oss/AOUFe

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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