AzTrials
AzTrials

Parkinson DiseaseOPAILECNCT06432309

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

A study testing Opicapone 50 mg and Duodopa in people with Parkinson Disease and Effect of Drug, run by University Hospital of Ferrara at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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). Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Parkinson Disease, Effect of Drug
What is being tested?
Opicapone 50 mg and Duodopa
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteItaly
Study dates
1 Jul 2022to 25 Apr 2024
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 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 ).

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • University Hospital of Ferrara - Arcispedale Sant'Anna

    Ferrara, Emilia-Romagna, 44122

Other trials in Italy

About this study

Official title: 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).

Read the 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.

Being tested
Opicapone 50 mg, Duodopa
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

    Also called OPC

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

  • DuodopaDrug

    Also called Levodopa/carbidopa intestinal gel (LCIG)

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

Study groups in NCT06432309
Study groupRoleWhat they receive
nOPC: Duodopa (Levodopa/carbidopa intestinal gel) in monotherapyOtherLevodopa carbidopa intestinal gel infusion. Diurnal infusion from 7.a.m to 11 p.m.
Receives: Drug: Duodopa
add-OPC: Duodopa plus OPC therapyActive comparatorLevodopa 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)
Receives: Drug: Opicapone 50 mg; Drug: Duodopa

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluation of motor fluctuations changes

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

    Measured: 12 months

  2. Evaluation of dyskinesia changes

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

    Measured: 12 months

Secondary outcomes (4)

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

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

    Measured: 12 months

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

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

    Measured: 12 months

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

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

    Measured: 12 months

  4. Neurophysiological outcome

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

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 May 2024
  2. Study start1 Jul 2022
  3. Primary completion31 Dec 2023
  4. Study completion25 Apr 2024

Resources

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
Model description
Prospective randomised blinded End-point study
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06432309
Sponsor's protocol ID
480/2022/Oss/AOUFe
Acronym
OPAILEC
Status last verified
Oct 2022
First submitted
7 May 2024
Last updated
3 Mar 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Nyholm D, Jost WH. Levodopa-entacapone-carbidopa intestinal gel infusion in advanced Parkinson's disease: real-world experience and practical guidance. Ther Adv Neurol Disord. 2022 Jun 26;15:17562864221108018. doi: 10.1177/17562864221108018. eCollection 2022.

    PubMed 35785401

  • Fabbri M, Ferreira JJ, Lees A, Stocchi F, Poewe W, Tolosa E, Rascol O. Opicapone for the treatment of Parkinson's disease: A review of a new licensed medicine. Mov Disord. 2018 Oct;33(10):1528-1539. doi: 10.1002/mds.27475. Epub 2018 Sep 27.

    PubMed 30264443

  • Ikenaka K, Kajiyama Y, Aguirre C, Choong CJ, Taniguchi S, Doi J, Wang N, Ajiki T, Ogawa K, Kakuda K, Kimura Y, Mochizuki H. Decreased hepatic enzymes reflect the decreased vitamin B6 levels in Parkinson's disease patients. Pharmacol Res Perspect. 2024 Feb;12(1):e1174. doi: 10.1002/prp2.1174.

    PubMed 38287715

  • Leta V, van Wamelen DJ, Sauerbier A, Jones S, Parry M, Rizos A, Chaudhuri KR. Opicapone and Levodopa-Carbidopa Intestinal Gel Infusion: The Way Forward Towards Cost Savings for Healthcare Systems? J Parkinsons Dis. 2020;10(4):1535-1539. doi: 10.3233/JPD-202022.

    PubMed 32597817

Questions about this trial

What is this clinical trial studying?

A study testing Opicapone 50 mg and Duodopa in people with Parkinson Disease and Effect of Drug, run by University Hospital of Ferrara 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 3 inclusion and 4 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 3 Mar 2025. 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?

Evaluation of motor fluctuations changes (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06432309, which also lists 4 linked publications.

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 3 Mar 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in