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

NCT06432309 | Completed DMC

• 1 other identifier: 480/2022/Oss/AOUFe
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Parkinson Disease; Effect of Drug

Outcome Measures

Primary Outcomes (2)

• Evaluation of motor fluctuations changes

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

  12 months

• Evaluation of dyskinesia changes

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

  12 months

Secondary Outcomes (4)

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

  12 months

• Changes in motor aspects of patients' daily living experiences

  12 months

• Changes in non-motor symptoms in Parkinson's disease-cognition

  12 months

• Neurophysiological outcome

  12 months

Study Arms (2)

nOPC: Duodopa (Levodopa/carbidopa intestinal gel) in monotherapy

OTHER

Levodopa carbidopa intestinal gel infusion. Diurnal infusion from 7.a.m to 11 p.m.

Drug: Duodopa

add-OPC: Duodopa plus OPC therapy

ACTIVE COMPARATOR

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: Opicapone 50 mg; Drug: Duodopa

Interventions

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.

Also known as: OPC

add-OPC: Duodopa plus OPC therapy

Duodopa DRUG

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

Also known as: Levodopa/carbidopa intestinal gel (LCIG)

add-OPC: Duodopa plus OPC therapy; nOPC: Duodopa (Levodopa/carbidopa intestinal gel) in monotherapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 ).

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital of Ferrara: lead

Study Sites (1)

University Hospital of Ferrara - Arcispedale Sant'Anna

Ferrara, Emilia-Romagna, 44122, Italy

Location

Related Publications (4)

• 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.

  PMID: 35785401 BACKGROUND

• 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.

  PMID: 30264443 BACKGROUND

• 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.

  PMID: 38287715 BACKGROUND

• 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.

  PMID: 32597817 RESULT

MeSH Terms

Conditions

Parkinson Disease

Interventions

opicapone; carbidopa, levodopa drug combination; Levodopa

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Dihydroxyphenylalanine; Catecholamines; Amines; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Tyrosine

Study Officials

• Mariachiara Sensi, MD-Phd

  Azienda Ospedaliero -Universitaria S. Anna Ferrara

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective randomised blinded End-point study

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: May 29, 2024
• Study Start: July 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: April 25, 2024
• Last Updated: March 3, 2025

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)