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

Parkinson Disease Clinical Trial

— OPAILEC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06432309
• Other study ID #: 480/2022/Oss/AOUFe
• Status: Completed
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: April 25, 2024

Study information

• Verified date: July 2022
• Source: University Hospital of Ferrara
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: April 25, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Effect of Drug
• Parkinson Disease

Intervention

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

Locations

Country	Name	City	State
Italy	University Hospital of Ferrara - Arcispedale Sant'Anna	Ferrara	Emilia Romagna

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of Ferrara

Country where clinical trial is conducted

Italy, 

References & Publications (4)

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. — View Citation

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. — View Citation

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-2 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of motor fluctuations changes	Changes in MDS-UPDRS part IV from the initial assessment to 12 months follow-up.	12 months
Primary	Evaluation of dyskinesia changes	Changes in UDysRS from the initial assessment to 12 months follow-up.	12 months
Secondary	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.	12 months
Secondary	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.	12 months
Secondary	Changes in non-motor symptoms in Parkinson's disease-cognition	Changes of MOCA score from the initial assessment to 12 months follow-up.	12 months
Secondary	Neurophysiological outcome	Changes of sural amplitude potential through electroneurography from the initial assessment to 12 months follow-up.	12 months