Clinical trial NCT06432309: Opicapone as Adjunctive Therapy to Levodopa-Carbidopa Intestinal Gel in Parkinson's Disease
Official title: Efficacy and Safety of Opicapone in Parkinson's Disease Add -on to Levodopa Carbidopa Intestinal Gel
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Effect of Drug
Lead sponsor: University Hospital of Ferrara
Sponsor class: OTHER
First posted: 2024-05-29
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomised blinded End-point study
Primary purpose: TREATMENT

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).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluation of motor fluctuations changes
timeFrame: 12 months
measure: Evaluation of dyskinesia changes
timeFrame: 12 months
Secondary outcomes:
measure: Changes in non-motor aspects of patients' daily living experiences
timeFrame: 12 months
measure: Changes in motor aspects of patients' daily living experiences
timeFrame: 12 months
measure: Changes in non-motor symptoms in Parkinson's disease-cognition
timeFrame: 12 months
measure: Neurophysiological outcome
timeFrame: 12 months
Other outcomes:
Locations:
city: Ferrara
country: Italy
facility: University Hospital of Ferrara - Arcispedale Sant'Anna
state: Emilia Romagna
Study officials:
affiliation: Azienda Ospedaliero -Universitaria S. Anna Ferrara
name: Mariachiara Sensi, MD-Phd
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.
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-202022.