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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06432309
Other study ID # 480/2022/Oss/AOUFe
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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