Effect of Drug, Parkinson Disease
Conditions
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.
Interventions
DRUGOpicapone 50 mg
Evaluate the addition of the COMT-I, Opicapone, to the Levodopa-Carbidopa intestinal gel in Parkinson's Disease patients with motor fluctuations.
DRUGDuodopa
Evaluate Levodopa-Carbidopa intestinal gel in Parkinson's Disease patients with motor fluctuations.
Sponsors
University Hospital of Ferrara
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Prospective randomised blinded End-point study
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of motor fluctuations changes | 12 months | Changes in MDS-UPDRS part IV from the initial assessment to 12 months follow-up. |
| Evaluation of dyskinesia changes | 12 months | Changes in UDysRS from the initial assessment to 12 months follow-up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neurophysiological outcome | 12 months | Changes of sural amplitude potential through electroneurography from the initial assessment to 12 months follow-up. |
| Changes in non-motor aspects of patients' daily living experiences | 12 months | Changes of MDS-UPDRS I score from the initial assessment to 12 months follow-up. |
| Changes in motor aspects of patients' daily living experiences | 12 months | Changes of of MDS-UPDRS II score from the initial assessment to 12 months follow-up. |
| Changes in non-motor symptoms in Parkinson's disease-cognition | 12 months | Changes of MOCA score from the initial assessment to 12 months follow-up. |
Countries
Italy
Outcome results
None listed