Efficacy and Safety of Opicapone in Parkinson's Disease Add -on to Levodopa Carbidopa Intestinal Gel
Overview
- Phase
- Not Applicable
- Intervention
- Duodopa
- Conditions
- Parkinson Disease
- Sponsor
- University Hospital of Ferrara
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- Evaluation of motor fluctuations changes
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 ).
Exclusion Criteria
- •Hoehn \& Yahr (H\&Y) \>4,
- •Cognitive decline (MOCA\< 17),
- •more than 30 months after LCIG positioning,
- •not compliant with treatment and follow-up visits.
Arms & Interventions
nOPC: Duodopa (Levodopa/carbidopa intestinal gel) in monotherapy
Levodopa carbidopa intestinal gel infusion. Diurnal infusion from 7.a.m to 11 p.m.
Intervention: Duodopa
add-OPC: Duodopa plus OPC therapy
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)
Intervention: Opicapone 50 mg
add-OPC: Duodopa plus OPC therapy
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)
Intervention: Duodopa
Outcomes
Primary Outcomes
Evaluation of motor fluctuations changes
Time Frame: 12 months
Changes in MDS-UPDRS part IV from the initial assessment to 12 months follow-up.
Evaluation of dyskinesia changes
Time Frame: 12 months
Changes in UDysRS from the initial assessment to 12 months follow-up.
Secondary Outcomes
- Changes in non-motor aspects of patients' daily living experiences(12 months)
- Neurophysiological outcome(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)