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

U

University Hospital of Ferrara

Status

Completed

Conditions

Parkinson Disease
Effect of Drug

Treatments

Drug: Duodopa
Drug: Opicapone 50 mg

Study type

Interventional

Funder types

Other

Identifiers

NCT06432309
480/2022/Oss/AOUFe

Details and patient eligibility

About

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).

Full 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.

Enrollment

22 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

22 participants in 2 patient groups

nOPC: Duodopa (Levodopa/carbidopa intestinal gel) in monotherapy
Other group
Description:
Levodopa carbidopa intestinal gel infusion. Diurnal infusion from 7.a.m to 11 p.m.
Treatment:
Drug: Duodopa
add-OPC: Duodopa plus OPC therapy
Active Comparator group
Description:
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)
Treatment:
Drug: Duodopa
Drug: Opicapone 50 mg

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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