drugset / Trial / NCT04990284

eArly levoDopa With Opicapone in Parkinson's paTients wIth motOr fluctuatioNs.

NCT04990284

Phase 4 Completed 106 enrolled Bial - Portela C S.A.
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a randomized, parallel group, multicentre, multinational, prospective, open-label exploratory study in Parkinson's disease (PD) patients to evaluate the add-on efficacy of opicapone 50 mg or an extra dose of levodopa (L-DOPA) 100 mg as first strategy for the treatment of wearing-off.

Timeline

Start
2021-11-29
Primary completion
2023-04-04
Completion
2023-04-04

Drugs

EvaluationDrugModalityDoseRoute
Subject L-DOPA/DDCI Unknown 50 mg Oral
Subject Levodopa Small molecule 100 mg Oral
Background Carbidopa Unknown 25 mg Oral
Background benserazide Small molecule 25 mg Oral

Indications