NCT04990284

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

A Randomized, Parallel Group, Multicentre, Multinational, Prospective, Open-label Exploratory Study to Evaluate the add-on Effect of Opicapone 50 mg or Levodopa 100 mg as First Strategy for the Treatment of Wearing-off in Patients With Parkinson's Disease.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 106 (actual)
• Sponsor: Bial - Portela C S.A. · Industry
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study consists of a one-week screening period, four weeks of open-label treatment and two weeks of post-study follow-up. The total study duration for each patient will be approximately 7 weeks

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
DRUG	Opicapone	50 mg hard capsules. Oral administration, once-daily at bedtime, at least 1 hour before or after L-DOPA/carbidopa or benserazide (L-DOPA/DDCI).
DRUG	L-DOPA/DDCI	L-DOPA/carbidopa or benserazide (L-DOPA/DDCI), 100/25 mg, oral administration

Timeline

• Start date: 2021-11-29
• Primary completion: 2023-04-04
• Completion: 2023-04-04
• First posted: 2021-08-04
• Last updated: 2025-03-12

Locations

25 sites across 5 countries: Germany, Italy, Portugal, Spain, United Kingdom