A DOSE-BLINDED EXTENSION STUDY TO EVALUATE THE LONG-TERM EFFICACY, SAFETY, AND TOLERABILITY OF UCB0599 IN STUDY PARTICIPANTS WITH PARKINSON’S DISEASE

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-500424-30-00

Acronym

PD0055

Enrollment

283

Registered

2022-11-29

Start date

2022-12-28

Completion date

2025-03-19

Last updated

2025-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson’s disease

Brief summary

Baseline adjusted Dopamine Transporter Imaging with Single Photon Emission Computed Tomography (DaT-SPECT) whole striatum specific binding ratio (SBR) at PD0055 Month 18

Detailed description

- Cumulative Levodopa Equivalent Daily Dose; (LEDD) at PD0055 Month 18 - Incidence of treatment-emergent adverse event (TEAEs) - Incidence of serious adverse events (SAEs) - Incidence of TEAEs leading to withdrawal from study

Interventions

DRUGUCB0599 PRD4385815

DRUGPlacebo matching UCB0599 and without active substance

DRUGIODINE IOFLUPANE (123I)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Secondary

Measure	Time frame
- Cumulative Levodopa Equivalent Daily Dose; (LEDD) at PD0055 Month 18 - Incidence of treatment-emergent adverse event (TEAEs) - Incidence of serious adverse events (SAEs) - Incidence of TEAEs leading to withdrawal from study	—

Primary

Measure	Time frame
Baseline adjusted Dopamine Transporter Imaging with Single Photon Emission Computed Tomography (DaT-SPECT) whole striatum specific binding ratio (SBR) at PD0055 Month 18	—

Countries

France, Germany, Italy, Netherlands, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026