A Dose-Blinded Extension Study to Evaluate the Long-Term Efficacy, Safety, and Tolerability of UCB0599 in Study Participants With Parkinson's Disease
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 374
- 试验地点
- 96
- 主要终点
- Baseline adjusted Dopamine Transporter Imaging with Single Photon Emission Computed Tomography (DaT-SPECT) whole striatum SBR at PD0055 Month 18
研究概览
简要总结
The purpose of the study is to estimate the pharmacodynamic effects of minzasolmin (UCB0599) on brain pathophysiology in Early-start versus Delayed-start participants originally diagnosed with new onset Parkinson's disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 78 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Study participant has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the study participant's ability to participate in this study
- •A female study participant who tests positive for pregnancy, plans to get pregnant during the participation in the study, or who is breastfeeding
- •Study participant had previously participated in PD0055
- •Study participant meets any withdrawal criteria in PD0053 (NCT04658186)
- •Study participants wearing any kind of implantable active device, including cardiac pacemakers, pumps, and implantable cardioverters, will be excluded from using Digital Health Technology, but may participate in the main study
- •Study participant does not agree to refrain from donating blood or blood products or other body fluids
研究组 & 干预措施
Minzasolmin (UCB0599) High Dose Arm
Participants will receive a predefined high dosage of minzasolmin (UCB0599) during the Treatment Period.
干预措施: Minzasolmin (UCB0599) (Drug)
Minzasolmin (UCB0599) Low Dose Arm
Participants will receive a predefined low dosage of minzasolmin (UCB0599) during the Treatment Period.
干预措施: Minzasolmin (UCB0599) (Drug)
结局指标
主要结局
Baseline adjusted Dopamine Transporter Imaging with Single Photon Emission Computed Tomography (DaT-SPECT) whole striatum SBR at PD0055 Month 18
时间窗: From Baseline up to Month 18
The change from baseline (screening) in mean striatum specific binding ratios (SBR) will be assessed by Dopamine Transporter Imaging with Single Photon Emission Computed Tomography using 123I-Ioflupane as radiopharmaceutical. Baseline will refer to PD0053 (NCT04658186) Screening Visit date.
次要结局
- Incidence of TEAEs leading to withdrawal from study(From Baseline to the Safety Follow-up Visit (Month 31))
- Cumulative Levodopa Equivalent Daily Dose; (LEDD) at PD0055 Month 18(From Baseline up to Month 18)
- Incidence of treatment-emergent adverse event (TEAEs)(From Baseline to the Safety Follow-up Visit (Month 31))
- Incidence of serious adverse events (SAEs)(From Baseline to the Safety Follow-up Visit (Month 31))