2022-502207-30-00撤回2 期
A Phase IIa, Open Label Study to Evaluate the Safety of Afamelanotide in Patients with Early Parkinson's Disease
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Assessment of Treatment Emergent Adverse Events including clinically significant changes in laboratory results.
研究概览
简要总结
- Evaluate the safety of afamelanotide in patients with early PD following treatment with afamelanotide
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Phase IIa Early Parkinson's Disease Study
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Patient diagnosed with PD less than three years prior to first screening visits and not yet requiring dopaminergic medication nor expected to within three months of enrolment.
- •40-85 years old
排除标准
- •History of drug abuse, licit or illicit.
- •Participation in any clinical intervention study during the six weeks before the study screening period.
- •Any medical condition or illness in the four weeks before the study screening which may interfere with the study protocol or not suitable for study participation in the opinion of the Investigator.
- •Heavy alcohol consumption.
- •Current cigarette smokers.
- •Any personal or immediate family history of melanoma or personal history of dysplastic nevus syndrome
- •Known allergy or anaphylaxis to adrenocorticotropic hormone (ACTH) or melanocortins
- •Any evidence of hepatic insufficiency or renal impairment.
- •Female who is pregnant or lactating.
- •Females of child-bearing potential not using highly effective contraceptive measures, for up to three months after the last injection administration.
- •Sexually active men with a partner of child-bearing potential who is not using highly effective contraceptive measures.
结局指标
主要结局
Assessment of Treatment Emergent Adverse Events including clinically significant changes in laboratory results.
Assessment of Treatment Emergent Adverse Events including clinically significant changes in laboratory results.
次要结局
- Changes in α-synuclein levels in plasma from baseline (Day 1) to Day 56±2
- Changes in inflammation biomarker in plasma from baseline (Day 1) to Day 56±2
- Changes in cognition from baseline (Day 1) to Day 56±2
- Changes in the NM in the MRI series from screening to Day 56±2
- Changes in clinical improvement baseline (Day 1) to Day 56±2
研究者
Information
Scientific
Clinuvel Europe Limited
研究点 (1)
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