NCT01405833已完成1 期
Phase 1: A Multi-Centered, Randomized, Blinded, Placebo-Controlled, Serial-Cohort, Multiple Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of BG00010 (Neublastin) in Subjects With Sciatica
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Serum drug concentrations of BG00010 as a measure of pharmacokinetics
研究概览
简要总结
The primary objective of the study is to evaluate the safety, tolerability, and pharmacokinetic (PK) profile of 3 intravenous (IV) injections of BG00010 given on 2 fixed schedules; weekly and as frequently as every 48 hours (but no more than 3 times per week).
Secondary objectives of this study in this study population are to explore the repeated-dose immunogenicity of BG00010 and to explore the potential of BG00010 to reduce pain following multiple-dose administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have a diagnosis of unilateral sciatica, determined by the Investigator and as outlined in the protocol. Sciatica symptoms must be present for 3 or more months prior to the Screening Visit.
- •Must rate their pain at >/=40 mm on the 100 mm Visual Analog Scale (VAS) of the Short-Form McGill Pain Questionnaire (SF-MPQ)at the Screening and Baseline Visits.
排除标准
- •History of malignancy or clinically relevant allergies and/or cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic (not related to sciatica), dermatologic, rheumatic/joint, psychiatric, renal, and/or other major disease.
- •History of severe pain as judged by the Investigator, other than that caused by sciatica during the 3 months prior to Screening Visit.
- •Signs or symptoms of peripheral neuropathy, other than symptoms of sciatica during the 3 months prior to Screening Visit.
- •Current generalized myalgia
- •Serum creatinine >1.5 x upper limit of normal (ULN).
- •History of or positive screening test for hepatitis C infection, hepatitis B infection and/or positive for hepatitis B core antibody or positive for human immunodeficiency virus (HIV) antibody. Subjects who are HBsAg negative and HBcAb positive are allowed to participate if they are positive for HBsAb IgG (see the Centers for Disease Control and Prevention's interpretation of the hepatitis B serology panel).
- •Treatment with any prescription medication and/or over the-counter products such as herbal supplements, unless the dose has been stable for 2 weeks prior to the Baseline Visit.
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
研究组 & 干预措施
BG00010 (Neublastin)
Experimental
Participants may be randomized to escalating doses of BG00010
干预措施: BG00010 (Neublastin) (Drug)
Placebo
Placebo Comparator
Participants may be randomised to a matching placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Serum drug concentrations of BG00010 as a measure of pharmacokinetics
时间窗: Throughout the study period- an expected 15 weeks
Number of Participants experiencing Adverse Events
时间窗: Throughout the study period- an expected 15 weeks
次要结局
- Presence of anti-BG00010 antibodies in serum(Throughout the study period- an expected 15 weeks)
- Change in pain as measured by Likert numerical pain rating scale(Every day for 3 consecutive days prior to baseline throughout the study period)
- Change in Visual analog Scale (VAS) of the Short-Form McGill Pain Questionnaire (SF-MPQ)(Throughout the study period at each visit)
研究者
研究点 (1)
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