A Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study Using a Bayesian Adaptive Design to Assess the Efficacy, Safety, Tolerability, and Serum Exposure of Multiple Doses of BG00010 (Neublastin) in Subjects With Painful Lumbar Radiculopathy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 183
- 试验地点
- 1
- 主要终点
- Change from Baseline in the mean 24-hour average general pain intensity (AGPI) score
研究概览
简要总结
The primary objective of the study is to assess the efficacy of Intravenous (IV) BG00010 (Neublastin) in improving pain in painful lumbar radiculopathy participants when administered 3 times per week for 1 week.
The secondary objectives of this study in this study population are as follows: To explore the duration of the effect of BG00010 in improving pain; To explore the dose response curve on pain reduction; To assess the safety and tolerability of BG00010; To assess the serum exposure to BG00010.
详细描述
During the study, frequent assessment of allocation probability will be conducted to guide subsequent randomization of participants into dose groups.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body weight ≤133 kg.
- •Leg pain radiating, diagnosed as being due to painful lumbar radiculopathy or lumbosacral radiculopathy, the diagnosis of which occurred within ≥6 months and ≤5 years of the time of randomization.
- •Objective, documented evidence of painful lumbar radiculopathy involvement
- •Lower back pain
- •Male and female subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 3 months after their last dose of study treatment.
排除标准
- •History of or positive test result at screening for human immunodeficiency virus, or for hepatitis C virus antibody, or current Hepatitis B infection.
- •Clinically significant diseases or conditions as determined by the investigator.
- •Major surgery within 30 days prior to the Screening Visit or that is scheduled to occur during the study.
- •Previous participation in a study with neurotrophic factors (e.g., nerve growth factor).
- •Participation in a study with another investigational drug or approved therapy for investigational use within 3 months prior to Day
- •Other unspecified reasons that, in the opinion of the Investigator or Biogen Idec Inc. (Biogen Idec), make the subject unsuitable for enrollment
- •NOTE: Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
BG00010
Administered as an IV injection at various dose levels 3 times per week for 1 week
干预措施: BG00010 (Drug)
Placebo
Matched placebo IV injection 3 times per week for 1 week
干预措施: Placebo (Drug)
结局指标
主要结局
Change from Baseline in the mean 24-hour average general pain intensity (AGPI) score
时间窗: At the end of treatment period (Day 6-10)
次要结局
- Change from Baseline in the mean 24-hour average back pain intensity (ABPI) score(At the end of the treatment period (day 6-10))
- Change from Baseline in the mean 24-hour average leg pain intensity score (ALPI)(At the end of the treatment period (day 6-10))
- Change from Baseline in the individual mean 24-hour average general pain intensity (AGPI)(Up to week 5)
- Change from Baseline in the individual mean 24-hour average back pain intensity (ABPI)(Up to week 5)
- Change from Baseline in the individual mean 24-hour average leg pain intensity (ALPI)(Up to week 5)
- Maximum observed serum concentration (Cmax) of BG00010(Up to Day 5)
- Number of participants experiencing adverse events (AEs)(Up to week 9)
- Number of participants experiencing serious adverse events (SAEs)(Up to week 9)
- Change from Baseline in Incidence of neutralizing antibodies in serum(Up to week 9)