NL-OMON42982撤回2 期
An Uncontrolled, Open-Label Extension Study to Evaluate the Long-Term Safety, Tolerability, and Maintenance of Effect of BIIB074 in Subjects WithNeuropathic Pain From Lumbosacral Radiculopathy - Open-Label study to evaluate long-term effects of BIIB074 from PLSR
Convergence Pharmaceuticals Ltd., a Biogen company0 个研究点目标入组 28 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 入组人数
- 28
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •1. Is able to understand the purpose and risks of the study and provide signed and dated
- •informed consent and authorization to use confidential health information in accordance
- •with national and local subject privacy regulations.
- •2. Has completed Study 1014802-203 through the Week 14 (Day 99) visit. Subjects who
- •discontinued double-blind study treatment but continued to return for study visits through
- •Week 14 (Day 99) and document their pain scores are eligible unless there are safety
排除标准
- •1. Had a major protocol deviation regarding inclusion or exclusion criteria for the doubleblind
- •Phase 2b study (Study 1014802-203).
- •2. Had a treatment-related AE or SAE that would pose an increased risk for continued
- •treatment with BIIB074, or discontinued study treatment in the double-blind Phase 2b
- •study (Study 1014802-203) due to an AE or SAE.
- •3. Did not return for study visits through Week 14 (Day 99) after discontinuing treatment in
- •the double-blind phase of the Phase 2b study.
- •4. Is unable to enroll in the 1014802-204 Study on the 1014802-203 Week 14 (Day 99)
- •5. Other unspecified reasons that, in the opinion of the Investigator or Convergence
- •Pharmaceuticals, make the subject unsuitable for enrollment.
研究者
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