EUCTR2015-004796-68-SK进行中（未招募）1 期
An Uncontrolled, Open-Label Extension Study to Evaluate the Long Term Safety, Tolerability, and Maintenance of Effect of BIIB074 (Vixotrigine) in Subjects With Neuropathic Pain From Lumbosacral Radiculopathy
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 403
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •The candidates must meet the following eligibility criteria at enrollment, or at the timepoint specified in the individual eligibility criterion listed:
- •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 concerns
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 323
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 80
排除标准
- •Exclusion Criteria:
- •Candidates will be excluded from study entry if any of the following exclusion criteria exist at enrollment, or at the timepoint specified in the individual criterion listed:
- •1. Had a major protocol deviation regarding inclusion or exclusion criteria for the double--blind 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) visit.
- •5. Other unspecified reasons that, in the opinion of the Investigator or Biogen, make the subject unsuitable for enrollment.
研究者
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