EUCTR2015-004796-68-IT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 in Subjects With Neuropathic Pain From Lumbosacral Radiculopathy - Study to Evaluate the Long Term Safety, Tolerability, and Effect of BIIB074 in Subjects With Neuropa
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 302
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
- 性别
- All
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.
- •3. All women of childbearing potential and all men must practice effective contraception during the study and for 5 weeks for women and 14 weeks for men, after their last dose of study treatment.
- •4. Subjects may take up to 1 permitted medication for neuropathic pain
- •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 Convergence Pharmaceuticals, make the subject unsuitable for enrollment.
- •6. Has met withdrawal criteria for the preceding double-blind phase 2b study for PLSR (Study 1014802-203).
- •7. Is pregnant or lactating (female subjects only).
- •8. Male subjects whose partner is pregnant.
- •9. Has a history of suicide attempt since participating in the preceding double-blind phase 2b study for PLSR (Study 1014802-203).
- •10. Has a history of any liver disease, with the exception of known Gilbert's disease since participating in the preceding double-blind phase 2b study for PLSR (Study 1014802-203).
- •11. Has a history of alcohol or substance abuse (as determined by the Investigator).
- •12. Has a history or risk of seizures or a history of epilepsy, clinically significant head injury, or related neurological disorders.
- •13. Currently has a history of uncontrolled or poorly controlled hypertension.
- •14. Has a history or presence of significant cardiovascular, gastrointestinal, or renal disease, or other condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
- •15. Has a history or presence of any clinically significant abnormality in vital signs, ECG, or laboratory tests or has any medical or psychiatric condition that, in the opinion of the Investigator, may interfere with the study procedures or compromise subject safety.
- •16. Has had an episode of major depression since participating in the preceding double-blind phase 2b study for PLSR (Study 1014802-203).
- •17. Is unable to comply with the permitted and prohibited medications
- •18. Is mentally or legally incapacitated
- •19. Is unable to comply with study requirements
研究者
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