NCT00120120
已完成
2 期
A Multicenter, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Lenalidomide in the Treatment of Painful Lumbar Radiculopathy
概览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 181
- 试验地点
- 23
- 主要终点
- Change from baseline in RAD pain intensity ratings using PI-NRS
概览
简要总结
The purpose of this multicenter, double-blind, placebo-controlled study is to evaluate the efficacy and safety of lenalidomide in the treatment of painful lumbar radiculopathy.
详细描述
Study Duration: Pre-randomization Phase: 14 days; Treatment Phase: 12 weeks; Extension Phase: Ongoing; Total Study Duration: Up to 14 weeks + the duration of the extension phase
For each subject, the study consists of three phases: Pre-randomization phase (14 days), Treatment Phase (12 weeks) and an extension phase where subjects have the opportunity to receive lenalidomide treatment as long as benefit is derived from the drug. Subjects who complete all 12 weeks of the treatment phase may be eligible to initiate (subjects randomized to receive placebo in the treatment phase) or continue to receive lenalidomide therapy (subjects randomized to receive lenalidomide in the treatment phase) in the extension phase. Subjects may continue in the extension phase as long as a benefit is derived from the drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Age 18 years or greater at the time of signing the informed consent form
- •Clinical diagnosis of painful radiculopathy which is based on the presence of pain in the distribution of the sciatic nerve or L4, L5 or S1 dermatomes. The pain must be primarily in the lower leg and radiate to the ankle or foot.
- •History of painful radiculopathy involving one or both of the distal lower extremities for greater than or equal to 6 months
- •MRI or CT scan within the past 2 years or more recent if symptoms have changed
- •Positive straight leg raising (SLR) test in the index ipsilateral leg (pain radiating below the knee at an elevation of \<60 degrees). In the presence of bilateral leg pain, the leg with the most severe pain will be designated the index leg.
- •Screening (Visit 1): Radiculopathy PI-NRS score must be at least 5 on an 11-point (0-10) PI-NRS
- •Randomization (Visit 2): Average radiculopathy PI-NRS score for randomization purposes will be based on AM and PM assessments made during the 7 days prior to randomization:
- •At least eight radiculopathy PI-NRS scores during this 7-day period are required and
- •Average radiculopathy PI-NRS score during this period must be at least 5 on an 11-point (0-10) PI-NRS.
- •Stable doses of tricyclic antidepressants, AEDs, mexiletine hydrochloride, dextromethorphan, capsaicin, NSAIDs, opioids or other medications (including prn radiculopathy medication usage) that could affect symptoms of painful radiculopathy for at least 28 days prior to randomization (Visit 2).
排除标准
- •Pain localized in the low back or other sites that is a greater component of subject's total pain problem than lower leg and foot pain
- •Ankle or foot problems, which could interfere with the assessment of radiculopathy pain
- •Unstable lumbar spinal segment
- •Evidence of an acute operable lesion or tumor based on CT-scan or MRI results
- •Current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematological, endocrine, pulmonary, cardiac or neurological disease
- •Any medical condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
- •Presence of a clinically significant psychiatric diagnosis(es) that would impair reliable study participation
- •History of deep vein thrombosis (DVT) or stroke in the past 5 years
- •History of low back or lumbar spinal surgery
- •Documented metabolic or toxic peripheral neuropathies
研究组 & 干预措施
1
Experimental
干预措施: Lenalidomide (CC-5013) (Drug)
2
Experimental
干预措施: Lenalidomide (CC-5013) (Drug)
结局指标
主要结局
Change from baseline in RAD pain intensity ratings using PI-NRS
时间窗: baseline to week 12
次要结局
- Safety (type, frequency, severity, and relationship to study drug)(change from baseline)
- Change from baseline in the PM PI NRS value(change from baseline)
- Change from baseline in the AM PI NRS value(change from baseline)
- Change from baseline inactivity level rating using an NRS(change from baseline)
- Change from baseline in SLR angle of elevation without induced pain(change from baseline)
- Change from baseline in the SF-MPQ total score and subscale scores(change from baseline)
- Changes from baseline in the BPI score relative to baseline pain ratings and interference scales(change from baseline)
- Changes from baseline in the POMS total mood score and six dimension subscale scores(change from baseline)
- Change from baseline in the PDI score(change from baseline)
- Change from baseline in the Modified Oswestry Low Back Pain Disability Questionnaire total score(change from baseline)
- Patient global impression of change(change from baseline)
研究者
研究点 (23)
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