EUCTR2015-004775-78-IT进行中（未招募）1 期
A Randomized, Double-Blind, Placebo-Controlled, Parallel-GroupStudy to Evaluate the Efficacy and Safety of BIIB074 in Subjects With Neuropathic Pain From Lumbosacral Radiculopathy - A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Sa
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 424
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
- •Key Inclusion Criteria:
- •- Men and women aged 18 to 75 years inclusive
- •- Has body weight =50 kg for men and =45 kg for women
- •- Must have diagnosis of neuropathic PLSR
- •- Has duration of neuropathic (leg) pain of at least 6 months before Screening
- •Other protocol-defined inclusion/exclusion criteria may apply.
- •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 400
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 104
排除标准
- •Key Exclusion Criteria:
- •- Has pain of a different type in the legs (e.g. due to arthritis) that may interfere with the assessment of neuropathic pain in the legs.
- •- Has planned surgical intervention for PLSR within the duration of the study.
- •- Has a history of peripheral neuropathy (e.g., due to diabetes, alcohol consumption, other causes, or idiopathic) or evidence of peripheral neuropathy upon neurological examination
- •- Has a history or risk of seizures or a history of epilepsy, clinically significant head injury, or related neurological disorders
- •- Unable to discontinue prior to Day 1 any prohibited concomitant monoamine oxidase inhibitors (MAOIs), potent CYP3A4 inducers or inhibitors, potent UGT inducers or inhibitors, including over the counter preparations, herbal remedies, vitamin, mineral supplements, food or drinks as detailed in 11.5.1.2
- •- Is pregnant or lactating (female subjects only).
- •- Male subject whose partner is pregnant
- •- Has used paracetamol/acetaminophen at a daily dose of equal to or more than 2.5g/day on 5 or more days during 7 consecutive days in the run in phase.
- •- Other protocol-defined inclusion/exclusion criteria may
研究者
相似试验
进行中（未招募）
不适用
Efficacy and Safety of REGN727/SAR236553 Versus Placebo in Patients with Heterozygous Familial Hypercholesterolemia Not Adequately Controlled with Their Lipid-Modifying TherapyEUCTR2012-001222-95-NLRegeneron Pharmaceuticals Inc.250
进行中（未招募）
1 期
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Once-Daily, Intranasal Administration of GW685698X Aqueous Nasal Spray 100mcg for 4 Weeks in Adult and Adolescent Subjects (12 years of age and older) with Vasomotor/Idiopathic RhinitisVasomotor/Idiopathic RhinitisEUCTR2004-004744-43-NOGlaxoSmithKline Research & Development Ltd347
进行中（未招募）
1 期
Baricitinib in Patients with COVID-19 InfectioCOVID-19 infectionMedDRA version: 23.0Level: PTClassification code 10051905Term: Coronavirus infectionSystem Organ Class: 10021881 - Infections and infestationsEUCTR2020-001517-21-DEEli Lilly and Company1,400
进行中（未招募）
1 期
ODYSSEY Outcomes: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With AlirocumabMedDRA version: 20.0Level: PTClassification code 10051592Term: Acute coronary syndromeSystem Organ Class: 10007541 - Cardiac disordersAcute coronary syndromeEUCTR2011-005698-21-DEsanofi-aventis Recherche & Développement18,600
进行中（未招募）
1 期
Efficacy and Safety of SAR236553 (REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients with Heterozygous Familial HypercholesterolemiaEUCTR2011-005109-56-NLsanofi-aventis Recherche & Développement486