NCT04054024Unknown2 期
A Placebo-Controlled, Double-Blind, Randomized, Proof-of-Concept Study to Evaluate the Efficacy and Tolerability of Erenumab in Patients With Trigeminal Neuralgia
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Proportion of subjects classified as responders at the end of the evaluation period.
研究概览
简要总结
A placebo-controlled, double-blind, randomized proof-of-concept study to evaluate the efficacy and tolerability of the CGRP receptor antibody erenumab in treating pain experienced by subjects with TN.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Placebo is saline
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A diagnosis of primary TN (idiopathic or classical) according to criteria of The Interna-tional Classification of Headache Disorders 3rd edition (1).
- •Age between 18 and 85 years.
- •Subjects must have a minimum mean of three TN related pain paroxysms per day with a mean ADP of 4 to 10, inclusive, on the 11-point NRS (0= no pain; 10= maximum pain imaginable) during the 7-day screening phase to enter the baseline phase.
- •Subjects must have a minimum mean of three TN related pain paroxysms per day with a mean ADP of 4 to 10, inclusive, on the 11-point NRS (0= no pain; 10= maximum pain imaginable) during the 4-week baseline phase to enter the treatment phase (to be randomized).
- •Fertile women must use safe contraceptives and present with a negative u-HCG at visit
- •Safe contraceptives are defined as intra-uterine devices, contraceptive pills or implants and surgical sterilization.
排除标准
- •Significant cardiovascular and cerebrovascular disease such as ischemic heart disease, previous myocardial infarction or previous stroke or transient ischemic attack, major CVD interventions.
- •Language difficulties.
- •Poor compliance, i.e. unlikely to be able to complete all protocol required study visits or procedures, and/or to comply with all required study procedures to the best of the sub-ject's and investigator's knowledge.
- •Severe psychiatric disease.
- •Anamnestic or clinical symptoms of any kind that are deemed relevant for study partici-pation by the physician who examines the patient.
- •Taking any TN-medication, where the prescribed daily dose has changed within 2 weeks prior to the baseline period (refer to section 6.4 for the list of these medications).
- •Pregnant or breastfeeding, or is a female expecting to conceive during the study, includ-ing through 4 weeks after treatment.
- •Female subject of childbearing potential who is unwilling to use an acceptable method of effective contraception during the study. Acceptable methods of effective birth control include not having intercourse (true abstinence, when this is in line with the preferred and usual lifestyle of the subject), hormonal birth control methods (pills, shots/injections, implants, or patches), intrauterine devices, surgical contraceptive methods (vasectomy with medical assessment of the surgical success of this procedure or bilateral tubal ligation), or two barrier methods (each partner must use one barrier method) with spermicide - males must use a condom with spermicide; females must choose either a diaphragm with spermicide, OR cervical cap with spermicide, OR contraceptive sponge with spermicide. Female subjects not of childbearing potential are defined as any female who: is post-menopausal by history, defined as:
- •Age ≥ 55 years with cessation of menses for 12 or more months, OR Age < 55 years but no spontaneous menses for at least 2 years, OR Age < 55 years and spontaneous menses within the past 1 year, but currently amenorrheic (eg, spontaneous or secondary to hysterectomy), AND with postmenopausal gonadotro-pin levels (luteinizing hormone and follicle-stimulating hormone levels > 40 IU/L) or postmenopausal estradiol levels (< 5 ng/dL) or according to the definition of "postmeno-pausal range" for the laboratory involved. OR o Underwent bilateral oophorectomy OR o Underwent hysterectomy OR o Underwent bilateral salpingectomy.
- •Known sensitivity to any component of erenumab.
- •Member of investigational site staff or relative of the investigator.
研究组 & 干预措施
Active drug
Active Comparator
干预措施: Erenumab (Drug)
Placebo
Placebo Comparator
干预措施: Placebos (Drug)
结局指标
主要结局
Proportion of subjects classified as responders at the end of the evaluation period.
时间窗: 4 weeks after randomization
A subject who meets the following criterion will be classified as a responder: Has a reduction of ≥ 30% in mean average daily pain intensity score (mean ADP) assessed using the 11-point numerical rating scale (NRS) during the evaluation period (week 1-4) compared with baseline (weeks -4 to -1). Patients that are protocol violators, e.g., patients having to increase current medications or undergoes surgery in the evaluation period as well as pa-tients who drop out due to worsening of symptoms or side effects will be recorded as non-responders.
次要结局
- Secondary outcome measures(4 weeks after randomization)
研究者
Stine Maarbjerg, MD
Principal investigator
Danish Headache Center
研究点 (1)
Loading locations...
相似试验
已完成
不适用
A Clinical Study to Evaluate Efficacy and Safety of a Cosmetic Product in the Treatment of Facial LinesFine LinesWrinklesPhotoagingNCT04545970Revision Skincare56
招募中
不适用
A Study to Evaluate Efficacy of EB-PA as Protein Amplifier for Skeletal Muscle Strength & GrowthSkeletal Muscle Strength & GrowthNCT06127849Vedic Lifesciences Pvt. Ltd.138
进行中（未招募）
2 期
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary FibrosisPulmonary Fibrosis Secondary to Systemic SclerosisPulmonary Fibrosis, Interstitial Lung DiseaseInterstitial Lung Disease Due to Connective Tissue Disease (Disorder)Interstitial Lung Disease in Patients With Rheumatoid ArthritisInterstitial Lung Disease With Progressive Fibrotic Phenotype in Diseases Classified ElsewhereInterstitial Lung Disease With Systemic SclerosisPulmonary FibrosisHypersensitivity PneumonitisInterstitial Lung DiseaseNCT06329401Avalyn Pharma Inc.375
Unknown
2 期
Study to Evaluate Efficacy and Safety of NDS-446 in Men With Lower Urinary Tract Symptoms (LUTS)Lower Urinary Tract SymptomsNCT02808013Naturex-Dbs116
招募中
2 期
A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetic Profile of Genakumab Injection in Patients With Connective Tissue Disease-associated Interstitial Lung DiseaseSystemic Sclerosis Associated Interstitial Lung DiseaseRheumatoid Arthritis Associated Interstitial Lung Disease (RA-ILD)Systemic Sclerosis Associated Interstitial Lung Disease (SSc-ILD)NCT06189495Changchun GeneScience Pharmaceutical Co., Ltd.30