A Phase 3, Double Blind, Randomized, Placebo Controlled, Parallel Group, Multicenter Clinical Study of Eslicarbazepine Acetate in Post-Herpetic Neuralgia

BIAL – PORTELA & Ca, S.A.0 个研究点目标入组 392 人2010年5月31日

概览

阶段: 不适用
干预措施: 未指定
疾病 / 适应症: 未指定
发起方: BIAL – PORTELA & Ca, S.A.
入组人数: 392
状态: 进行中（未招募）
最后更新: 10年前

概览研究者入排标准结局指标相似试验

概览

简要总结

暂无简介。

注册库

who.int

开始日期

2010年5月31日

结束日期

待定

最后更新

10年前

研究类型

Interventional clinical trial of medicinal product

性别

All

研究者

发起方

BIAL – PORTELA & Ca, S.A.

入排标准

入选标准

•1\. Male and female outpatients aged 18 years or older. Female subjects are of nonchildbearing potential, defined as surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or at least 2 years postmenopausal (spontaneous amenorrhea for at least 24 months before Visit 1\), or if of childbearing potential,
•subjects agree to use a medically acceptable nonhormonal method of contraception (Section 3\.8\.7\).
•2\. Experiencing pain for at least 6 months after the healing of a herpes zoster skin rash. Subjects with PHN involving the trigeminal nerve must have medical documentation of a history of herpes zoster lesions, to avoid enrolling subjects with trigeminal neuralgia of mechanical etiology.
•3\. A mean score between 4\.0 and 9\.0, inclusive, on the 24 hour average pain intensity assessment; the mean is determined by averaging all available daily scores from the 24 hour average pain assessment in the subject eDiary from the last 7 days before Visit 3\. The period between Visit 2 and Visit 3 can vary between 7 to 10 days. To be randomly assigned, a subject must have at least 5 assessments of 24 hour average pain from the last 7 days prior to randomization.
•4\. A subject rated score at Visit 3 of 40 mm or more on a 100 mm VAS for post herpetic pain during the previous 24 hours.
•5\. Daily eDiaries must be completed for at least 70% of the 7 to 10 days between Visit 2 and Visit 3 (ie, 5 of 7 days, 6 of 8 days, 7 of 9 days, or 7 of 10 days).
•6\. If not used to treat PHN, subjects are permitted to take nonsteroidal anti\-inflammatory drugs and selective serotonin reuptake inhibitors if they were kept on a stable dose for 1 month prior to Screening and are foreseen to remain stable throughout the study.
•7\. Competent and able to freely give own informed consent.
•8\. A degree of education and understanding sufficient to communicate intelligibly with the investigator and other study center staff.
•9\. Considered reliable and agree to keep all appointments for protocol required study visits, tests, and procedures.

排除标准

•1\.Historical exposure to drugs known to cause neuropathy, such as vincristine, or a history of a medical condition, including pernicious anemia and hypothyroidism, that could have caused neuropathy.
•2\.Other chronic pain conditions not associated with PHN. However, subjects will not be excluded if all the following criteria apply:
•Pain is located in a different region of the body,
•Pain intensity is not greater than the pain intensity of PHN, and
•Subject can assess PHN pain independently of the other pain condition.
•3\. Significant skin lesions (active infection, ulcer, etc) that could interfere with pain assessment.
•4\. Known intolerance to ESL or to other carboxamide derivatives (eg, carbamazepine or oxcarbazepine) or frequent or severe allergic reactions with multiple medications.
•5\. Subjects who previously participated in a clinical study with ESL.
•6\. Current or previous (within the past year) axis 1 diagnosis of major depressive disorder, mania, bipolar disorder, psychosis, dysthymia, generalized anxiety disorder, alcohol abuse, history of suicide attempt, or eating disorders according to Diagnostic and Statistical Manual of Mental Disorders, 4th edition, text revision (DSM
•IV) American Psychiatric Association, 2000 criteria, as determined by the investigator.