A double-blind, placebo-controlled, randomized dose ranging trial to determine the safety and efficacy of three dose levels of EMA401 in reducing 24-hour average pain intensity score in patients with post-herpetic neuralgia - EMPHENE

ovartis Pharma AG0 个研究点目标入组 129 人开始时间: 2017年5月18日最近更新: 2020年5月11日

研究概览

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•At the time of Screening, have documented diagnosis of PHN (ICD-10 code B02.29), defined as pain in the region of the rash persisting for more than 6 months after onset of herpes zoster rash.
•Be assessed as suffering from moderate to severe neuropathic pain across the Screening epoch (NRS = 4).
•Patients must have documented past and/or ongoing inadequate treatment response (having insufficient pain relief with treatment or inability to tolerate) to at least 2 different prescribed therapies commonly used to treat and considered effective by the Investigator for the treatment of PHN.
•Other protocol-defined inclusion 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 180
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 180

•History or current diagnosis of electrocardiogram (ECG) abnormalities indicating significant risk of safety for patients participating in the study.
•Major depressive episode within 6 months prior to Screening and/or a history of diagnosed recurrent major depressive disorder according to Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-V) diagnostic criteria.
•Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant.
•Have evidence of significant renal insufficiency or pre-existing liver condition.
•Have platelets = 100 x 10^9/L, or neutrophil count < 1.2 x 10^9/L (or equivalent), hemoglobin = 100 g/L for women or hemoglobin = 110 g/L for men.
•Patients who have a known diagnosis of diabetes and are stable on medication with a hemoglobin A1c > 8%. Those who do not have a known diagnosis of diabetes with a hemoglobin A1c > 7%.
•Have previously received herpes zoster vaccine.
•Patient is unwilling or unable to complete daily e-Diary.
•Other protocol-defined exclusion criteria may apply.

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