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7月19日最近更新: 2020年6月2日

试验速览

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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 /
•analgesics commonly used to treat and considered effective for the
•treatment of PHN.
•Patients must be willing to complete daily eDiary.
•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

•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 unless they are using highly effective
•methods of contraception during dosing and for 3 days after stopping
•study medication.
•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%.
•Other protocol-defined exclusion criteria may apply.

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