JPRN-jRCT2061220090招募中2 期
Safety and efficacy of Goreisan in combination with carbamazepine in patients with trigeminal neuralgia: A physician-initiated double-blind, randomized, placebo-controlled, Phase II clinical trial - HOG-503-001
Ogawa Keiko0 个研究点目标入组 24 人开始时间: 2023年1月30日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
入选标准
- •Select patients who meet all of the following criteria
- •(1) Patients whose consent has been obtained in writing
- •(2) Patients who are at least 18 years of age at the time consent is obtained, regardless of gender
- •(3) Patients who can use a telemedicine system
- •(4) Patients diagnosed with idiopathic trigeminal neuralgia or typical trigeminal neuralgia based on the diagnostic criteria according to The International Classification of Headache Disorders (ICHD, 3DE EDTION: ICHD-3)
- •(5) Patients who meet the following conditions for carbamazepine for trigeminal neuralgia at the time of enrollment
- •-Receiving carbamazepine for at least 1 month consecutively
- •-Daily dosage has remained unchanged for 2 weeks prior to enrollment.
- •(6) Patients with inadequate pain control for trigeminal neuralgia even with carbamazepine administration*.
- •*Average weekly VAS 30 or greater for pain attacks in 1 consecutive week within 3 weeks prior to enrollment
- •(7) Women of childbearing potential with a confirmed negative pregnancy test within 14 days prior to enrollment
- •(8) For women of childbearing potential or with a partner of childbearing potential, patients who have agreed to use an appropriate contraceptive method from the time consent is obtained to 6 months after the last dose of protocol treatment
排除标准
- •(1) Patients diagnosed with secondary trigeminal neuralgia
- •(2) Patients with a history of allergic reaction to any of the ingredients in Goreisan
- •(3) Patients with a history of Goreisan, Inchin goreisan, Tyoreitou, or Ireitou.
- •(4) Patients who are using any of the following drugs within 30 days prior to registration
- •Drugs that have been reported to be effective for trigeminal neuralgia
- •Drugs contraindicated with carbamazepine
- •Kampo and crude drug containing the ingredients of Goreisan
- •(5) Patients on drugs that are contraindicated with carbamazepine
- •(6) Patients undergoing treatment for malignant tumors
- •(7) Pregnant or breast-feeding women
- •(8) Patients who have undergone major surgery within 8 weeks prior to screening or who are planned to undergo surgery during the study period
- •(9) Patients with clinically significant cardiac disease (myocardial infarction within 1 year, unstable ischemic heart disease, NYHA classification III / IV left ventricular failure, arrhythmia, and uncontrolled hypertension, etc.), hematological disorders, neurological diseases, psychiatric disorders, etc. or porphyria
- •(10) Patients with the following laboratory values at screening
- •- Hemoglobin level: less than 10 g/dL
- •- Platelet count: less than 100000/mm3
- •- White blood cell count: <3000/mm3
- •- AST and ALT: > 1.5 times the upper limit of the institutional reference value (ULN)
- •- Serum creatinine level: ULN > 1.5 times the ULN
- •(11) Patients with chronic pain other than trigeminal neuralgia that the investigator or subinvestigator diagnoses may affect the evaluation of the study
- •(12) Patients who have received other investigational drugs within 30 days of enrollment in the study
- •(13) Other patients who the investigator determines to be inappropriate as subjects for the study.
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