Civamide Nasal Spray for the Treatment of Postherpetic Neuralgia of the Trigemina

西维酰胺鼻喷雾剂治疗三叉神经带状疱疹后神经痛

• 批准号: 8545911
• 负责人: Scott B Phillips
• 金额: $ 19.56万
• 依托单位: WINSTON PHARMACEUTICALS, INC.
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-09-15 至 2015-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8545911
• 关键词: Accounting; Adult; Adverse effects; Adverse event; Affect; Agreement; Area; Burn injury; Chronic; Clinical; Clinical Research; Cluster Headache; Communities; Controlled Study; Development; Disease; Disease Outbreaks; Dose; Double-Blind Method; Drug Formulations; Drug Interactions; Drug Kinetics; Elderly; Enrollment; Episodic Cluster Headaches; Esthesia; Face; Facial Neuralgia; Frequencies; Funding; Goals; Grant; Headache; Headache Disorders; Herpes zoster disease; Infection; Lead; Licensing; Measurable; Measures; Mediating; Medical; Migraine; Nerve; Nerve Endings; Neurologist; Neurotransmitters; Nose; Orphan Drugs; Outcome; Pain; Patient Care; Patients; Pharmaceutical Preparations; Pharmacologic Substance; Phase; Population; Postherpetic neuralgia; Randomized; Rare Diseases; Research; Safety; Scalp structure; Secondary pain; Serious Adverse Event; Sleep; Sleep disturbances; Small Business Innovation Research Grant; Structure of mucous membrane of nose; Text; Therapeutic; Therapeutic Effect; Time; Trigeminal nerve structure; absorption; chronic pain; commercialization; diaries; effective therapy; experience; innovation; novel; novel strategies; phase 2 study; phase 3 study; primary outcome; programs; receptor; research and development; treatment duration

DESCRIPTION (provided by applicant): The project is the initial proof of concept clinical study of Civamide Nasal Spray for the treatment of postherpetic neuralgia (PHN) of the trigeminal nerve [(TN), a severely disabling facial pain syndrome]. Civamide Nasal Spray as a treatment for PHN of the [TN] has previously been granted orphan drug designation. If this study is successful in the treatment of PHN of the [TN], further clinical development will proceed, i.e., Phase 2 and Phase 3 studies to support the filing of a New Drug Application. Currently, all approved medications for treating PHN of the [TN] are systemically acting drugs. Civamide Nasal Spray is unique in that it exerts its therapeutic effect locally without systemic absorption [being detected in a pharmacokinetic study.8] The availability of a safe and effective medication for PHN of the [TN] for these patients, i.e., Civamide Nasal Spray, will thus fill an unmet medical need. Civamide, a TRPV-1 receptor modulator,1,2 is a medication [with a mechanism of action] that affects nerves by causing a depletion of neurotransmitters, thus making the nerve less able to transmit pain.25,26 PHN of the [TN] is a chronic condition characterized by extreme pain following herpes zoster infection, (commonly called shingles,) in the areas of the face and scalp which are innervated by the [TN].3,4,5 The [TN] also has superficial nerve endings in the nasal mucosa, which are the targets of Civamide Nasal Spray. By affecting these nerve endings the entire nerve's ability to transmit pain is reduced. This novel mechanism of action has been observed when Civamide Nasal Spray is applied to the nasal mucosa in subjects with headache disorders mediated by the [TN], e.g. migraine headaches and cluster headaches with resulting decreases in headache pain and frequency. This study is a 9 week, double-blind, vehicle-controlled study of adult subjects that have moderate to severe pain (a minimum of an average pain score of 4 on a 0-10 point scale) due to PHN of the [TN] for at least 12 months. The study is composed of a 1-week non-treatment Baseline Period during which subjects will be required to complete a daily diary assessing overall pain and sleep interference. The 1 week Baseline Period will be followed by a 6 week Double-Blind Treatment Period and a 2 week Observation Period. Subjects will be randomized 1:1, approximately [20] subjects per group. The primary outcome variable will be the change in the Average Daily PHN Pain Score from the Baseline Period to the last week of the Treatment Period. Adverse events will be recorded during the study.

描述（由申请人提供）：该项目是对三叉神经的后脑膜神经痛（PHN）的概念临床研究的初步证明[（TN），一种严重禁用的面部疼痛综合征]。 Civamide鼻喷雾剂作为[TN]的PHN的治疗方法，以前已被授予孤儿药物。如果这项研究在[TN]的PHN治疗方面取得了成功，则将进行进一步的临床发育，即2阶段和第3阶段研究，以支持提交新药物的应用。目前，所有用于治疗[TN] PHN的药物都是系统地作用的药物。 civamide鼻喷雾的独特之处在于它在没有全身吸收的情况下施加其治疗作用[在药代动力学研究中被检测到的。8]可用于这些患者的安全有效药物，即这些患者的PHN，即，即civemide nasal Spray将填充无效的医疗医疗药物。 需要。 civamide是一种TRPV-1受体调节剂，1,2是一种药物（具有一种作用机制），通过导致神经递质的耗竭来影响神经，因此使神经较低的能力降低了[TN]的25,26 PHN。 [TN]的支配。3,4,5[TN]在鼻粘膜中也具有浅表神经末端，这是Civamide鼻喷雾的靶标。通过影响这些神经末端，整个神经传递疼痛的能力会降低。当在[TN]介导的头痛障碍受试者中，将Civamide鼻鼻施应用到鼻粘膜时，已经观察到了这种新颖的作用机理。偏头痛和簇头痛，导致头痛疼痛和频率减轻。这项研究是一项为期9周的双盲，车辆控制的研究，对成年受试者，由于[TN]的PHN至少12个月，因此患有中度至重度疼痛的成年受试者（在0-10点尺度上的平均疼痛评分为4）。该研究由1周的非治疗基线期组成，在此期间，将需要受试者完成每天评估整体疼痛和睡眠干扰的日记。 1周的基线期将是一个为期6周的双盲治疗期和2周的观察期。受试者将被随机分别为1：1，每组大约[20]受试者。主要结果变量将是从基线期到治疗期的最后一周的平均每日PHN疼痛评分的变化。在研究期间将记录不良事件。