CLINICAL TRIAL: PROSPECTIVE, DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED, MULTI

临床试验：前瞻性、双盲、安慰剂对照、随机、多项

• 批准号: 7725037
• 负责人: Neal Hermanowicz
• 金额: $ 0.05万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN DIEGO
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-12-01 至 2008-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7725037
• 关键词: Affect; Allergic Reaction; Antibody Formation; Bontoxilysin; Botox; Botulinum Toxin Type A; Botulinum Toxins; Cervical Dystonia; Clinical Trials; Complex; Computer Retrieval of Information on Scientific Projects Database; Double-Blind Method; Drug Formulations; Effectiveness; Elan brand of botulinum toxin type B; Funding; Grant; Institution; Investigational Drugs; Lead; Names; Neurotoxins; Placebo Control; Placebos; Proteins; Purpose; Randomized; Research; Research Personnel; Resistance; Resources; Safety; Skeletal muscle structure of neck; Source; Spasm; Symptoms; Thinking; Time; United States Food and Drug Administration; United States National Institutes of Health; botulinum toxin type B; manufacturing process; prospective; research study; response

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The purpose of this research study is to evaluate the safety and effectiveness of a newly developed investigational formulation of Botulinum Neurotoxin, NT 201, a highly purified form of Botulinum Neurotoxin as compared with placebo (an inactive substance) in subjects with cervical dystonia. Cervical dystonia symptoms are caused by involuntary activity of the muscles of the neck which may lead to permanent spasm in the regions affected. Two Botulinum Toxins are currently approved by the FDA under the brand names Botox (Botulinum Toxin type A) and Myobloc (Botulinum Toxin type B) for the treatment of cervical dystonia. Unfortunately, after a time, between 3% and 10% of subjects treated no longer respond to the commercially available products containing Botulinum Toxin. It is suspected that the fairly large quantities of other ingredients (complex proteins) also present in these products may cause the body's defenses to react. As a result, the active substance becomes inactive by the formation of antibodies (proteins created by the body in response to a foreign substance). Allergic reactions may also occur. For these reasons, a special manufacturing process has been used to develop a new investigational drug containing only traces of the accompanying proteins that are thought to inactivate the neurotoxin or cause resistance to develop.

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这不一定是调查员的机构。 这项研究的目的是评估肉毒神经毒素的新研究制定，NT 201，一种高度纯化的肉毒杆菌神经毒素形式，与安慰剂（一种非活性物质）相比，在宫颈肌张力障碍的受试者中相比。 宫颈肌张力障碍症状是由颈部肌肉的非自愿活动引起的，这可能导致受影响区域的永久痉挛。 目前，FDA批准了两种肉毒杆菌毒素，该品牌名称肉毒杆菌毒素（肉毒杆菌毒素A型）和肌无菌（Botulinum毒素B型）用于治疗宫颈肌张力障碍。 不幸的是，一段时间后，接受治疗的受试者中有3％至10％不再对含有肉毒杆菌毒素的市售产品反应。 怀疑这些产品中还存在相当大量的其他成分（复杂蛋白）可能导致人体的防御能力做出反应。 结果，活性物质通过抗体的形成（人体响应异物而产生的蛋白质）而变得无活跃。 也可能发生过敏反应。由于这些原因，已经使用特殊的制造过程来开发一种新的研究药物，该药物仅包含伴随蛋白质的痕迹，这些蛋白质被认为会使神经毒素失活或引起抗性。