NCT00549341已完成1 期
A Phase I, Single-dose, Double-blind, Placebo Controlled, Dose Escalation Study to Evaluate the Safety of PurTox for the Treatment of Adult Onset Spasmodic Torticollis/Cervical Dystonia and to Explore Dose-associated Efficacy
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Absence of significant drug related adverse effects
研究概览
简要总结
The safety and efficacy of Mentor Purified Toxin, Botulinum Toxin Type A, Purified Neurotoxin, injected intramuscularly into the neck, is being evaluated as a treatment for painful and non-painful spasmodic torticollis/cervical dystonia. It is hypothesized that treatment will decrease symptom severity and will not have any significant side effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of torticollis with noticeable symptoms for at least 6 months
- •Total TWSTRS score greater or equal to 20, TWSTRS severity score greater than or equal to 10 and TWSTRS Disability score greater than or equal to 3 (must meet all 3 criteria)
排除标准
- •Diagnosis of isolated anterocollis
- •Concurrent myopathic disease, myotonic dystrophy (or other form of muscular dystrophy), myasthenia gravis
- •Currently receiving aminoglycoside antibiotic therapy, curare-like drugs, quinidine, succinylcholine, polymixins, anticholinesterases, magnesium sulfate, or lincosamides
- •Any illness that is considered by the Investigator to make the subject an inappropriate candidate
- •Cervical spine injury within 18 months or head and neck surgery within 6 months prior to screening
- •Pre-existing dysphagia
- •History of active autoimmune disease
- •Exposure to botulinum toxin based pharmaceutical within 3 months prior to screening
- •History of primary non-response or secondary resistance with prior exposure to botulinum based pharmaceuticals
- •History of chemotherapy/radiation for malignant disease within 24 months
- •Any investigational drug/device during the 30 days prior to screening
研究组 & 干预措施
1
Active Comparator
干预措施: Mentor Purified Toxin, Botulinum Toxn Type A, Purified Neurotoxin (Drug)
2
Placebo Comparator
干预措施: Physiologic saline (Other)
结局指标
主要结局
Absence of significant drug related adverse effects
时间窗: Post-injection
次要结局
- Decrease in symptom severity (TWSTRS)(30 days post-injection)
研究者
研究点 (1)
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