NCT02706795已完成2 期
Dose-escalating Safety and Preliminary Efficacy of DaxibotulinumtoxinA for Injection in Cervical Dystonia
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 26
- 主要终点
- Improvement of dystonia as measured by change from baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) - Total Score
研究概览
简要总结
This is an open-label, dose-escalation study to assess the safety and preliminary efficacy of daxibotulinumtoxinA in subjects with isolated cervical dystonia (CD).
研究设计
- 研究类型
- Interventional
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
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
- •Meets diagnostic criteria for isolated cervical dystonia
- •Has moderate severity with a baseline Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) - Total score of at least 20 and a TWSTRS-Severity subscale score or at least 15
- •Has been using stable doses of focal dystonia medications for at least 3 months and willing to continue through end of study
排除标准
- •Cervical dystonia attributable to an underlying etiology, such as traumatic torticollis or tardive torticollis; predominant retrocollis or anterocollis cervical dystonia
- •Significant dystonia in other body areas, or is currently being treated with botulinum toxin for dystonia in other areas than isolated cervical dystonia
- •Neurological abnormalities other than cervical dystonia
- •History of severe dysphagia or aspiration, or current clinically significant swallowing disorder
- •Previous neck surgery, phenol injection to the neck muscles, myotomy or denervation surgery in the neck/shoulder region, or intrathecal baclofen
- •Marked limitation on passive range of motion that suggests contractures or other structural abnormality, e.g. cervical contractures or cervical spinal deformity
- •Profound atrophy of cervical musculature
- •Any neurological condition that may place the subject at increased risk with exposure to botulinum toxin type A, including peripheral motor neuropathic diseases such as amyotrophic lateral sclerosis and motor neuropathy, and neuromuscular junctional disorders such as Lambert-Eaton syndrome and myasthenia gravis
- •Suboptimal efficacy response to any prior botulinum toxin type A product, when a previous treatment produced more optimal therapeutic response, as judged subjectively by the Investigator
- •Previous treatment with any botulinum toxin product for any condition within the 6 months prior to Screening and during the study; presence of any blood coagulation disorder; or on anticoagulation treatment with international normalized ratio (INR) > 3.5
结局指标
主要结局
Improvement of dystonia as measured by change from baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) - Total Score
时间窗: Week 4
次要结局
- Change from baseline in TWSTRS subscale scores (Severity, Disability and Pain)(Post-treatment: Weeks 2, 4, 6, 9, 12, 16, 20, 24)
- Duration of effect based on number of weeks from treatment until return of symptoms that warrant treatment(Post-treatment: Weeks 2, 4, 6, 9, 12, 16, 20, 24)
- Percentage of responders showing improvement on Clinical Global Impression of Change (CGIC)(Post-treatment: Weeks 2, 4, 6, 9, 12, 16, 20, 24)
- Change from baseline in Toronto Western Spasmodic Torticollis Rating Scale(TWSTRS) - Total Score(Post-treatment: Weeks 2, 4, 6, 9, 12, 16, 20, 24)
- Percentage of treatment responders with at least a 20% reduction in the TWSTRS - Total score post-treatment(Weeks 2, 4, 6, 9, 12, 16, 20, 24)
- Patient-rated quality of life measurement based upon change from baseline of the Cervical Dystonia Impact Profile Scale (CDIP-58)(Post-treatment: Weeks 4, 6, 12, 16, 20, 24)
研究者
研究点 (26)
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