An Open-Label, Multicenter Study to Evaluate the Safety and Efficacy of Repeat Intramuscular ABP-450 (prabotulinumtoxinA) Injection for the Treatment of Cervical Dystonia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 20
- 主要终点
- Number of Participants With Treatment-related Serious Adverse Events
研究概览
简要总结
This Open-label Extension trial will evaluate the safety and efficacy of ABP-450 for the treatment of cervical dystonia in adults. The study will enroll 60 patients across approximately 42 sites in the United States from Phase 2 (ABP-19000) trial. Study subjects who had their initial dose of study drug in the Phase 2 trial, irrespective of treatment allocation, will be eligible to enroll in this OLE study.
详细描述
This Open-label Extension trial will evaluate the safety and efficacy of ABP-450 for the treatment of cervical dystonia in adults. The study will enroll 60 patients across approximately 42 sites in the United States from Phase 2 (ABP-19000) trial. Study subjects who had their initial dose of study drug in the Phase 2 trial, irrespective of treatment allocation, will be eligible to enroll in this OLE study. Study subjects will receive a predetermined dose of ABP-450 between the Low Dose and High Dose, based on the investigator's discretion and clinical judgment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Qualified for and had their initial dose of study drug in the ABP-19000 study.
- •Provided written informed consent to being treated for cervical dystonia with ABP-
- •Were a male or female patient between 18 and 75 years of age (inclusive) when they entered the ABP-19000 study.
- •Stated willingness to comply with all study procedures, including attendance at the study center for all study visits as scheduled and have technological capabilities to have tele visits.
排除标准
- •Participated in another interventional study during participation in this study.
- •Were a pregnant or lactating female, or female of child-bearing potential not willing to use an acceptable method of contraception (ie, intrauterine device, barrier methods with spermicide, or abstinence).
- •Would not benefit from treatment with ABP-450 for their cervical dystonia, in the investigator's opinion.
- •Viral or other active infection or any medical condition that, in the opinion of the investigator, classifies the patient as unsuitable for participation in the study or patients who do not seem to be in good general health at the time of Day 0 "rollover", and prior to any investigational study drug administration.
研究组 & 干预措施
ABP-450 - Between Low Dose and High Dose
ABP-450 Between Low Dose and High Dose - Intramuscular injections into affected neck muscles with investigator's determined dose within the range of low dose and high dose - 4 injection cycles at 3-month intervals.
干预措施: ABP-450 (Drug)
结局指标
主要结局
Number of Participants With Treatment-related Serious Adverse Events
时间窗: Up to 52 weeks
The primary safety endpoint will be the incidence of treatment-related serious adverse events since the start of treatment by Treatment Group when dosed with ABP-450 between Low Dose and High Dose.
次要结局
- Mean Change in Patient Global Impression of Change (PGI-C)(Four weeks after the dose of each cycle (4 cycles))
- Mean Change in the Subscale Score of Disability of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Spasmodic Torticollis Rating Scale (TWSTRS)(Four weeks after the dose of each cycle (4 cycles))
- Mean Change in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score(Four weeks after the dose of each cycle (4 cycles))
- Mean Change in the Subscale Score of Pain of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)(Four weeks after the dose of each cycle (4 cycles))
- Mean Change in Clinical Global Impression of Change (CGI-C)(Four weeks after the dose of each cycle (4 cycles))
- Mean Change in the Subscale Score of Severity of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)(Four weeks after the dose of each cycle (4 cycles))