A Phase 2, Randomized, Double-Blind, Multicenter, Placebo Controlled Study to Evaluate the Safety and Efficacy of 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
- 61
- 试验地点
- 21
- 主要终点
- Number of Participants With Treatment-Related Serious Adverse Events
研究概览
简要总结
This Phase 2 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 30 sites in the United States. Study subjects will be divided evenly across a low dose group, a medium dose group, a high dose group, and a placebo group for one treatment cycle.
详细描述
This Phase 2 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 30 sites in the United States. Study subjects will be divided evenly across a low dose, a medium dose group, a high dose and placebo group for one treatment cycle.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The investigator, study nurse/other study personnel, and patients will be blinded to the treatment group. An appropriately trained person will reconstitute investigational product, fill masked syringes and provide them to the blinded investigator, but will not perform any assessments with the patient.
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
- •Male or female patients between 18 and 75 years of age (inclusive)
- •A clinical diagnosis of cervical dystonia (ie, spasmodic torticollis) defined by:
- •TWSTRS total score ≥20
- •TWSTRS severity score ≥10
- •TWSTRS disability score ≥3
- •TWSTRS pain score ≥1
- •On a stable dose of medications (if any) used for focal dystonia treatment (eg, anticholinergics and benzodiazepines) for at least 3 months prior to and expected throughout the study duration
- •For pre-treated patients only: Source documentation (eg, patient history) of the last 2 consecutive injection sessions with a botulinum toxin type A
- •For pre-treated patients only: At least 16 weeks must have passed between the last injection with botulinum toxin for cervical dystonia and baseline treatment (patients can be screened at Week 15 but cannot be enrolled until 16 weeks [for Day 0 injection])
- •Provided written informed consent to being treated for cervical dystonia with ABP-450
- •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 televisits
排除标准
- •Traumatic torticollis or tardive torticollis
- •Predominant retrocollis or anterocollis
- •Myotomy or denervation surgery in the affected muscles (eg, peripheral denervation and/or spinal cord stimulation)
- •Hypersensitivity to human serum albumin, sucrose, or botulinum toxin type A
- •Previous treatment for cervical dystonia with rimabotulinumtoxin B
- •Diagnosis of myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, or any other significant neuromuscular disease that might interfere with the trial
- •Current swallowing disorder of any origin (dysphagia scale ≥3, ie, severe, with swallowing difficulties and requiring a change in diet)
- •Marked limitation on passive range of motion that suggests contractures or other structural abnormality, eg, cervical contractures or cervical spine syndrome
- •Treatment with botulinum toxins of any type for any indication other than cervical dystonia within 16 weeks prior to baseline and during the study
- •Medical or psychiatric conditions that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study
- •Participation in another interventional study during participation in this study
- •Pregnant or lactating females, or females of child-bearing potential not willing to use an acceptable method of contraception (ie, intrauterine device, barrier methods with spermicide, or abstinence)
- •For pre-treated patients only: The patient's most recent injection with botulinum toxin exceeding the number of units specified as follows:
- •OnabotulinumtoxinA (BOTOX®): >300 units
- •IncobotulinumtoxinA (Xeomin®): >300 units
- •AbobotulinumtoxinA (Dysport®): >750 units
研究组 & 干预措施
ABP-450 - Low Dose
ABP-450 Low Dose - Intramuscular injections into affected neck muscles.
干预措施: ABP-450 (Drug)
ABP-450 - Medium Dose
ABP-450 Mid Dose - Intramuscular injections into affected neck muscles.
干预措施: ABP-450 (Drug)
ABP-450 - High Dose
ABP-450 High Dose - Intramuscular injections into affected neck muscles.
干预措施: ABP-450 (Drug)
Placebo
Placebo (0.9% saline, sterile, unpreserved, USP/Ph.Eur.) - Intramuscular injections into affected neck muscles.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With Treatment-Related Serious Adverse Events
时间窗: Baseline up to 20 Weeks
The primary safety endpoint will be the number of participants with treatment-related serious adverse events since the start of treatment by Treatment Group when dosed with placebo, ABP-450 (low dose), ABP-450 (medium d dose), or ABP-450 (high dose).
次要结局
- Mean Change in Clinical Global Impression of Change (CGI-C) From Baseline to Week 4(Baseline to Week 4)
- Mean Change of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)-Total Score From Baseline to Week 4(Baseline to Week 4)
- Mean Change in the Subscale Score of Disability of the Baseline Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) From Baseline to Week 4(Baseline to Week 4)
- Mean Change in the Subscale Score of Severity of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) From Baseline to Week 4(Baseline to Week 4)
- Mean Change in Patient Global Impression of Change (PGI-C) From Baseline to Week 4(Baseline to Week 4)
- Mean Change in the Subscale Score of Pain of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) From Baseline to Week 4(Baseline to Week 4)