Prospective, Open-label Clinical Study of Ingrezza (Valbenazine) for the Treatment of Cervical Dystonia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in incidence of pain/spasm
研究概览
简要总结
Study of Ingrezza (Valbenazine) for the treatment of cervical dystonia.
详细描述
The study will be an open-label, prospective study. Patients with a diagnosis of cervical dystonia will undergo 4 weeks of baseline evaluation, followed by a 12-week treatment period. Subjects will be evaluated in-clinic every 4 weeks. Standardized assessments will be performed at these visits. Data will also be collected from wearable IMUs (inertial measurement units) and analyzed for improvements in involuntary, repetitive movements and postures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female patients between 18 and 85 years of age (inclusive)
- •A clinical diagnosis of cervical dystonia (ie, spasmodic torticollis) by investigator for at least six months
- •Moderate to severe head tremor and/or dystonic posturing as judged by the investigator
- •Stable Botulinum Toxin (Botox, Dysport, Xeomin, or Myobloc) therapy dosage for at least 3 months prior to baseline visit
- •Exclusion Criteria
- •Tardive dyskinesia
- •Predominant anterocollis
- •Concomitant use of strong CYP3A4 inhibitors (i.e. itraconazole, ketoconazole, clarithromycin), digoxin, strong CYP2D6 inhibitors (i.e. paroxetine, fluoxetine, quinidine), monoamine oxidase inhibitors (i.e. isocarboxazid, phenelzine, selegiline)
- •Myotomy or denervation surgery in the affected muscles (eg, peripheral denervation and/or spinal cord stimulation)
- •Diagnosis of Myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, or any other significant neuromuscular disease which might interfere with the trial
- •Moderate to severe hepatic impartment as determined by a Child-Hugh Score ≥7
- •Marked limitation on passive range of motion that suggests contractures or other structural abnormality, eg, cervical contractures or cervical spine syndrome
- •Any 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
- •History of hypersensitivity to valbenazine or any components of INGREZZA.
- •Is suicidal at screening as defined by below:
- •According to the C-SSRS, he or she must not be actively suicidal at Visit 1 (Screening) or Visit 2 (Baseline) (including, an answer of "yes" to C-SSRS questions 4 or 5 [current or over the last 6 months]) and must not have attempted suicide in the 1 year prior to Visit 1 (Screening); OR
- •The subject is actively suicidal in the Investigator's judgment
排除标准
- 未提供
研究组 & 干预措施
Ingrezza
Participants will receive Ingrezza orally once daily for 12 weeks.
干预措施: Ingrezza Pill (Drug)
结局指标
主要结局
Change in incidence of pain/spasm
时间窗: 16 weeks
Change in incidence rate of pain/spasm as measured by frequency and intensity in subjects prior to and during use of valbenazine as measured by Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) and Inertial measurement unit (IMU). TWSTRS is a composite scale used to measure three aspects of CD: severity, disability, and pain. TWSTRS total score falls within the range of 0 to 85, where a higher score indicates a more severe condition.
次要结局
未报告次要终点