EUCTR2018-000447-11-GB进行中（未招募）1 期
A Phase 3, Open-Label, Multi-Center Trial to Evaluate the Long-Term Safety and Efficacy of Repeat Treatments of DaxibotulinumtoxinA for Injection in Adults with Isolated Cervical Dystonia (ASPEN-OLS) - ASPEN-OLS
Revance Therapeutics Inc0 个研究点目标入组 350 人开始时间: 2018年10月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 350
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1. Adults, 18 to 80 years of age
- •2. Meets diagnostic criteria for isolated CD (idiopathic; dystonic symptoms localized to the head, neck, shoulder areas) with at least moderate severity at Baseline (Day 1), defined as a TWSTRS-total score of at least 20, with at least 15 on the TWSTRS-Severity subscale, at least 3 on the TWSTRS-Disability subscale, and at least 1 on the TWSTRS-Pain subscale (minimum TWSTRS subscale criteria applicable only to subjects not previously enrolled in Study Protocol 1720302)
- •3. Subjects who were previously enrolled in Study Protocol 1720302, who completed the study, including:
- •a) Those with no reduction or have an increase from baseline in the average TWSTRS-total score at Weeks 4 and 6 (i.e., improvement or worsened disease status), and the investigator agreed that there was a need for retreatment based on the subject’s symptoms and neurologic examination findings
- •b) Those who benefited from study treatment and complete follow-up study visits up to the time point of when their TWSTRS-total score reached/exceeded their target TWSTRS score
- •c) Those who benefit from study treatment but subsequently experienced significant recurrence of CD symptoms (e.g., pain) during the study before their TWSTRS-total score reached their target TWSTRS score and requested retreatment, which the investigator determined was warranted due
- •based on the subject’s symptoms and neurologic examination findings
- •d) Those who completed study visits up to Week 36 and their TWSTRS-total score never reached their target TWSTRS score and they never requested another treatment. The investigator determined that these subjects can be followed in the OLS until their TWSTRS-total score is the same or higher than their target TWSTRS score or until they request retreatment, which the investigator determined is clinically indicated
- •4. De novo subjects (not previously enrolled in Study Protocol 1720302):
- •a) Naïve to BoNT treatment
- •b) BoNT treatment-experienced; if previously treated with BoNTA, the subject must have demonstrated a clinically meaningful response to the last BoNTA treatment based on the clinical judgment of the investigator
- •5. Written informed consent including authorization to release health information
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 245
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 105
排除标准
- •1. Cervical dystonia attributable to an underlying etiology, (e.g., traumatic torticollis or tardive torticollis)
- •2. Predominant retrocollis or anterocollis CD
- •3. Significant dystonia in other body areas, or is currently being treated with BoNT for dystonia in areas other than those associated with isolated CD
- •4. Severe dysphagia (Grade 3 or 4 on the Dysphagia Severity Scale) at Screening or Baseline (prior to study treatment)
- •5. Any neuromuscular neurological conditions that may place the subject at increased risk of morbidity with exposure to BoNT, including peripheral motor neuropathic diseases (e.g., amyotrophic lateral sclerosis and motor neuropathy, and neuromuscular junctional disorders such as Lambert-Eaton syndrome and myasthenia gravis)
- •6. Previous treatment with any BoNT product, except investigational daxibotulinumtoxinA, for any condition within the 16 weeks prior to Screening (applicable only to de novo subjects)
- •7. Botulinum neurotoxin treatment-experienced subjects who have historically required <100 U of Botox or its equivalent to effectively treat their CD symptom (applicable only to de novo subjects)
- •8. Botulinum neurotoxin treatment-experienced subjects who had suboptimal or no treatment response to the most recent BoNTA injection for CD, as determined by the investigator, or history of primary or secondary non-response to BoNTA injections, known to have neutralizing antibodies to BoNTA, or have a history of botulinum toxin type B (rimabotulinumtoxinB [Myobloc/Neurobloc]) injection for CD due to nonresponse or suboptimal response to BoNTA (applicable only to de novo subjects)
- •9. Use of deep brain stimulation, or intrathecal baclofen for dystonia
- •10. Subjects on oral medications for focal dystonia (e.g., anticholinergics, muscle relaxants, benzodiazepines, dopamine depleter) or neuroleptics for psychiatric conditions (e.g., risperidone, olanzapine, clozapine, quetiapine), who have not been stable on their regimen for at least 4 weeks prior to Screening
- •11. Neurological abnormalities in the neck other than CD
- •12. Previous neck surgery, phenol injection to the neck muscles, myotomy or denervation surgery in the neck/shoulder region (e.g., peripheral denervation, spinal cord stimulation)
- •13. Profound atrophy of cervical musculature, or cervical contractures or cervical spinal deformity leading to marked limitation on passive range of motion
- •14. Use of aminoglycoside antibiotics, polymyxins, lincosamides (e.g., clindamycin), or other agents that might interfere with neuromuscular transmission (e.g., curare-like drugs, quinidine, magnesium sulfate, anticholinesterases, succinylcholine chloride) within 14 days prior to Screening
- •15. Women of child bearing potential (WOCBP), who have a positive pregnancy test at Screening, or do not agree to use an effective method of birth control during the course of the study
- •16. Female, who is pregnant or nursing (lactating)
- •17. Screening 12-lead ECG with exclusionary conduction criteria of corrected QT interval (using Fridericia's correction formula): QTcF interval > 450 msec (males) or > 470 msec (females), heart block (i.e., second degree AV block Mobitz Type 2, third degree AV block or complete heart block), or ven
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