EUCTR2019-003647-29-HU进行中（未招募）1 期
A Phase 2/3, Multicenter, Randomized, Double-Blind, Placebo Controlled, Single-Treatment Efficacy and Safety Study of MYOBLOC® in the Treatment of Adult Lower Limb Spasticity Followed by an Open-Label Extension, Multiple-Treatment Safety Study of MYOBLOC
Solstice Neurosciences a wholly-owned subsidiary of US WorldMeds, LLC0 个研究点目标入组 272 人开始时间: 2020年1月21日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 272
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
- 性别
- All
入选标准
- •1. Able to understand the potential risks and benefits, the study requirements, and provide written informed consent before enrollment into the study; if unable, the subject’s Legally Authorized Representative (LAR) may provide written informed consent.
- •2. Male or female =18 to maximum of 80 years of age, inclusive.
- •3. Lower limb spasticity due to stroke or TBI that occurred =6 months prior to randomization. Eligible subjects may have lower limb monoplegia or hemiplegia.
- •4. Ambulatory (with or without the use of a walking assistive device).
- •5. Modified Ashworth Scale (MAS) score =2 in the ankle plantar flexors of the affected lower limb at screening and at baseline.
- •6. In the Investigator’s opinion, the subject will be available and able to comply with the study requirements for at least 1 year, based on the subject’s overall health and disease prognosis.
- •7. In the Investigator’s opinion, the subject will be willing and able to comply with all requirements of the protocol, including completion of study questionnaires. A caregiver may be designated to assist with the physical completion of questionnaires/scales.
- •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 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 232
排除标准
- •1. Quadriplegia/tetraplegia, lower limb diplegia or triplegia.
- •2. Uncontrolled epilepsy with a seizure(s) within the previous year.
- •3. Neuromuscular disorders including, but not limited to, amyotrophic lateral sclerosis (ALS), primary lateral sclerosis (PLS), multiple sclerosis (MS), myasthenia gravis, or muscular dystrophy.
- •4. History of major joint contracture(s), in which, based on Investigator assessment, the contracture(s) significantly contribute to joint immobility in the target limb.
- •5. Unresolved fracture(s) in the lower limb identified for treatment.
- •6. Severe atrophy in the lower limb identified for treatment.
- •7. Known hypersensitivity to botulinum toxins type A or B or to any MYOBLOC solution components.
- •8. Concomitant use or exposure within 5 half-lives of randomization of the following: aminoglycoside antibiotics, curare-like agents, or other agents that may interfere with neuromuscular function.
- •9. Treatment with a neurolytic agent (e.g., phenol, alcohol blocks) to the lower limb identified for treatment within 1 year before randomization.
- •10. Presence of a spinal stimulator or intrathecal baclofen pump that has not been turned off within 30 days before screening.
- •11. Changes to treatment regimen or any new treatment with oral antispasmodics and/or muscle relaxants within 30 days before randomization.
- •12. Initiation of physical and/or occupational therapy <30 days before randomization. Subjects receiving physical and/or occupational therapy >30 days before randomization must be willing to maintain their therapy regimen through Week 4 of the DBP of the study.
- •13. Application of an ankle-foot orthosis (AFO) <30 days before randomization. Subjects regularly using an AFO >30 days before randomization must be willing to maintain use of the AFO through Week 4 of the DBP of the study.
- •14. Prior botulinum toxin typeA (BoNT/A) or B (BoNT/B) treatment in the lower limb identified for treatment within 24 weeks before screening. Prior BoNT/A or BoNT/B treatment in areas other than the lower limb identified for treatment is not exclusionary but must have occurred at least 12 weeks before screening. Prior toxin exposure must have been well tolerated and without any significant long-term side effects in the case of repeated prior exposure.
- •15. Subjects should not receive nor have any plans for receiving any botulinum toxin treatment, other than the study drug (MYOBLOC), from the point informed consent is obtained until participation is complete.
- •16. Severe dysphagia (i.e., inability to swallow liquids, solids or both without choking or medical intervention), or dysphagia with a history of aspiration pneumonia, within 6 months before screening.
- •17. Prior surgery to treat spasticity in the lower limb selected for treatment (i.e., tendon lengthening or tendon transfer).
- •18. Any anticipated or scheduled surgery during the study period, with the exception of dermatological procedures performed under local anesthesia for the purposes of removing precancerous and cancerous lesions.
- •19. Major surgery within 30 days before screening.
- •20. Pregnancy or breastfeeding.
- •21. Females of childbearing potential must agree to practice a medically acceptable method of contraception (e.g., intrauterine device, hormonal contraception started at least one full cycle before study enrollment or barrier method in conjunction with spermicide) for the duration of the study (including 2 months after study completion). For the purposes of this study, all females ar
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