EUCTR2019-003647-29-PL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, LLC, a subsidiary of MDD US Operations, LLC0 个研究点目标入组 272 人开始时间: 2020年3月2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, traumatic brain injury (TBI) or spinal cord injury that occurred =6 months prior to randomization. Eligible subjects may have lower limb monoplegia or hemiplegia. Subjects with cerebral palsy are eligible for study enrollment.
- •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 or any type of seizure disorder with a seizure(s)
- •within the previous year.
- •3. Neuromuscular disorders including, but not limited to, amyotrophic
- •lateral sclerosis, primary lateral sclerosis, multiple sclerosis, 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 affected lower limb.
- •5. Unresolved fracture(s) in the affected lower limb.
- •6. Severe atrophy in the affected lower limb.
- •7. Known hypersensitivity to BoNT/ A or BoNT/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
- •affected lower limb 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.
- •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.
- •14. Prior BoNT/A or BoNT/B treatment in the affected lower limb within
- •24 weeks before screening. Prior BoNT/A or BoNT/B treatment in areas
- •other than the affected lower limb is not exclusionary but must have
- •occurred at least 12 weeks before screening. Prior toxin exposure must
- •have been well tolerated & without any significant long-term side effects
- •in case of repeated prior exposure.
- •15. Subjects should not receive nor have any plans to receive any
- •botulinum toxin treatment, other than study drug (MYOBLOC), from the
- •point informed consent is obtained until study participation is complete
- •16. Severe dysphagia (i.e. inability to swallow liquids, solids/both
- •without choking/medical intervention) or dysphagia with a history of
- •aspiration pneumonia within 6 months before screening
- •17. Prior surgery to treat spasticity in the affected lower limb (i.e tendon lengthening or tendon transfer).
- •18. Any anticipated/scheduled surgery during study period with
- •exception of dermatological procedures performed under local
- •anesthesia for purposes of removing precancerous and cancerous
- •19. Major surgery within 3 months before screening.
- •20. Pregnancy/breastfeeding.
- •21. Females of childbearing potential must agree to use a medically
- •acceptable method of contraception (e.g., intrauterine device, hormonal
- 另有 5 项未显示
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