EUCTR2011-004980-63-PL进行中（未招募）不适用
BOTOX® Treatment in Adult Patients with Post-Stroke Lower Limb Spasticity - NA
Allergan Ltd.0 个研究点目标入组 418 人开始时间: 2012年7月26日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 418
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. male or female, =18 to = 85 years of age at the screening visit
- •2. patients who are diagnosed with post-stroke lower limb spasticity present with equinus (plantar flexion of the ankle) or equinovarus deformity, with the most recent stroke occurring at least 3 months prior to the screening visit
- •3. a minimum body weight of 50 kg at the screening visit
- •4. written informed consent has been obtained
- •5. written documentation has been obtained in accordance with the
- •relevant country and local privacy requirements, where applicable (e.g. Written Authorization for Use and Release of Health and Research Study Information (United States (US) sites) and written Data Protection consent (European Union (EU) sites).
- •6. MAS-B score of = 3 in the ankle plantar flexors at both screening and day 1 visits
- •7. botulinum toxin treatment-naïve or if previously treated with
- •botulinum toxin of any serotype:
- •- = 20 weeks prior to the day 1 visit if treated for spasticity of the study limb, or
- •- = 12 weeks prior to the day 1 visit if treated for an indication other than spasticity of the study limb
- •8. acceptable clinical laboratory results at screening at the investigator's discretion
- •9. for females of childbearing potential, a negative urine pregnancy test at screening and on the day 1 visit
- •10. patients who are on spasmolytic medications or muscle relaxants (eg, oral baclofen, tizanidine, dantrolene, scopolamine [oral or patch], vigabatrin, or benzodiazepine therapy) must be on a stable dose and regimen for at least 2 months prior to the day 1 visit
- •11. patients who are on anti-epileptic medications must be on a stable dose and regimen for at least 1 month prior to the day 1 visit
- •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 222
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 196
排除标准
- •1. patients with spasticity in the contralateral leg that requires
- •2. presence of fixed contractures of the ankle (absence of range of
- •motion) in the study leg
- •3. profound atrophy of the muscles to be injected at the investigator's discretion
- •4. previous surgical intervention, phenol block, ethanol block, or muscle afferent block:
- •a) prior to screening for the treatment of spasticity in the study limb for muscles eligible for double-blind treatment, or
- •b) within 6 months prior to screening for any other muscles in the upper or lower limbs
- •5. casting of the study limb within 6 months prior to the screening visit and/or plans to cast the study limb during the double-blind phase of the study
- •6. treatment modalities in the study limb, including ultrasound therapy, transcutaneous electrical nerve stimulation, electrical stimulation, or acupuncture within 1 month of the day 1 visit or planned during the double-blind phase of the study
- •7. etiology other than stroke contributing to lower limb spasticity (eg, multiple sclerosis, traumatic brain injury, spinal cord injury)
- •8. infection of local skin, soft tissue, and joint in the areas to be injected or patients at a high risk of infection (eg, under immunosuppression treatments)
- •9. history of severe, progressive, or current unstable medical conditions as determined by medical history, physical examination and/or laboratory tests
- •10. patients with presence or history of aspiration pneumonia, recurrent lower respiratory tract infections, or compromised respiratory function per investigator's clinical judgment
- •11. patients with an active malignancy of any type or a history of
- •malignancy within the last 5 years (except basal cell carcinoma of the skin or squamous cell carcinoma of the skin with clean margins that has been excised at least 12 weeks prior to screening)
- •12. history of substance abuse or dependence within 12 months prior to the screening visit, excluding nicotine and caffeine
- •13. known allergy or sensitivity to the study medication(s) or its
- •14. nonambulatory patients defined as patients not able to perform the
- •10 meter walking test independently with or without assistive device
- •15. females who are pregnant, nursing, or planning a pregnancy during the study period
- •16. females of childbearing potential, not using a reliable means of
- •contraception [See protocol Section 4.5.1.1 for definition of acceptable methods of contraception]
- •17. current enrollment in an investigational drug, nonpharmacological treatment or interventional device study or participation in such a study within 30 days prior to the screening visit
- •18. any medical or neurological condition that may put the patient at increased risk with exposure to BOTOX, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other significant diseases or concomitant medications that might interfere with neuromuscular function
- •19. Patient has a condition, is planning a surgery requiring general
- •anesthesia during the study, or is in a situation which in the
- •investigator's opinion may put the patient at significant risk, may
- •confound the study results, or may interfere significantly with the
- •patient's participation in the study.
- •20. Patients on intrathecal baclofen pump
- •21. Physical therapy (physiotherapy) or use of static or dynamic splints including dynamic ankle foot orthosis (AFO), in the study limb that is initiated less than 14 days pri
研究者
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