NCT00432666已完成3 期
Prospective, Double-blind, Placebo-controlled, Randomized, Multi-center Trial With an Open-label Extension Period to Investigate the Efficacy and Safety of incobotulinumtoxinA (Xeomin) in the Treatment of Post-stroke Spasticity of the Upper Limb
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 148
- 主要终点
- Number of Participants With Reduction of at Least 1 Point at Week 4 Compared to Baseline in Ashworth Score in Wrist Flexors
研究概览
简要总结
IncobotulinumtoxinA (Xeomin) is a botulinum toxin type A preparation free from complexing proteins, i.e. free from proteins other than the active toxin. Injected into the muscle, incobotulinumtoxinA (Xeomin) causes local weakening. Botulinum toxin type A is widely used for treatment of various neurological conditions. This study will investigate the efficacy and safety of incobotulinumtoxinA (Xeomin) in the treatment of post-stroke spasticity of the upper limb.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female or male patients ≥ 18 years
- •≥ 6 months since the last stroke, diagnosed by an appropriate health care professional (e.g., neurologist)
- •Focal spasticity with ≥ 2 points on the Ashworth Scale in the wrist flexors with clinical pattern Flexed Wrist
- •Focal spasticity with ≥ 2 points on the Ashworth Scale in the fingers flexors with clinical pattern Clenched Fist
- •For pre-treated patients only: source documentation of the most recent injection session with Botulinum Toxin and sufficient therapeutic response for Flexed Wrist and Clenched Fist
- •For pre-treated patients only: the most recent injection with Botulinum Toxin must have been maximal 50 Units BOTOX® or 200 Units Dysport® or 2000 Units Neurobloc® (type B preparation) per each of these flexors: carpi ulnaris, digitorum superficialis, digitorum profundus
- •For pre-treated patients only: the most recent injection with Botulinum Toxin must have been maximal 60 Units BOTOX® or 240 Units Dysport® or 2400 Units Neurobloc® (type B preparation) for flexor carpi radialis
排除标准
- •Spasticity of any other origin than stroke
- •Previous treatment with Botulinum Toxin of any serotype and for any body region within the 4 months prior to Screening (Visit 1, Day -7)
- •Planned concomitant treatment with Botulinum Toxin of any serotype and for any body region
- •Previous or planned treatment with phenol- or alcohol-injection in the target limb
- •Previous surgical treatment of spasticity in the target muscle(s)
- •Fixed contracture, defined as severe restriction of the range of joint movement on passive stretch
- •Severe atrophy of the target limb muscles
研究组 & 干预措施
IncobotulinumtoxinA (Xeomin)
Experimental
incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), up to five injections in the Open-Label Extension Period, up to 400 units at each injection visit; Mode of administration: intramuscular injection
干预措施: IncobotulinumtoxinA (Xeomin) (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With Reduction of at Least 1 Point at Week 4 Compared to Baseline in Ashworth Score in Wrist Flexors
时间窗: Baseline, Week 4
The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.
次要结局
- Responders at Week 4 Based on a Responder Definition of at Least 2 Points Improvement From Baseline in the Ashworth Score for Wrist Flexors(Baseline, Week 4)
- Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Wrist Flexors at All Other Post Baseline Visits(Baseline, Week 2, Week 8, Week 12, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest))
- Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Elbow Flexors at All Post Baseline Visits(Baseline, Week 2, Week 4, Week 8, Week 12, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest))
- Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Forearm Pronators at All Post Baseline Visits(Baseline, Week 2, Week 4, Week 8, Week 12, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest))
- Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Finger Flexors at All Post Baseline Visits(Baseline, Week 2, Week 4, Week 8, Week 12, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest))
- Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Thumb Flexors at All Post Baseline Visits(Baseline, Week 2, Week 4, Week 8, Week 12, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest))
- Change From Baseline to Week 2 in Ashworth Scale Score for Treated Elbow Flexors(Baseline, Week 2)
- Change From Baseline to Week 4 in Ashworth Scale Score for Treated Elbow Flexors(Baseline, Week 4)
- Change From Baseline to Week 8 in Ashworth Scale Score for Treated Elbow Flexors(Baseline, Week 8)
- Change From Baseline to Week 12 in Ashworth Scale Score for Treated Elbow Flexors(Baseline, Week 12)
- Change From Baseline to Final Visit in Ashworth Scale Score for Treated Elbow Flexors(Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest))
- Change From Baseline to Week 2 in Ashworth Scale Score for Treated Forearm Pronators(Baseline, Week 2)
- Change From Baseline to Week 4 in Ashworth Scale Score for Treated Forearm Pronators(Baseline, Week 4)
- Change From Baseline to Week 8 in Ashworth Scale Score for Treated Forearm Pronators(Baseline, Week 8)
- Change From Baseline to Week 12 in Ashworth Scale Score for Treated Forearm Pronators(Baseline, Week 12)
- Change From Baseline to Final Visit in Ashworth Scale Score for Treated Forearm Pronators(Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest))
- Change From Baseline to Week 2 in Ashworth Scale Score for Wrist Flexors(Baseline, Week 2)
- Change From Baseline to Week 4 in Ashworth Scale Score for Wrist Flexors(Baseline, Week 4)
- Change From Baseline to Week 8 in Ashworth Scale Score for Wrist Flexors(Baseline, Week 8)
- Change From Baseline to Week 12 in Ashworth Scale Score for Wrist Flexors(Baseline, Week 12)
- Change From Baseline to Final Visit in Ashworth Scale Score for Wrist Flexors(Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest))
- Change From Baseline to Week 2 in Ashworth Scale Score for Finger Flexors(Baseline, Week 2)
- Change From Baseline to Week 4 in Ashworth Scale Score for Finger Flexors(Baseline, Week 4)
- Change From Baseline to Week 8 in Ashworth Scale Score for Finger Flexors(Baseline, Week 8)
- Change From Baseline to Week 12 in Ashworth Scale Score for Finger Flexors(Baseline, Week 12)
- Change From Baseline to Final Visit in Ashworth Scale Score for Finger Flexors(Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest))
- Change From Baseline to Week 2 in Ashworth Scale Score for Treated Thumb Flexors(Baseline, Week 2)
- Change From Baseline to Week 4 in Ashworth Scale Score for Treated Thumb Flexors(Baseline, Week 4)
- Change From Baseline to Week 8 in Ashworth Scale Score for Treated Thumb Flexors(Baseline, Week 8)
- Change From Baseline to Week 12 in Ashworth Scale Score for Treated Thumb Flexors(Baseline, Week 12)
- Change From Baseline to Final Visit in Ashworth Scale Score for Treated Thumb Flexors(Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest))
- Time to Onset of Treatment Effect(Period starting at Visit 2 (baseline injection) of the Main Period up to onset of treatment effect)
- Time to Waning of Treatment Effect(Defined as time (weeks) from Visit 2 (injection session at Baseline, Day 0) to the subjective estimation of the waning of the effect)
- Duration of Treatment Effect(Period from the day of injection until the time point of a need for a new injection agreed by the patient and the investigator)
- Investigator's Global Assessment of Efficacy(Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest))
- Patient's Global Assessment of Efficacy(Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest))
- Carer's Global Assessment of Efficacy(Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest))
- Change From Baseline to Week 2 in the Disability Assessment Scale for the Principal Therapeutic Target(Baseline, Week 2)
- Change From Baseline to Week 4 in the Disability Assessment Scale for the Principal Therapeutic Target(Baseline, Week 4)
- Change From Baseline to Week 8 in the Disability Assessment Scale for the Principal Therapeutic Target(Baseline, Week 8)
- Change From Baseline to Week 12 in the Disability Assessment Scale for the Principal Therapeutic Target(Baseline, Week 12)
- Change From Baseline to Final Visit in the Disability Assessment Scale for the Principal Therapeutic Target(Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest))
- Change From Baseline to Week 2 in the Disability Assessment Scale for Domain "Hygiene"(Baseline, Week 2)
- Change From Baseline to Week 4 in the Disability Assessment Scale for Domain "Hygiene"(Baseline, Week 4)
- Change From Baseline to Week 8 in the Disability Assessment Scale for Domain "Hygiene"(Baseline, Week 8)
- Change From Baseline to Week 12 in the Disability Assessment Scale for Domain "Hygiene"(Baseline, Week 12)
- Change From Baseline to Final Visit in the Disability Assessment Scale for Domain "Hygiene"(Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest))
- Change From Baseline to Week 2 in the Disability Assessment Scale for Domain "Dressing"(Baseline, Week 2)
- Change From Baseline to Week 4 in the Disability Assessment Scale for Domain "Dressing"(Baseline, Week 4)
- Change From Baseline to Week 8 in the Disability Assessment Scale for Domain "Dressing"(Baseline, Week 8)
- Change From Baseline to Week 12 in the Disability Assessment Scale for Domain "Dressing"(Baseline, Week 12)
- Change From Baseline to Final Visit in the Disability Assessment Scale for Domain "Dressing"(Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest))
- Change From Baseline to Week 2 in the Disability Assessment Scale for Domain "Limb Position"(Baseline, Week 2)
- Change From Baseline to Week 4 in the Disability Assessment Scale for Domain "Limb Position"(Baseline, Week 4)
- Change From Baseline to Week 8 in the Disability Assessment Scale for Domain "Limb Position"(Baseline, Week 8)
- Change From Baseline to Week 12 in the Disability Assessment Scale for Domain "Limb Position"(Baseline, Week 12)
- Change From Baseline to Final Visit in the Disability Assessment Scale for Domain "Limb Position"(Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest))
- Change From Baseline to Week 2 in the Disability Assessment Scale for Domain "Pain"(Baseline, Week 2)
- Change From Baseline to Week 4 in the Disability Assessment Scale for Domain "Pain"(Baseline, Week 4)
- Change From Baseline to Week 8 in the Disability Assessment Scale for Domain "Pain"(Baseline, Week 8)
- Change From Baseline to Week 12 in the Disability Assessment Scale for Domain "Pain"(Baseline, Week 12)
- Change From Baseline to Final Visit in the Disability Assessment Scale for Domain "Pain"(Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest))
- Change From Baseline to Week 4 in the Carer Burden Scale for Domain "Cleaning the Palm of the Affected Hand"(Baseline, Week 4)
- Change From Baseline to Week 12 in the Carer Burden Scale for Domain "Cleaning the Palm of the Affected Hand"(Baseline, Week 12)
- Change From Baseline to Final Visit in the Carer Burden Scale for Domain "Cleaning the Palm of the Affected Hand"(Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest))
- Change From Baseline to Week 4 in the Carer Burden Scale for Domain "Cutting the Fingernails of the Affected Hand"(Baseline, Week 4)
- Change From Baseline to Week 12 in the Carer Burden Scale for Domain "Cutting the Fingernails of the Affected Hand"(Baseline, Week 12)
- Change From Baseline to Final Visit in the Carer Burden Scale for Domain "Cutting the Fingernails of the Affected Hand"(Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest))
- Change From Baseline to Week 4 in the Carer Burden Scale for Domain "Cleaning the Armpit of the Affected Arm"(Baseline, Week 4)
- Change From Baseline to Week 12 in the Carer Burden Scale for Domain "Cleaning the Armpit of the Affected Arm"(Baseline, Week 12)
- Change From Baseline to Final Visit in the Carer Burden Scale for Domain "Cleaning the Armpit of the Affected Arm"(Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest))
- Change From Baseline to Week 4 in the Carer Burden Scale for Domain "Putting the Affected Arm Through the Sleeve (e.g., Coat, Shirt, Jacket)"(Baseline, Week 4)
- Change From Baseline to Week 12 in the Carer Burden Scale for Domain "Putting the Affected Arm Through the Sleeve (e.g., Coat, Shirt, Jacket)"(Baseline, Week 12)
- Change From Baseline to Final Visit in the Carer Burden Scale for Domain "Putting the Affected Arm Through the Sleeve (e.g., Coat, Shirt, Jacket)"(Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest))
- Change From Baseline to Week 4 in the Carer Burden Scale for Domain "Applying a Splint on the Affected Arm"(Baseline, Week 4)
- Change From Baseline to Week 12 in the Carer Burden Scale for Domain "Applying a Splint on the Affected Arm"(Baseline, Week 12)
- Change From Baseline to Final Visit in the Carer Burden Scale for Domain "Applying a Splint on the Affected Arm"(Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest))
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