NCT04936542已完成4 期
A Multicentre, Interventional, Post-marketing, Randomised, Double-blind, Crossover Study to Evaluate the Clinical Safety and Efficacy of AbobotulinumtoxinA (Dysport®) in Comparison With OnabotulinumtoxinA (Botox®) When Treating Adults With Upper Limb Spasticity
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 464
- 试验地点
- 152
- 主要终点
- Rate of Treatment-emergent Adverse Events (TEAEs)
研究概览
简要总结
This study is aiming to demonstrate the non-inferiority of AbobotulinumtoxinA (aboBoNT-A) versus OnabotulinumtoxinA (onaBoNT-A) as the primary safety endpoint, and the superiority of aboBoNT-A over onaBoNT-A with respect to duration of response as the key secondary efficacy endpoint when used at optimal doses according to approved prescribing information of each product.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant must be 18 to 80 years of age inclusive, at the time of signing the informed consent
- •2a. [US/France] Participants with stable Upper Limb Spasticity (ULS) for at least 3 months, in whom treatment of only one upper limb is necessary for the duration of the study;
- •2b. [Canada] Participants with stable post-stroke ULS for at least 3 months, in whom treatment of only one upper limb is necessary for the duration of the study
- •Participants who are either naïve to Botulinum toxin type A (BoNT-A) for ULS or who have been previously treated with BoNT-A for ULS;
- •Participants with MAS score of at least 2 at two muscle groups (one of these two muscles groups should be the PTMG) and at least 1 in the remaining muscle group.
- •Participants with DAS score of at least 2 on the Principal Target of Treatment (PTT) (one of four functional domains: dressing, hygiene, limb position and pain);
- •Participants who require BoNT-A injection in all of the following muscles: flexor carpi radialis, flexor carpi ulnaris, flexor digitorum profundus, flexor digitorum superficialis and biceps brachii;
- •Participants for whom injection of a total dose of 900 Units aboBoNT-A or 360 Units onaBoNT-A is considered by the investigator to be clinically appropriate;
- •Participants who have been stable for at least 3 months prior to study entry in terms of oral antispasticity, anticoagulant and/or anticholinergic medication if treated are considered by the investigator likely to remain stable for the duration of the study;
- •Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- •Male participants: Male participants must agree that, if their partner is at risk of becoming pregnant, they will use an effective method of contraception. The participants must agree to use the contraception during the whole period of the study.
- •Female participants:A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies:
- •Is a woman of non-childbearing potential, defined as postmenopausal for at least
- •1 year; surgical sterilisation at least 3 months before entering the study; or hysterectomy. or
- •Is a woman of childbearing potential (WOCBP) and using an acceptable contraceptive method during the entire study period.A WOCBP must have a negative highly sensitive pregnancy test at screening (urine or serum) as required by local regulations.
排除标准
- •Major limitations in the passive range of motion in the paretic upper limb;
- •Major neurological impairment (other than limb paresis) that could negatively affect functional performance;
- •Participants clinically requiring injection into any upper limb muscles other than the five muscles of one arm listed in Section 5.1, or requiring injection into both arms or any lower limb within the timeframe of the study;
- •Hypersensitivity to any BoNT product or excipients;
- •Hypersensitivity to cow's milk protein (casein);
- •Infection at the proposed injection site(s);
- •Known peripheral motor neuropathic diseases, amyotrophic lateral sclerosis or neuromuscular junction disorders (e.g. myasthenia gravis or Lambert-Eaton syndrome);
- •Any medical condition (including dysphagia or breathing difficulties/compromised respiratory function) that in the opinion of the investigator, might jeopardize the participant's safety;
- •abnormal screening/baseline findings or any other medical condition(s) that, in the opinion of the investigator, might jeopardise the participant's safety
- •Women who are pregnant or lactating
- •In the clinical judgement of the investigator, BoNT treatment is inappropriate
- •BoNT naïve participants with a history of facial neurogenic disorder (facial paralysis, polyradiculoneuropathy) (only for France)
- •Participants treated with BoNT of any type for any indication (e.g. bladder injection, headache or cosmetic) within the previous 12 weeks or planned/likely to be treated during the course of the study;
- •Prior history of non-responsiveness to BoNT treatment;
- •Previous surgery, or administration of alcohol or phenol in the study limb 6 months or earlier from study enrolment or planned/likely to be treated during the course of the study;
- •Participants treated with intrathecal baclofen (except if treatment has reached a stable dose for >4 weeks and is likely to remain stable throughout the study), aminoglycosides or other agents interfering with neuromuscular transmission (e.g. curare-like agents) within the 4 weeks prior to study enrolment or planned/likely to be treated during the course of the study
- •Participants receiving concomitant medication treatment with the following PT/OT interventions on the study limb: new splinting/orthotics/casting, serial casting, shockwave therapy, dry needling and needle tenotomies. However, PT/OT interventions not intended to reduce study limb spasticity (e.g. functional training exercises) or with a transient (<1 day) reduction of study limb spasticity (e.g. stretching, weight bearing) are allowed.
- •Participants previously randomised for this study
- •Participants unwilling or unable to understand the nature, scope and possible consequences of the study and to comply with study procedures and requirements
- •Participants currently enrolled in any other clinical study or have participated in one within the 12 weeks (or 5 half-lives of the investigational product of that study, whichever is longer) prior to enrolment/inclusion visit, or are scheduled to receive a new investigational drug while the study is ongoing
研究组 & 干预措施
Sequence 2
Other
Participants will receive one cycle of onaBoNT-A followed by one cycle of aboBoNT-A in the selected overactive upper limb muscles
干预措施: AboBoNT-A (Biological)
Sequence 1
Other
Participants will receive one cycle of aboBoNT-A followed by one cycle of onaBoNT-A in the selected overactive upper limb muscles
干预措施: AboBoNT-A (Biological)
Sequence 1
Other
Participants will receive one cycle of aboBoNT-A followed by one cycle of onaBoNT-A in the selected overactive upper limb muscles
干预措施: OnaBoNT-A (Biological)
Sequence 2
Other
Participants will receive one cycle of onaBoNT-A followed by one cycle of aboBoNT-A in the selected overactive upper limb muscles
干预措施: OnaBoNT-A (Biological)
结局指标
主要结局
Rate of Treatment-emergent Adverse Events (TEAEs)
时间窗: from baseline (injection) to 12 weeks (injection cycle 1 and 2, each cycle is a maximum 24 weeks))
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) From Injection to 12 Weeks
时间窗: From Baseline (Injection: Day 1) up to 12 weeks
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. A TEAE was defined for each treatment cycle as any AE that occurred during the cycle if it was not present prior to treatment injection, or it was present prior to treatment injection but the intensity increased during the cycle. Percentage of participants with TEAEs that occurred during each cycle from injection to 12 weeks after injection (until 84 days after injection or until the day prior to next injection day or until end of study/early withdrawal day whichever occurred first) is presented. Percentages are rounded off to the tenth decimal place.
次要结局
- Duration of response(baseline (injection) to retreatment criteria met, from week 10 up to week 24 (for each cycle, 1&2) or baseline to withdrawal or end of study if retreatment criteria not met, up to 24 weeks (for each cycle,1&2, each cycle is a maximum 24 weeks))
- Rate of Adverse Drug Reactions (ADRs), Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs)(from baseline (injection) to 12 weeks (injection cycle 1 and 2, each cycle is a maximum 24 weeks)))
- Muscle tone assessed by Modified Ashworth scale (MAS) total score(at baseline (injection), 1 week, 4 weeks, 10 weeks, 12 weeks and additional visits at 16 weeks, 20 weeks, 24 weeks (injection cycle 1 and 2; each cycle is a maximum 24 weeks))
- Perceived function and pain assessed by the Disability Assessment Scale (DAS) total score(at baseline (injection), 1 week, 4 weeks, 10 weeks, 12 weeks and additional visits at 16 weeks, 20 weeks, 24 weeks (injection cycle 1 and 2; each cycle is a maximum 24 weeks))
- Change in Quality of Life (QoL) using the SF-12 perceived health score(at baseline (injection), 4 weeks, 12 weeks and at end of each cycle (injection cycle 1 and 2; each cycle is a maximum 24 weeks))
- Change in Quality of Life (QoL) using SQoL-6D(at baseline (injection), 4 weeks, 12 weeks and at end of each cycle (injection cycle 1 and 2; each cycle is a maximum 24 weeks))
- Physician global assessment (PGA) of treatment response(at baseline (injection), 1 week, 4 weeks, 10 weeks, 12 weeks and additional visits at 16 weeks, 20 weeks, 24 weeks (injection cycle 1 and 2; each cycle is a maximum 24 weeks))
- Number of Participants With Adverse Drug Reactions (ADRs), Treatment-Emergent Serious Adverse Events (TESAEs) and Adverse Events of Special Interest (AESIs) From Injection to 12 Weeks(From Baseline (Injection: Day 1) up to 12 weeks)
- Adjusted Least Square Mean of Duration of Response Based on Retreatment Criteria(Baseline (Day 1) up to Week 10 (earliest) if retreatment criteria were met, or up to Week 24 (latest) if retreatment criteria were not met)
- Adjusted Least Square Mean of Muscle Tone Assessed by the Modified Ashworth Scale (MAS) for Finger, Wrist and Elbow Flexors Based on Primary Target Muscle Group (PTMG) at Week 12(Week 12 (Cycles 1 and 2; each cycle was 12 to 24 weeks))
- Adjusted Least Square Mean of Perceived Function and Pain Assessed by the Disability Assessment Scale (DAS) Based on Principal Target of Treatment (PTT) at Week 12(Week 12 (Cycles 1 and 2; each cycle was 12 to 24 weeks))
- Adjusted Least Square Mean of Physician Global Assessment (PGA) of Treatment Response at Week 12(Week 12 (Cycles 1 and 2; each cycle was 12 to 24 weeks))
- Change From Baseline to Weeks 4, 12 and 24 (End of Cycle) in Quality of Life (QoL) Assessed by the 12-Item Short Form (SF-12) Health Survey Perceived Health Score: Physical Component Summary (PCS-12) and Mental Component Summary (MCS-12) Scores(Baseline (Day 1) and Weeks 4, 12, and 24 (end of cycle) (Cycles 1 and 2; each cycle was 12 to 24 weeks))
- Change From Baseline to Weeks 4, 12 and 24 (End of Cycle) in Quality of Life Assessed by the Spasticity-Related Quality of Life Tool (SQoL-6D)(Baseline (Day 1) and Weeks 4, 12, and 24 (end of Cycle) (Cycles 1 and 2; each cycle was 12 to 24 weeks))
研究者
研究点 (152)
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