2023-509196-16-00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
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Ipsen Pharma
- 入组人数
- 50
- 试验地点
- 16
- 主要终点
- Rate of TEAEs from injection to 12 weeks
研究概览
简要总结
To demonstrate non-inferiority as per safety assessment based on the rate of all TEAEs from injection to 12 weeks
研究设计
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- Double (Carer, Subject, Investigator)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 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
- •Capable of giving signed informed consent as described in Section 10.1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
- •2.a. [US/France] Participants with stable 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 BoNT-A for ULS or who have been previously treated with BoNT-A for ULS
- •Participants with MAS score of at least 2 in two muscle groups (one of these two muscle groups should be the PTMG) and at least 1 in the remaining muscle group
- •Participants with DAS score of at least 2 on the 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, and are considered by the investigator likely to remain stable for the duration of the study
- •Male and female participants Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. a. 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. b. 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 as described in protocol section 10.4.
- •A WOCBP must have a negative highly sensitive pregnancy test at screening (urine or serum) as required by local regulations. •If a urine test cannot be confirmed as negative (e.g. an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive
排除标准
- •Major limitations in the passive range of motion in the paretic upper limb
- •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
- •Prior history of non-responsiveness to BoNT treatment
- •Previous surgery, or administration of alcohol or phenol in the study limb within the 6 months prior to study enrolment or planned/likely to be treated in the study limb 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 previous 4 weeks prior to study enrolment or planned/likely to be treated during the course of the study
- •Participants receiving concomitant 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
- •Women who are pregnant or lactating
- •Participants currently enrolled in any other clinical study or have participated in one within the 12 weeks (or 5 half-lives of 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
- •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
- •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 protocol 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)
研究组 & 干预措施
BOTOX 200 UNITÉS ALLERGAN, poudre pour solution injectable
Test
干预措施: BOTOX 200 UNITÉS ALLERGAN, poudre pour solution injectable (Drug)
DYSPORT 500 UNITES SPEYWOOD, poudre pour solution injectable
Test
干预措施: DYSPORT 500 UNITES SPEYWOOD, poudre pour solution injectable (Drug)
结局指标
主要结局
Rate of TEAEs from injection to 12 weeks
Rate of TEAEs from injection to 12 weeks
次要结局
- Rate of ADRs, SAEs and AESIs from injection to 12 weeks
- Duration of response based on retreatment criteria
- Muscle tone assessed by the MAS for finger, wrist and elbow flexors at 1, 4, 10, 12 ± 16, 20, 24 weeks based on PTMG and MAS total score
- Perceived function and pain assessed by the DAS at 1, 4, 10, 12 ± 16, 20, 24 weeks based on PTT and DAS total score
- PGA of treatment response at 1, 4, 10, 12 ± 16, 20, 24 weeks
- QoL, using the SF-12 perceived health score and SQoL-6D at 4 weeks, 12 weeks and at end of each cycle
研究者
Ipsen Clinical Study Enquiries
Scientific
Ipsen Pharma
研究点 (16)
Loading locations...
相似试验
招募中
1 期
An early Phase 1b Study to assess how safe and effective is the treatment with drugs, called Mosunetuzumab or Glofitamab in Combination with drugs called, CC-220 and CC-99282 in Patients with B-Cell Non-Hodgkin Lymphoma.2023-505185-28-00F. Hoffmann-La Roche AG52
尚未招募
1 期
LPM6690176 in Combination With Chemotherapy and Bevacizumab in Metastatic Colorectal Cancer Patients With RAS MutationNCT07391566Luye Pharma Group Ltd.99
招募中
2 期
A study to evaluate the safety and efficacy of the tumor-targeting human antibody-cytokine fusion protein L19TNF plus standard temozolomide (TMZ) chemoradiotherapy in patients with newly diagnosed glioblastomaGlioblastoma2024-516357-46-00Philogen S.p.A.70
尚未招募
Unknown
Evaluate the Safety and Effectiveness of Oral Suspension of Sodium Alginate IP 1000 mg and Potassium hydrogen carbonate Ph EUR 200 mg in 320 Patients with Gastroesophageal Reflux Disease (GERD) or acidity.CTRI/2025/10/096431Ms Abbott India Limited320
Enrolling By Invitation
不适用
Persona SoluTion PPS Femur PMCFNCT07286513Zimmer Biomet200