EUCTR2019-003948-71-BG进行中（未招募）1 期
AN INTEGRATED PHASE I/II, MULTICENTRE, DOUBLE-BLIND, RANDOMISED, DYSPORT AND PLACEBO-CONTROLLED, DOSE ESCALATION AND DOSE-FINDING STUDY TO EVALUATE THE SAFETY AND EFFICACY OF IPN59011 IN THE TREATMENT OF ADULT UPPER LIMB SPASTICITY
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 209
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
- •Subjects must fulfil all the following criteria to be included in the study:
- •(1) Provision of written informed consent prior to any study related procedures.
- •(2) Female and male subjects between:
- •For Stage 1: 18 and 65 years of age, inclusive.
- •For Stage 2 and Stage 3: 18 and 70 years of age, inclusive.
- •(3) Have spastic hemiparesis following stroke or TBI.
- •(4) Are at least 6 months post-stroke or TBI.
- •(5) Have never received BoNT or if previously treated, should have received their last
- •injection of any commercialised BoNT-A or B at least 4 months prior to study Baseline.
- •(6) Have a MAS score =2 in the PTMG to be injected:
- •For Stage 1: subjects should have a clenched fist with a MAS score =2 in the
- •extrinsic finger flexors.
- •For Stage 2: subjects should have one or more clinical pattern(s) in addition to
- •flexed elbow with a MAS score =2 in elbow flexors.
- •For Stage 3: subjects should have two or more clinical pattern(s) in addition to
- •adducted/rotated shoulder with a MAS score =2 in adducted/rotated shoulder
- •(7) Should also be eligible to receive a total recommended dose 1000 U Dysport in the upper limb for Stage 2.
- •(8) Angle of spasticity =5° in the PTMG to be injected.
- •(9) Should not have any fixed contractures as defined by:
- •Complete fingers extension with XV1 =160°
- •Complete wrist extension with XV1 =90°
- •Complete elbow extension with XV1 =160°
- •(10) Physical therapy, occupational therapy, splinting, use of benzodiazepine, and muscle
- •relaxants had to be stable from at least 30 days preceding the study Baseline until the end of the study.
- •(11) Subjects in good health (i.e. absence of any uncontrolled systemic disease or other significant medical condition) as determined by medical history, physical and
- •neurological examinations, clinical laboratory studies, electrocardiograms (ECGs), vital signs, and Investigator's judgement prior to randomisation.
- •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 200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 9
排除标准
- •Subjects will be excluded from the study if they meet any of the following criteria:
- •(1) Likely treatment with any serotype of BoNT for any condition during the study.
- •(2) Undergone previous surgery to treat spasticity in the affected upper limb.
- •(3) Has initiated physiotherapy within 30 days prior to Baseline (if physiotherapy initiated
- •more than 30 days prior to Baseline and ongoing, the therapy regimen should be
- •maintained at the same frequency and intensity throughout the study if possible or at least
- •up to post-injection 3-months).
- •(4) Has received previous treatment with phenol and or alcohol in the targeted upper limb any time before the study.
- •(5) Has been treated or is likely to be treated with intrathecal baclofen during the 30 days
- •prior to study Baseline or during the course of the study.
- •(6) Current or planned treatment with any medications that interfere either directly or indirectly with neuromuscular transmission, such as curare-like non-depolarising agents, lincosamides, polymyxins, anticholinesterases and aminoglycoside antibiotics, within
- •30 days prior to Baseline.
- •(7) Use of concomitant therapy which, in the investigator’s opinion, would interfere with the evaluation of the safety or efficacy of the study treatment, including medications affecting bleeding disorders, provided the International normalized ratio (INR) is controlled between 2 and 3 (antiplatelet agents and/or anticoagulants given for treatment or prevention of cardiovascular/cerebrovascular diseases).
- •(8) Treatment with an experimental drug or use of any experimental device within 30 days prior to the study Baseline and during the conduct of the study.
- •(9) Currently planned or a history of tendon lengthening surgery, significant contracture or muscle atrophy at target joint or muscle in the past 6 months prior to Screening.
- •(10) Any medical condition (including severe dysphagia or airway disease) that may increase, in the opinion of the investigator, the likelihood of adverse events (AEs) related to BoNT treatment.
- •(11) Known disease of the neuromuscular junction (e.g. Lambert-Eaton myasthenic syndrome, myasthenia gravis or amyotrophic lateral sclerosis etc.).
- •(12) Has a history of hypersensitivity to the investigational medicinal products (or other BoNTs) or any excipient used in their formulation.
- •(13) Infection at the injection site(s).
- •(14) A history of drug or alcohol abuse.
- •(15) Clinically diagnosed significant anxiety disorder, or any other significant psychiatric disorder (e.g. depression) that might interfere with the subject’s participation in the study.
- •(16) Inability to understand protocol procedures and requirements which, in the opinion of the investigator, could negatively impact on protocol compliance or inability or unwillingness to comply with the protocol.
- •(17) Presence of any other condition (e.g. neuromuscular disorder or other disorder that could interfere with neuromuscular function), laboratory finding or circumstance that, in the judgement of the investigator, might increase the risk to the subject or decrease the chance of obtaining satisfactory data to achieve the objectives of the study.
- •(18) Pregnant women, or women of childbearing potential not willing to practice a highly effective form of contraception method at the beginning of the study, for the duration of the study and for a minimum of 12 weeks following last administration of study treatment. Highly effective methods of contraception are defin
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