A study investigating single injection of new botulinum toxin to determinesafety and efficacy for treating spasticity in the upper limb
- Conditions
- pper limb spasticity after stroke or traumatic brain injuryMedDRA version: 20.0Level: LLTClassification code 10041416Term: SpasticitySystem Organ Class: 100000004852Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2019-003948-71-CZ
- Lead Sponsor
- Ipsen Innovation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 209
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
flexors.
(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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method