Upper limb spasticity post stroke or traumatic brain injury. MedDRA version: 17.0 Level: LLT Classification code 10048970 Term: Arm spasticity System Organ Class: 100000004852
Conditions
Interventions
Trade Name: Dysport
Product Name: Dysport
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Clostridium Botulinum Toxin Type A-Hemagglutinin Complex
Other descriptive name: C
Sponsors
Institut Produits Synthèse (IPSEN) AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: o Provision of written informed consent prior to any study related procedures, o Subjects male or female, aged 18 or older, o Upper limb spasticity post stroke or traumatic brain injury, o Spasticity position pattern type 1, 3 or 4, o Elbow flexor muscles spasticity MAS 2 to 3, o At least 2 consecutive previous treatment cycles of BoNT-A for current diagnosis, o The latest treatment cycle demonstrating good treatment efficacy where the Dysport dose administered was considered to be adequate according to Investigator judgement, oNeed of the same treatment modality in m. brachialis, m. biceps brachii, m. brachioradialis, m. flex. carpi ulnaris, m. flex. carpi radialis as the previous treatment cycle, o Last BoNT-A treatment 12-24 weeks ago 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 78 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 180
Exclusion criteria
Exclusion criteria: Subjects will not be included in the study if they meet any or the following criteria: • Poor response to BoNT-A treatment, according to Investigator, • Need of Dysport doses >800U in the upper limb, • Concomitant treatment with BoNT-A for other indications than spasticity, • Any elbow flexor contracture prohibiting MAS evaluation and/or elbow flexion improvement of at least 1 step on the MAS • Cutaneous or joint inflammation in the affected upper limb, • Is likely to start other spasticity treatment during the study, • Is likely to start physiotherapy treatment during the study, • Other ongoing neurological disorder (e.g., myasthenia gravis), • History of dysphagia or aspiration, • Use of agents interfering with neuromuscular transmission (e.g., aminoglycosides), • Treated with an investigational medicinal product within 30 days before start of the study, • Known sensitivity to BoNT-A or any components of Dysport, • Is at risk of pregnancy or is lactating. Females of childbearing potential must provide a negative pregnancy test (U-hCG) at visit 1 and must be using adequate contraception. Non childbearing potential is defined as post-menopause for at least one year, surgical sterilisation or hysterectomy at least three months before the start of the study, • Has a history of, or known current, problems with alcohol or drug abuse, • Has a mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude, • Has abnormal baseline findings, any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardise the subject’s safety or decrease the chance of obtaining satisfactory data needed to achieve the objective(s) of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to compare Dysport treatment results after current clinical practice technique and 300U/mL dilution (high-concentration, Group 1) to the neuromascular junction (NMJ) targeted technique and 100U/mL dilution (low-concentration, Group 2), in the elbow joint assessed by Modified Ashworth Scale (MAS, Appendix 3) 4 weeks post treatment. ;Secondary Objective: • Elbow joint, assessed by MAS, 12 weeks post treatment • Pain associated with spasticity, assessed by VAS, at visit 1(baseline, day 1), 4 and 12 weeks post treatment • Pain associated with injection technique, assessed by VAS, at visit 1 • GAS responder rate, as defined by the achievement of the primary goal related to the elbow flexion from the GAS, 4 or 12 weeks post treatment depending on the time point defined at the baseline visit • Subject global evaluation of the treatment effect, at the end of the study (visit 3 or 4) compared to previous treatment cycle • Safety, based on treatment emergent adverse event - Investigator global preference of current clinical practice vs. the NMJ targeted injection technique when all subjects at the site have completed the study (LPLV of each site). ;Primary end point(s): MAS of elbow flexors at 4 weeks ;Timepoint(s) of evaluation of this end point: 4 weeks post treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • MAS of elbow flexors at 12 weeks Change from baseline to week 12 for elbow flexors muscle tone as measured by the MAS. • Spasticity pain measured by VAS. Mean change from baseline to week 4 and 12 of spasticity related pain, assessed by the subject. The VAS ruler used in this study will be a straight 10 cm horizontal line with anchor points of No pain (score 0) and Worst pain imaginable (score 10). • Injection pain measured by VAS. Subject perceived injection site pain at day 1. The VAS ruler used in this study will be a straight 10 cm horizontal line with anchor points of No pain (score 0) and Worst pain imaginable (score 10). • Achievement of the primary goal measured by GAS. At baseline, the investigator will interview the subject to identify the main problem area and establish an agreed primary goal related to elbow flexion to be followed up at week 4 or 12 depending on the time point defined at the baseline visit. • Subject global evaluation of treatment effect. Comparison of treatment effect between previous (pre study) and study treatment cycles assessed by the subject at the end of study (visit 3 or 4) Categorised as follows: Much worse / Worse / Same / Better / Much better. • Investigator preference of injection technique. When all subjects at the site have completed the study (Last Patient Last Visit, LPLV) a global assessment of the preference of injection technique will be made by the Investigator. Safety Endpoints and Evaluations: • Adverse Events (AEs) Adverse events will be monitored from the subject gives informed consent (visit 1, day 1) to the time when the subject’s participation in the study has ended (visit 3 or 4). AEs will be elicited by direct, non-leading questioning at each clinic visit or by spontaneous reports. ;Timepoint(s) of evaluation of this end point: 4, 12 and 13-24 weeks. | — |
Countries
Denmark, Finland, Sweden
Contacts
Public ContactMedical Department
Institut Produits Synthèse (IPSEN) AB
Outcome results
None listed