Leg Spasticity MedDRA version: 14.1 Level: LLT Classification code 10024132 Term: Leg spasticity System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: DYSPORT™ for Injection
Pharmaceutical Form: Powder for solution for injection
CAS Number: 93384-43-1
Other descriptive name: BOTULINUM TOXIN TYPE A
Concentration unit: U unit(s)
Concentrat
Sponsors
Ipsen Pharma SAS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects who have completed the double blind study (Study 140), up to the Week 12, Week 16, Week 20 or Week 24 follow up visit, and who do not have any major protocol deviation and/or any ongoing AEs (either of which, in the opinion of the Investigator, would pose an unacceptable risk to the subjects were they to continue receiving treatment) will be eligible for the study. Additionally, an informed consent for this open label extension study will be signed. 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 191 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 157
Exclusion criteria
Exclusion criteria: • Major limitation in the passive range of motion at the affected hip, knee or ankle, as defined by: ° maximum passive hip flexion (knee flexed) < 30º, ° maximum passive knee flexion (hip flexed) < 70º, ° maximum passive ankle dorsiflexion (knee flexed) < 10º, ° maximum passive knee extension < 160º. • Previous surgery to treat spasticity on the affected muscles and ligaments, tendons or nerve trunks of the treated lower limb. • Previous treatment with phenol and/or alcohol in the treated lower limb at any time before the study. • Cognitive impairment altering the capacity to comply with the trial according to Investigator's judgement. • Severe neurological impairment (not associated with the stroke or brain trauma) due to an underlying neuromuscular disease or any other underlying disease or condition affecting gait (for example, Multiple Sclerosis). • Known disease of the neuromuscular junction (such as Lambert Eaton myasthenic syndrome or myasthenia gravis). • Unwillingness or inability to comply with the protocol. • Major hypoaesthesia or ataxia on the paretic side. • Known sensitivity to Botulinum toxin (BTX) or any Dysport excipients. • Infection at the injection site(s). • Current or planned treatment with any drug that interferes either directly or indirectly with neuromuscular function (for example, aminoglycosides) within the last 4 weeks prior to study treatment. • Pregnant women, or premenopausal women not willing to use contraceptive measures throughout the duration of the study. • Treatment with a new investigational drug within 4 weeks prior to enrolment into the study or scheduled treatment with such a drug during the study period. • Any medical condition (or laboratory finding), that in the opinion of the Investigator may compromise compliance with the objectives and/or procedures of this protocol or preclude the administration of BTX. • Subjects treated or likely to be treated with intrathecal baclofen during the course of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary study objective is to assess the long term safety of Dysport in hemiparetic subjects with lower limb spasticity due to stroke or traumatic brain injury over repeated Treatment Cycles.;Secondary Objective: The secondary study objective is the assessment of the long term efficacy including: • Muscle tone in the gastrocnemius-soleus complex (GSC) (knee extended), • Muscle tone in the soleus muscle (knee flexed), • Physician’s Global Assessment (PGA) of treatment response, • Maximal and comfortable barefoot walking speeds, • Maximal and comfortable walking speeds with shoes, • Spasticity in the GSC (knee extended), • Spasticity in the soleus muscle (knee flexed), • Step length and cadence under different conditions, • Range of active ankle dorsiflexion, • Lower limb pain, • Quality of life (QoL), • Use of walking aids. ;Primary end point(s): Safety endpoints: • Adverse events. • Vital signs (systolic and diastolic BP and HR) at Day 1 of Treatment Cycle 1 and at each study visit. • Clinical laboratory parameters at Day 1 of Treatment Cycle 1, Week 4 of each Treatment Cycle and at the end of study or early withdrawal (haematology and clinical chemistry). • Presence of BTX A Abs at Day 1 of Treatment Cycle 1, Week 4 of each Treatment Cycle and at the end of study or early withdrawal. The antibodies will be measured in serum samples, initially by screening radioimmunoprecipitation assay (RIPA). If RIPA is positive, the result will be confirmed by a competitive RIPA confirmatory assay. Samples positive for the presence of binding antibodies in both the screening and confirmatory RIPAs, will be analysed for the presence of neutralising antibodies using the mouse protection assay (MPA). • A 12 lead ECG performed at Day 1 of Treatment Cycle 1, Week 4 of each Treatment Cycle and at the end of study or early withdrawal. Efficacy endpoints: In all of the following endpoints, the baseline is defined as the baseline in the double blind study. • | — |
Countries
Belgium, Czech Republic, Hungary, Italy, Portugal
Outcome results
None listed