Post-stroke patients MedDRA version: 9.1 Level: LLT Classification code 10052469 Term: Postictal paralysis
Conditions
Interventions
Trade Name: xeomin
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Botulinum toxin
Concentration unit: U unit(s)
Concentration type: equal
Concentration number: 100-
Sponsors
AZIENDA SANITARIA LOCALE N 15 DI CUNEO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Post-stroke (ischaemic or hemorrhagic) patients - Lower-limb spasticity with equinovarus (including dynamic equinovarus)- Female or male patients, ≥ 18 - 75 years - For pre-treated patients only: source documentation of the most recent injection session with Botulinum Toxin and sufficient therapeutic response for equinovarus - For pre-treated patients only: Stable treatment with oral antispastic drugs of ≥3 weeks. - Autonomous walking (with or without aid) for at least 10 meters - Ashworth Scale ≥1 of the plantar flexors - Ashworth Scale ≥1 of the ankle/foot invertors - Foot plantiflexion during swing phase - Foot inversion during swing phase - maximum active ankle ROM at least limited to 10 in the affected side. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Limited passive ankle dorsiflexion >0 - Flaccid drop foot - Planned concomitant treatment with Botulinum Toxin of any serotype and for any body region - Previous or planned treatment with phenol- or alcohol-injection in the target limb - Previous surgical treatment of spasticity in the target muscle(s) - Severe atrophy of the target limb muscles - Limited passive ankle pronation Please define - Pregnancy and lactation - Non complete rehabilitation program which is during the last 4 weeks preceding screening - - Mini Mental State Examination 2.5 on injection day - Result of hematological/clinical chemistry-analysis at baseline which is considered as abnormal and clinically significant (ie indicating the presence of a severe or uncontrolled systemic disease).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the efficacy of Xeomin in the treatment of patients with equinovarus foot due to spasticity after stroke.;Secondary Objective: To document the safety profile of Xeomin;Primary end point(s): To evaluate spasticity of ankle plantiflexors (Primary endpoint) and invertors by the Ashworth Scale | — |
Countries
Italy
Outcome results
None listed