Prospective, open-label, multi-center trial to investigate efficacy and safety of Xeomin in the treatment of post-stroke spasticity in the lower limb - ND

• Conditions: Post-stroke patients; MedDRA version: 9.1Level: LLTClassification code 10052469Term: Postictal paralysis

• Registration Number: EUCTR2007-003817-15-IT
• Lead Sponsor: AZIENDA SANITARIA LOCALE N 15 DI CUNEO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11-12
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

- 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 <24 - Previous focal treatments for lower limb spasticity. Except treatment with Botulinum Toxin ≥ 5 months before screening visit. - Fixed contracture, defined as severe restriction of the range of joint movement on passive stretch of ankle or knee - Impaired function of lower limb due to any other condition than post-stroke equinovarus. - Severe or uncontrolled systemic disease. - Other muscle hypertonia, e.g., rigidity - INR value > 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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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