Study on the Use of Botulinum Toxin Type A in the Treatment of Chronic Post-stroke Spastic Patients

Completed

• Conditions: Spasticity

• Registration Number: NCT02390206
• Lead Sponsor: Ipsen

Brief Summary

The purpose of this study is to document the effectiveness of treating chronic post-stroke spastic patients with Botulinum Toxin type A.

Detailed Description

As this is a non-interventional study, the decision to prescribe the product must be taken prior to, and independently from the decision to enrol the patient. This decision should be made in accordance with routine clinical practice at the hospital concerned. The clinical justification for prescribing any treatment should be recorded at the outset by the prescribing clinician.

This study will not interfere with the routine practice of the investigator or with the patient's treatment plan. Assessments will be done only if performed regularly in routine practice.

This study will be conducted in Brazil, wherein Marketing Authorization has been granted for the use of BoNT-A in the treatment of spasticity of the upper and lower limb in adult post-stroke patients.

Study Timeline

• Study First Submitted: 2015-03-04
• Study First Submitted QC: 2015-03-10
• Study First Posted: 2015-03-17
• Study Start: 2015-06
• Primary Completion: 2017-08-28
• Study Completion: 2017-08-28
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-29
• Last Update Posted: 2017-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 239

Inclusion Criteria

• Time between last documented stroke (either haemorrhagic or ischemic) and study inclusion date equal or longer than 1 year
• Documented upper limb spasticity, with or without lower limb spasticity
• Naive to BoNT-A injections for spasticity treatment
• Provide written informed consent (signed by the patient or his legal representative) prior to any study-related procedure

Exclusion Criteria

• Previous surgical procedure for spasticity treatment, including neurotomy, rhizotomy and intrathecal pump implants
• Previous phenol injection and/or indication to receive phenol during the study duration
• Contraindications to any BoNT-A preparations
• Patient and/or caregiver unable to comply with the study requirements
• The patient has already been included in the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Goal Achievement Score (GAS).	3 and 6 months

Secondary Outcome Measures

Name	Time	Method
Change from baseline in functional independence according to Barthel index score	Baseline and 3 months
Change from baseline in pain according to Verbal Numerical Scale (VNS).	Baseline and 3 months
Change from baseline in Modified Ashworth Scale (MAS) score	Baseline and 3 months
Change from baseline in Quality of Life according to Euro-5D-5L health questionnaire	Baseline and 3 months

Trial Locations

Locations (11)

Hospital Alemão Oswaldo Cruz; 🇧🇷 São Paulo, Brazil

Centro Catarinense de Reabilitação; 🇧🇷 Florianópolis, Brazil

Hospital Bettina Ferro de Souza Campus IV da Universidade Federal do Pará; 🇧🇷 Belém, Brazil

Centro de Reabilitação e Readaptação Dr. Henrique Santillo; 🇧🇷 Goiânia, Brazil

Clinica Neurológica e Neurocirúrgica de Joinville; 🇧🇷 Joinville, Brazil

Instituto de Reabilitação Lucy Montoro - FAMERP; 🇧🇷 São José do Rio Preto, Brazil

Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto; 🇧🇷 Ribeirão Preto, Brazil

Hospital Universitário Clementino Fraga Filho (HUCFF); 🇧🇷 Rio de Janeiro, Brazil

Irmandade da Santa Casa de Misericórida de São Paulo; 🇧🇷 São Paulo, Brazil

HCSP - Complexo Hospital das Clinicas Instituto de Medicina Fisica e Reabilitação; 🇧🇷 São Paulo, Brazil

Hospital São Paulo - UNIFESP; 🇧🇷 São Paulo, Brazil