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

Ipsen

Status: Completed

Conditions: Spasticity

Study type: Observational

Funder types: Industry

Identifiers

NCT02390206

A-38-52120-202

Details and patient eligibility

About

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

Full 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.

Enrollment: 239 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

239 participants in 1 patient group

Botulinum toxin type A (BoNT-A) injection Naïve

Description:

Subjects naïve to BoNT-A treatment. Investigators follow their individual injection protocol for treatment with BoNT-A (modalities of administration in accordance with local Summary of Product Characteristics and locally agreed therapeutic guidelines).