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

An Observational, Prospective, Multicentre, National Trial on the Benefit of Botulinum Toxin Type A (BoNT-A) Injections in Untreated Chronic Post-stroke Spastic Brazilian Patients

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02390206

Acronym

B-CAUSE

Enrollment

239

Registered

2015-03-17

Start date

2015-06-30

Completion date

2017-08-28

Last updated

2017-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spasticity

Keywords

Stroke, Spasticity, Botulinum Toxin type A, Dysport

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame
Change in Goal Achievement Score (GAS).	3 and 6 months

Secondary

Measure	Time frame
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 functional independence according to Barthel index score	Baseline and 3 months
Change from baseline in Quality of Life according to Euro-5D-5L health questionnaire	Baseline and 3 months

Countries

Brazil

Outcome results