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

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

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

Study Overview

• Status: Completed
• Conditions: Spasticity

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 Type: Observational
• Enrollment (Actual): 239

Contacts and Locations

Study Locations

• Brazil
  • Belém, Brazil, 66045-110
    • Hospital Bettina Ferro de Souza Campus IV da Universidade Federal do Pará
  • Florianópolis, Brazil, 88025-301
    • Centro Catarinense de Reabilitação
  • Goiânia, Brazil, 74653-230
    • Centro de Reabilitação e Readaptação Dr. Henrique Santillo
  • Joinville, Brazil, 89202-165
    • Clinica Neurologica e Neurocirurgica de Joinville
  • Ribeirão Preto, Brazil, 14048-900
    • Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
  • Rio de Janeiro, Brazil, 21941-913
    • Hospital Universitário Clementino Fraga Filho (HUCFF)
  • São José do Rio Preto, Brazil, 1591-240
    • Instituto de Reabilitação Lucy Montoro - FAMERP
  • São Paulo, Brazil, 01221-010
    • Irmandade da Santa Casa de Misericórida de São Paulo
  • São Paulo, Brazil, 01323-903
    • Hospital Alemao Oswaldo Cruz
  • São Paulo, Brazil, 04024-002
    • Hospital São Paulo - UNIFESP
  • São Paulo, Brazil, 05403-900
    • HCSP - Complexo Hospital das Clinicas Instituto de Medicina Fisica e Reabilitação

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Untreated chronic post-stroke spastic patients

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Botulinum toxin type A (BoNT-A) injection Naïve; 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).

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Ipsen

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): August 28, 2017
• Study Completion (Actual): August 28, 2017

Study Registration Dates

• First Submitted: March 4, 2015
• First Submitted That Met QC Criteria: March 10, 2015
• First Posted (Estimate): March 17, 2015

Study Record Updates

• Last Update Posted (Actual): October 2, 2017
• Last Update Submitted That Met QC Criteria: September 29, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Stroke; Spasticity; Botulinum Toxin type A; Dysport
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Hypertonia; Muscle Spasticity
• Other Study ID Numbers: A-38-52120-202