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

Completed

Phase N/A Results N/A

Update History

15 Jul '17
The gender criteria for eligibility was updated to "All."
A location was updated in Belém.
New
The overall status was removed for Hospital Bettina Ferro de Souza Campus IV da Universidade Federal do Pará.
A location was updated in Florianópolis.
New
The overall status was removed for Centro Catarinense de Reabilitação.
A location was updated in Goiânia.
New
The overall status was removed for Centro de Reabilitação e Readaptação Dr. Henrique Santillo.
A location was updated in Joinville.
New
The overall status was removed for Clinica Neurológica e Neurocirúrgica de Joinville.
A location was updated in Ribeirão Preto.
New
The overall status was removed for Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto.
A location was updated in Rio de Janeiro.
New
The overall status was removed for Hospital Universitário Clementino Fraga Filho (HUCFF).
A location was updated in São José do Rio Preto.
New
The overall status was removed for Instituto de Reabilitação Lucy Montoro - FAMERP.
A location was updated in São Paulo.
New
The overall status was removed for Hospital Alemão Oswaldo Cruz.
A location was updated in São Paulo.
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The overall status was removed for Hospital São Paulo - UNIFESP.
A location was updated in São Paulo.
New
The overall status was removed for HCSP - Complexo Hospital das Clinicas Instituto de Medicina Fisica e Reabilitação.
2 Apr '16
A location was updated in Belém.
New
The overall status was removed for Hospital Bettina Ferro de Souza Campus IV da Universidade Federal do Pará.
A location was updated in Florianópolis.
New
The overall status was removed for Centro Catarinense de Reabilitação.
A location was updated in Goiânia.
New
The overall status was removed for Centro de Reabilitação e Readaptação Dr. Henrique Santillo.
A location was updated in Ribeirão Preto.
New
The overall status was removed for Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto.
A location was updated in São Paulo.
New
The overall status was removed for Hospital Alemão Oswaldo Cruz.
A location was updated in São Paulo.
New
The overall status was removed for Hospital São Paulo - UNIFESP.
A location was updated in São Paulo.
New
The overall status was removed for HCSP - Complexo Hospital das Clinicas Instituto de Medicina Fisica e Reabilitação.
23 Dec '15
The eligibility criteria were updated.
New
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
Old
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 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
2 Sep '15
A location was updated in Curitiba.
New
The overall status was updated to "Withdrawn" at Hospital das Clínicas da Universidade Federal do Paraná.
A location was updated in Rio de Janeiro.
New
The overall status was removed for Hospital Universitário Clementino Fraga Filho (HUCFF).
2 Jul '15
The description was updated.
New
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.
Old
None.
A location was updated in Joinville.
New
The overall status was removed for Clinica Neurológica e Neurocirúrgica de Joinville.