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

NCT ID: NCT02390206

Last Updated: 2017-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

239 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-06-30

Study Completion Date

2017-08-28

Brief Summary

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

Detailed Description

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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.

Conditions

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Spasticity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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).

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ipsen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ipsen Study Director

Role: STUDY_DIRECTOR

Ipsen

Locations

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Hospital Bettina Ferro de Souza Campus IV da Universidade Federal do Pará

Belém, , Brazil

Site Status

Centro Catarinense de Reabilitação

Florianópolis, , Brazil

Site Status

Centro de Reabilitação e Readaptação Dr. Henrique Santillo

Goiânia, , Brazil

Site Status

Clinica Neurológica e Neurocirúrgica de Joinville

Joinville, , Brazil

Site Status

Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto

Ribeirão Preto, , Brazil

Site Status

Hospital Universitário Clementino Fraga Filho (HUCFF)

Rio de Janeiro, , Brazil

Site Status

Instituto de Reabilitação Lucy Montoro - FAMERP

São José do Rio Preto, , Brazil

Site Status

Irmandade da Santa Casa de Misericórida de São Paulo

São Paulo, , Brazil

Site Status

Hospital Alemão Oswaldo Cruz

São Paulo, , Brazil

Site Status

Hospital São Paulo - UNIFESP

São Paulo, , Brazil

Site Status

HCSP - Complexo Hospital das Clinicas Instituto de Medicina Fisica e Reabilitação

São Paulo, , Brazil

Site Status

Countries

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Brazil

Other Identifiers

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A-38-52120-202

Identifier Type: -

Identifier Source: org_study_id