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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02390206
Recruitment Status : Completed
First Posted : March 17, 2015
Last Update Posted : October 2, 2017
Sponsor:
Information provided by (Responsible Party):
Ipsen

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

Condition or disease
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 Design
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Study Type : Observational
Actual Enrollment : 239 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Study Start Date : June 2015
Actual Primary Completion Date : August 28, 2017
Actual Study Completion Date : August 28, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

Groups and Cohorts
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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).


Outcome Measures
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Primary Outcome Measures :
  1. Change in Goal Achievement Score (GAS). [ Time Frame: 3 and 6 months ]

Secondary Outcome Measures :
  1. Change from baseline in pain according to Verbal Numerical Scale (VNS). [ Time Frame: Baseline and 3 months ]
  2. Change from baseline in Modified Ashworth Scale (MAS) score [ Time Frame: Baseline and 3 months ]
  3. Change from baseline in functional independence according to Barthel index score [ Time Frame: Baseline and 3 months ]
  4. Change from baseline in Quality of Life according to Euro-5D-5L health questionnaire [ Time Frame: Baseline and 3 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Untreated chronic post-stroke spastic patients
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02390206


Locations
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Brazil
Hospital Bettina Ferro de Souza Campus IV da Universidade Federal do Pará
Belém, Brazil, 66045-110
Centro Catarinense de Reabilitação
Florianópolis, Brazil, 88025-301
Centro de Reabilitação e Readaptação Dr. Henrique Santillo
Goiânia, Brazil, 74653-230
Clinica Neurológica e Neurocirúrgica de Joinville
Joinville, Brazil, 89202-165
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
Ribeirão Preto, Brazil, 14048-900
Hospital Universitário Clementino Fraga Filho (HUCFF)
Rio de Janeiro, Brazil, 21941-913
Instituto de Reabilitação Lucy Montoro - FAMERP
São José do Rio Preto, Brazil, 1591-240
Irmandade da Santa Casa de Misericórida de São Paulo
São Paulo, Brazil, 01221-010
Hospital Alemão Oswaldo Cruz
São Paulo, Brazil, 01323-903
Hospital São Paulo - UNIFESP
São Paulo, Brazil, 04024-002
HCSP - Complexo Hospital das Clinicas Instituto de Medicina Fisica e Reabilitação
São Paulo, Brazil, 05403-900
Sponsors and Collaborators
Ipsen
Investigators
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Study Director: Ipsen Study Director Ipsen
More Information
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Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT02390206    
Other Study ID Numbers: A-38-52120-202
First Posted: March 17, 2015    Key Record Dates
Last Update Posted: October 2, 2017
Last Verified: September 2017
Keywords provided by Ipsen:
Stroke
Spasticity
Botulinum Toxin type A
Dysport
Additional relevant MeSH terms:
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Muscle Spasticity
Nervous System Diseases
Muscular Diseases
Musculoskeletal Diseases
 Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations