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Completed

NCT Number: NCT02390206

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

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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Change in Goal Achievement Score (GAS).

    Time frame: 3 and 6 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study 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

Acronym: B-CAUSE

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Mar 17, 2015
Registry last updated
Oct 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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