A Study to Assess Treatment Outcomes of abobotulinumtoxinA and onabotulinumtoxinA Treatments in Real Life Practice in Toxin-naïve Adult Patients With Limb Spasticity.
20 de maio de 2021 atualizado por: Ipsen
A Single Centre, Non-interventional, Retrospective Study to Assess Treatment Outcomes of abobotulinumtoxinA and onabotulinumtoxinA Treatments in Real Life Practice in Toxin-naïve Adult Patients With Limb Spasticity.
The aim of the study is to describe treatment outcomes of abobotulinumtoxinA (aboBoNT-A) and onabotulinumtoxinA (onaBoNT-A) treatments, after one injection of either treatment, in toxin-naïve adult patients with upper and/or lower limb spasticity at a single National Health Service (NHS) centre in the United Kingdom (UK).
Visão geral do estudo
Status
Concluído
Tipo de estudo
Observacional
Inscrição (Real)
114
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Stafford, Reino Unido, ST6 7AG
- North Staffordshire Rehabilitation Centre. Midlands Partnership NHS Foundation Trust.
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Método de amostragem
Amostra de Probabilidade
População do estudo
All adult subjects with Upper Limb Spasticity and/or Lower Limb Spasticity complying with all inclusion and exclusion criteria during the study enrolment period will be included in this study.
This study is retrospective and non-interventional, and as such, subjects will have been treated in accordance with usual medical practice during the study period.
No additional assessments or tests will be required.
Descrição
Inclusion Criteria :
- Patient diagnosed with spasticity related to any cause except cerebral palsy.
- Patient initiated on treatment with either onaBoNT-A or aboBoNT-A during the study enrolment periods.
- Patient is an adult aged ≥18 years old at the time of the first BoNT-A injection for spasticity
- Patient has not received treatment with any type of BoNT-A 6 months prior to initiation of onaBoNT-A or aboBoNT-A. For patients with multiple courses of BoNT-A, separated by a gap of 6 months, only the first course will be evaluated in this study.
- Patient is being treated at Haywood Hospital at index date and during follow-up for up to 24 weeks post-index date, with medical records available for review.
Exclusion Criteria :
- Patient is participating in an interventional clinical trial of an investigational medicinal product for the treatment of spasticity at index date and/or during follow-up.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: Coorte
- Perspectivas de Tempo: Retrospectivo
Coortes e Intervenções
Grupo / Coorte |
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Botox
all eligible subjects, in a reverse consecutive order, initiated on onaBoNT-A from 01 March 2015 to 29 May 2017.
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Dysport
all subjects meeting inclusion/exclusion criteria and initiated on aboBoNT-A from 30 May 2017 to 30 March 2019.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Average Goal Attainment Scale (GAS T) score 6 weeks
Prazo: 6 weeks
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GAS, a method that evaluates the attainment of priority goals that are of importance to the patient and has been previously used for the management of patients with limb spasticity.
Rating is performed for each domain from -3 "worse than at start" to +2 "much more than expected: clear improvement".
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6 weeks
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Average Goal Attainment Scale (GAS T) score 12 weeks
Prazo: 12 weeks
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GAS, a method that evaluates the attainment of priority goals that are of importance to the patient and has been previously used for the management of patients with limb spasticity.
Rating is performed for each domain from -3 "worse than at start" to +2 "much more than expected: clear improvement".
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12 weeks
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Proportion of patients who achieve GAS-T score ≥0 for impairment/ symptoms goal
Prazo: 12 weeks
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12 weeks
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Proportion of patients who exceed GAS-T score ≥1 for impairment/ symptoms goal
Prazo: 6 weeks
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6 weeks
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Proportion of patients who exceed GAS-T score ≥1 for impairment/ symptoms goal
Prazo: 12 weeks
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12 weeks
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Proportion of patients who achieve GAS-T score ≥0 for impairment/ symptoms goal
Prazo: 6 weeks
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6 weeks
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Average total dose
Prazo: Day 0 (first BoNT-A injection) and from baseline up to 24 weeks (reinjection)
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Day 0 (first BoNT-A injection) and from baseline up to 24 weeks (reinjection)
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Average dose per limb and per type of muscle injected
Prazo: Day 0 (first BoNT-A injection) and from baseline up to 24 weeks (reinjection)
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Day 0 (first BoNT-A injection) and from baseline up to 24 weeks (reinjection)
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Distribution of vials used
Prazo: Day 0 (first BoNT-A injection) and from baseline up to 24 weeks (reinjection)
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If Dysport® 300U / 500U, if Botox® 50U / 100U / 200U
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Day 0 (first BoNT-A injection) and from baseline up to 24 weeks (reinjection)
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Distribution of localisation methods
Prazo: Day 0 (first BoNT-A injection) and from baseline up to 24 weeks (reinjection)
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Ultrasound, electrostimulation, palpation, electromyography
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Day 0 (first BoNT-A injection) and from baseline up to 24 weeks (reinjection)
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Distribution of limb and type of muscles injected
Prazo: Day 0 (first BoNT-A injection) and from baseline up to 24 weeks (reinjection)
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Upper limb: shoulder girdle, shoulder, arm, forearm, hand; lower limb: hip, thigh, leg and foot
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Day 0 (first BoNT-A injection) and from baseline up to 24 weeks (reinjection)
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Proportion of patients who require re-injection between aboBoNT-A and onaBoNT-A
Prazo: Week 6 and week 12 (re-injection)
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Week 6 and week 12 (re-injection)
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Quality of Life (QoL)
Prazo: From baseline up to 12 weeks
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The EQ-5D-VAS is used to evaluate patients' quality of life.
EQ-5D-VAS is one component of the EQ-5D-5L, a generic, preference-based measure of health-related quality of life.
The questions are answered based on how the subject is feeling "today".
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From baseline up to 12 weeks
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Average number of unscheduled visits
Prazo: From baseline up to end of the study (up to 24 weeks)
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From baseline up to end of the study (up to 24 weeks)
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Proportion of patients with ≥1 unscheduled visit
Prazo: From baseline up to end of the study (up to 24 weeks)
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From baseline up to end of the study (up to 24 weeks)
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Proportion of patients with at least "the same", or at least "better" satisfaction with their treatment as measured using a Likert scale
Prazo: From baseline up to 12 weeks
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A Likert scale is used to record patient's satisfaction with his/her progress, and the patient's "best response" (since index date) and "response now" (at the time of the review) on a five-category scale: From "Much worse" to "Much better"
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From baseline up to 12 weeks
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
11 de janeiro de 2021
Conclusão Primária (Real)
30 de março de 2021
Conclusão do estudo (Real)
30 de março de 2021
Datas de inscrição no estudo
Enviado pela primeira vez
5 de maio de 2020
Enviado pela primeira vez que atendeu aos critérios de CQ
18 de maio de 2020
Primeira postagem (Real)
20 de maio de 2020
Atualizações de registro de estudo
Última Atualização Postada (Real)
21 de maio de 2021
Última atualização enviada que atendeu aos critérios de controle de qualidade
20 de maio de 2021
Última verificação
1 de maio de 2021
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- F-GB-52120-268
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