A Study to Assess Treatment Outcomes of abobotulinumtoxinA and onabotulinumtoxinA Treatments in Real Life Practice in Toxin-naïve Adult Patients With Limb Spasticity.
20 maggio 2021 aggiornato da: 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).
Panoramica dello studio
Stato
Completato
Tipo di studio
Osservativo
Iscrizione (Effettivo)
114
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Stafford, Regno Unito, ST6 7AG
- North Staffordshire Rehabilitation Centre. Midlands Partnership NHS Foundation Trust.
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Metodo di campionamento
Campione di probabilità
Popolazione di studio
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.
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: Coorte
- Prospettive temporali: Retrospettiva
Coorti e interventi
Gruppo / 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Average Goal Attainment Scale (GAS T) score 6 weeks
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 6 weeks
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6 weeks
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Average total dose
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
11 gennaio 2021
Completamento primario (Effettivo)
30 marzo 2021
Completamento dello studio (Effettivo)
30 marzo 2021
Date di iscrizione allo studio
Primo inviato
5 maggio 2020
Primo inviato che soddisfa i criteri di controllo qualità
18 maggio 2020
Primo Inserito (Effettivo)
20 maggio 2020
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
21 maggio 2021
Ultimo aggiornamento inviato che soddisfa i criteri QC
20 maggio 2021
Ultimo verificato
1 maggio 2021
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- F-GB-52120-268
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .