A Study to Assess Treatment Outcomes of abobotulinumtoxinA and onabotulinumtoxinA Treatments in Real Life Practice in Toxin-naïve Adult Patients With Limb Spasticity.
20 mei 2021 bijgewerkt door: 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).
Studie Overzicht
Toestand
Voltooid
Studietype
Observationeel
Inschrijving (Werkelijk)
114
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Stafford, Verenigd Koninkrijk, ST6 7AG
- North Staffordshire Rehabilitation Centre. Midlands Partnership NHS Foundation Trust.
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Bemonsteringsmethode
Kanssteekproef
Studie Bevolking
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.
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: Cohort
- Tijdsperspectieven: Retrospectief
Cohorten en interventies
Groep / Cohort |
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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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Average Goal Attainment Scale (GAS T) score 6 weeks
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 6 weeks
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6 weeks
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Average total dose
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
11 januari 2021
Primaire voltooiing (Werkelijk)
30 maart 2021
Studie voltooiing (Werkelijk)
30 maart 2021
Studieregistratiedata
Eerst ingediend
5 mei 2020
Eerst ingediend dat voldeed aan de QC-criteria
18 mei 2020
Eerst geplaatst (Werkelijk)
20 mei 2020
Updates van studierecords
Laatste update geplaatst (Werkelijk)
21 mei 2021
Laatste update ingediend die voldeed aan QC-criteria
20 mei 2021
Laatst geverifieerd
1 mei 2021
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- F-GB-52120-268
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