A Study to Assess Treatment Outcomes of abobotulinumtoxinA and onabotulinumtoxinA Treatments in Real Life Practice in Toxin-naïve Adult Patients With Limb Spasticity.
20. Mai 2021 aktualisiert von: 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).
Studienübersicht
Status
Abgeschlossen
Studientyp
Beobachtungs
Einschreibung (Tatsächlich)
114
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Stafford, Vereinigtes Königreich, ST6 7AG
- North Staffordshire Rehabilitation Centre. Midlands Partnership NHS Foundation Trust.
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Probenahmeverfahren
Wahrscheinlichkeitsstichprobe
Studienpopulation
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.
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Beobachtungsmodelle: Kohorte
- Zeitperspektiven: Retrospektive
Kohorten und Interventionen
Gruppe / Kohorte |
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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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Average Goal Attainment Scale (GAS T) score 6 weeks
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 6 weeks
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6 weeks
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Average total dose
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
11. Januar 2021
Primärer Abschluss (Tatsächlich)
30. März 2021
Studienabschluss (Tatsächlich)
30. März 2021
Studienanmeldedaten
Zuerst eingereicht
5. Mai 2020
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
18. Mai 2020
Zuerst gepostet (Tatsächlich)
20. Mai 2020
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
21. Mai 2021
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
20. Mai 2021
Zuletzt verifiziert
1. Mai 2021
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- F-GB-52120-268
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