A Study to Assess Treatment Outcomes of abobotulinumtoxinA and onabotulinumtoxinA Treatments in Real Life Practice in Toxin-naïve Adult Patients With Limb Spasticity.
20. maj 2021 opdateret af: 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).
Studieoversigt
Status
Afsluttet
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
114
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Stafford, Det Forenede Kongerige, ST6 7AG
- North Staffordshire Rehabilitation Centre. Midlands Partnership NHS Foundation Trust.
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
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.
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kohorte
- Tidsperspektiver: Tilbagevirkende kraft
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
Botox
all eligible subjects, in a reverse consecutive order, initiated on onaBoNT-A from 01 March 2015 to 29 May 2017.
|
|
Dysport
all subjects meeting inclusion/exclusion criteria and initiated on aboBoNT-A from 30 May 2017 to 30 March 2019.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Average Goal Attainment Scale (GAS T) score 6 weeks
Tidsramme: 6 weeks
|
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".
|
6 weeks
|
|
Average Goal Attainment Scale (GAS T) score 12 weeks
Tidsramme: 12 weeks
|
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".
|
12 weeks
|
|
Proportion of patients who achieve GAS-T score ≥0 for impairment/ symptoms goal
Tidsramme: 12 weeks
|
12 weeks
|
|
|
Proportion of patients who exceed GAS-T score ≥1 for impairment/ symptoms goal
Tidsramme: 6 weeks
|
6 weeks
|
|
|
Proportion of patients who exceed GAS-T score ≥1 for impairment/ symptoms goal
Tidsramme: 12 weeks
|
12 weeks
|
|
|
Proportion of patients who achieve GAS-T score ≥0 for impairment/ symptoms goal
Tidsramme: 6 weeks
|
6 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Average total dose
Tidsramme: Day 0 (first BoNT-A injection) and from baseline up to 24 weeks (reinjection)
|
Day 0 (first BoNT-A injection) and from baseline up to 24 weeks (reinjection)
|
|
|
Average dose per limb and per type of muscle injected
Tidsramme: Day 0 (first BoNT-A injection) and from baseline up to 24 weeks (reinjection)
|
Day 0 (first BoNT-A injection) and from baseline up to 24 weeks (reinjection)
|
|
|
Distribution of vials used
Tidsramme: Day 0 (first BoNT-A injection) and from baseline up to 24 weeks (reinjection)
|
If Dysport® 300U / 500U, if Botox® 50U / 100U / 200U
|
Day 0 (first BoNT-A injection) and from baseline up to 24 weeks (reinjection)
|
|
Distribution of localisation methods
Tidsramme: Day 0 (first BoNT-A injection) and from baseline up to 24 weeks (reinjection)
|
Ultrasound, electrostimulation, palpation, electromyography
|
Day 0 (first BoNT-A injection) and from baseline up to 24 weeks (reinjection)
|
|
Distribution of limb and type of muscles injected
Tidsramme: Day 0 (first BoNT-A injection) and from baseline up to 24 weeks (reinjection)
|
Upper limb: shoulder girdle, shoulder, arm, forearm, hand; lower limb: hip, thigh, leg and foot
|
Day 0 (first BoNT-A injection) and from baseline up to 24 weeks (reinjection)
|
|
Proportion of patients who require re-injection between aboBoNT-A and onaBoNT-A
Tidsramme: Week 6 and week 12 (re-injection)
|
Week 6 and week 12 (re-injection)
|
|
|
Quality of Life (QoL)
Tidsramme: From baseline up to 12 weeks
|
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".
|
From baseline up to 12 weeks
|
|
Average number of unscheduled visits
Tidsramme: From baseline up to end of the study (up to 24 weeks)
|
From baseline up to end of the study (up to 24 weeks)
|
|
|
Proportion of patients with ≥1 unscheduled visit
Tidsramme: From baseline up to end of the study (up to 24 weeks)
|
From baseline up to end of the study (up to 24 weeks)
|
|
|
Proportion of patients with at least "the same", or at least "better" satisfaction with their treatment as measured using a Likert scale
Tidsramme: From baseline up to 12 weeks
|
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"
|
From baseline up to 12 weeks
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
11. januar 2021
Primær færdiggørelse (Faktiske)
30. marts 2021
Studieafslutning (Faktiske)
30. marts 2021
Datoer for studieregistrering
Først indsendt
5. maj 2020
Først indsendt, der opfyldte QC-kriterier
18. maj 2020
Først opslået (Faktiske)
20. maj 2020
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
21. maj 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
20. maj 2021
Sidst verificeret
1. maj 2021
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- F-GB-52120-268
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .