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 uppdaterad av: 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).
Studieöversikt
Status
Avslutad
Studietyp
Observationell
Inskrivning (Faktisk)
114
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Stafford, Storbritannien, ST6 7AG
- North Staffordshire Rehabilitation Centre. Midlands Partnership NHS Foundation Trust.
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Sannolikhetsprov
Studera befolkning
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.
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: Kohort
- Tidsperspektiv: Retrospektiv
Kohorter och interventioner
Grupp / Kohort |
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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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Average Goal Attainment Scale (GAS T) score 6 weeks
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 6 weeks
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6 weeks
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Average total dose
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
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Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
11 januari 2021
Primärt slutförande (Faktisk)
30 mars 2021
Avslutad studie (Faktisk)
30 mars 2021
Studieregistreringsdatum
Först inskickad
5 maj 2020
Först inskickad som uppfyllde QC-kriterierna
18 maj 2020
Första postat (Faktisk)
20 maj 2020
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
21 maj 2021
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
20 maj 2021
Senast verifierad
1 maj 2021
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- F-GB-52120-268
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