A Study to Assess Treatment Outcomes of abobotulinumtoxinA and onabotulinumtoxinA Treatments in Real Life Practice in Toxin-naïve Adult Patients With Limb Spasticity.
2021年5月20日 更新者：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).
調査の概要
状態
完了
研究の種類
観察的
入学 (実際)
114
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
-
Stafford、イギリス、ST6 7AG
- North Staffordshire Rehabilitation Centre. Midlands Partnership NHS Foundation Trust.
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
サンプリング方法
確率サンプル
調査対象母集団
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.
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：コホート
- 時間の展望：回顧
コホートと介入
グループ/コホート |
|---|
|
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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Average Goal Attainment Scale (GAS T) score 6 weeks
時間枠：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
時間枠：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
時間枠：12 weeks
|
12 weeks
|
|
|
Proportion of patients who exceed GAS-T score ≥1 for impairment/ symptoms goal
時間枠：6 weeks
|
6 weeks
|
|
|
Proportion of patients who exceed GAS-T score ≥1 for impairment/ symptoms goal
時間枠：12 weeks
|
12 weeks
|
|
|
Proportion of patients who achieve GAS-T score ≥0 for impairment/ symptoms goal
時間枠：6 weeks
|
6 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Average total dose
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：Week 6 and week 12 (re-injection)
|
Week 6 and week 12 (re-injection)
|
|
|
Quality of Life (QoL)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2021年1月11日
一次修了 (実際)
2021年3月30日
研究の完了 (実際)
2021年3月30日
試験登録日
最初に提出
2020年5月5日
QC基準を満たした最初の提出物
2020年5月18日
最初の投稿 (実際)
2020年5月20日
学習記録の更新
投稿された最後の更新 (実際)
2021年5月21日
QC基準を満たした最後の更新が送信されました
2021年5月20日
最終確認日
2021年5月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。