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Safety and efficacy of step-up dose onabotulinumtoxinA in the treatment of upper and lower limb spasticity: an observational study in Japan

POSITIVE study

Naho Oyanagi

GlaxoSmithKline K.K.

Akasaka Intercity AIR, 1-8-1 Akasaka, Minato-ku, Tokyo, Japan

botox_totaldoseup@mebix.co.jp

Yoshiyuki Matsuzaki

Mebix Inc

Toranomon 33 Mori Building 10F, 3-8-21 Toranomon, Minato-ku, Tokyo

+81-3-4362-4504

botox_totaldoseup@mebix.co.jp

Complete

June. 12, 2023

Observational

-Aged 15 years or older at the time of their informed consent
-Patients with upper and lower limb spasticity
-Planned to receive their first step-up dose injection of onabotulinumtoxinA (> 400 to <-600 units per treatment session) at their regular clinical treatment. This includes the following groups:
A. Patients who will receive their first step-up dose (> 400 to <-600 units per treatment session)
B. Patients who have received their first step-up dose (> 400 to <-600 units per treatment session) and are waiting for their second step-up dose
-The group (B) should meet the criteria below:
-First step-up dose of onabotulinumtoxinA occurred after Nov 2nd, 2022
-The treatment information of first step-up dose of onabotulinumtoxinA (e.g., dose and injection muscles) is available
-Possible to evaluate the safety1), efficacy2), and patient background3)of the first step-up dose (e.g, availability of medical records)
1. Safety outcomes: variables of AEs
2. Efficacy outcomes: variables of patient-reported satisfaction with onabotulinumtoxinA, and physician-reported satisfaction with onabotulinumtoxinA
3. Patient background: all variables (Exception: Regarding height and weight, the measurement at second step-up dose could be substituted if no data available at baseline)
-Willing and able to provide informed consent to participate in this study for 48 weeks
-Having the cognitive and linguistic ability to complete the study questionnaire

-Patients who received 2 or more times of step-up dose onabotulinumtoxinA (> 400 to <-600 units per treatment session)
-Having a condition or situation that would interfere significantly with the conduct of the study, as determined by the physicians/investigators
-Actively participating, or planning to participate in any other interventional clinical study

Both

upper and lower limb spasticity

D009128

To evaluate the efficacy of step-up dose onabotulinumtoxinA (> 400 to <-600 units per treatment session) in patients with upper and lower limb spasticity

-To evaluate the treatment patterns of step-up dose onabotulinumtoxinA (> 400 to <-600 units per treatment session) in patients with upper and lower limb spasticity
-To evaluate the efficacy of step-up dose onabotulinumtoxinA (> 400 to <-600 units per treatment session) in patients with upper and lower limb spasticity

+81-70-5011-8550

April. 19, 2023

No

none