POSITIVE study

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT1031230129

Enrollment

100

Registered

2023-06-12

Start date

2023-05-23

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

upper and lower limb spasticity

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -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 400 to 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

Exclusion criteria

Exclusion criteria: -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

Design outcomes

Primary

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

Secondary

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

Contacts

Public ContactMatsuzaki Yoshiyuki

Mebix Inc

botox_totaldoseup@mebix.co.jp+81-3-4362-4504

Outcome results