POSITIVE study

Not Applicable

• Conditions: upper and lower limb spasticity; D009128

• Registration Number: JPRN-jRCT1031230129
• Lead Sponsor: Ai Hayashi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-12
• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

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 <-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

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

Study & Design

• Study Type: Observational
• Study Design: Not specified