POSITIVE study

JRCT ID: jRCT1031230129

Registered date:12/06/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: upper and lower limb spasticity
• Date of first enrollment: 12/06/2023
• Target sample size: 100
• Study type: Observational

Outcome(s)

• Primary Outcome: 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 Outcome

-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

Key inclusion & exclusion criteria

• Age minimum: >= 15age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Ai Hayashi