Last updated: 11/14/2025 13:30:13

Safety and Efficacy of high dose of OnabotulinumtoxinA (BoNT/A) for Treatment for Upper and Lower Limb Spasticity: An Observational Study in Japan

GSK study ID
220102
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Recruitment complete
Recruitment complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Safety and Efficacy of High Dose of Onabotulinumtoxin A (BoNT/A) for Treatment for Upper and Lower limb Spasticity: An Observational Study in Japan
Trial description: This is a multi-center, prospective, observational, single-arm study in Japan to evaluate the safety and efficacy of onabotulinumtoxinA during an observational period of one year (48 weeks) in adult patients (aged 15 years and older) who receive greater than (>) 400 to less than or equal to (≤) 600 units of onabotulinumtoxinA for simultaneous treatment of upper and lower limb spasticity and describe the utilization of step-up dose of onabotulinumtoxinA in real-world clinical settings.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Number and percentage of participants with adverse events (AEs), serious adverse events (SAEs) and adverse drug reactions (ADRs)

Timeframe: Up to 50 weeks

Number and percentage of participants with AEs leading to withdrawal from study

Timeframe: Up to 50 weeks

Number and percentage of participants with AEs leading to decrease onabotulinumtoxinA dose

Timeframe: Up to 50 weeks

Number and percentage of participants with AEs by severity

Timeframe: Up to 50 weeks

Number and percentage of participants with AEs/ADRs of major interest during the observational period

Timeframe: Up to 50 weeks

The frequency and percentage of participants with AEs and ADRs during the observational period for the participant background, dosage, and treatment session

Timeframe: Up to 50 weeks

Change of Percutaneous oxygen saturation (SpO2) between pre- and post-treatment measured at individual treatment session

Timeframe: Baseline (Week 0) , At week 6

The frequency and percentage of participants who take neutralizing antibody test and positive results of neutralizing antibody test

Timeframe: Up to 50 weeks

Secondary outcomes:

Number and percentage of participants for doses by treatment session (in whole body)

Timeframe: Up to 50 weeks

Number and percentage of participants for doses during the observational period (in whole body, limb, joint, muscle)

Timeframe: Up to 50 weeks

Number of injection sites by muscle

Timeframe: Up to 50 weeks

Number of injections by treatment session

Timeframe: Up to 50 weeks

Number of treatment intervals between sessions during the observational period

Timeframe: Up to 50 weeks

Number of participants for treatment patterns for dilution (volume of saline per 100-unit vial)

Timeframe: Up to 50 weeks

Frequency and percentage of participants with current medications during the observation period

Timeframe: Up to 50 weeks

Frequency and percentage of participants with concomitant therapies during the observation period

Timeframe: Up to 50 weeks

Change of Modified Ashworth Scale (MAS) between pre- and post-treatment measured at individual treatment session

Timeframe: Baseline, At week 6

Clinical Global Impression of Change (CGI-C) between pre- and post-treatment measured at individual treatment session

Timeframe: Baseline and up to 50 weeks

Patient-reported satisfaction with onabotulinumtoxinA per treatment session

Timeframe: Up to 50 weeks

Physician-reported satisfaction with onabotulinumtoxinA per treatment session

Timeframe: Up to 50 weeks

Interventions:
  • Drug: OnabotulinumtoxinA
    • Enrollment:
    100
    Primary completion date:
    2025-28-02
    Observational study model:
    Cohort
    Time perspective:
    Prospective
    Clinical publications:
    Not applicable
    Medical condition
    Spasticity, Post-Stroke
    Product
    OnabotulinumtoxinA
    Collaborators
    Not applicable
    Study date(s)
    May 2023 to December 2025
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    15+ years
    Accepts healthy volunteers
    No
    • Participants 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:
    • Participants 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
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Participants 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. Participants who will receive their first step-up dose (> 400 to ≤600 units per treatment session) B. Participants 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 safety efficacy, and participant background of the first step-up dose (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. Participant 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:
    • Participants 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

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    No study documents available.

    Results overview

    No study documents available

    Recruitment status
    Recruitment complete
    Actual primary completion date
    2025-28-02
    Actual study completion date
    Not applicable

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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