A Retrospective Multicenter Study Assessing Adult Subjects Affected With Upper and/or Lower Limb Spasticity Treated With Botulinum Neurotoxin Type A (Result Study)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Ipsen
- Enrollment
- 150
- Locations
- 3
- Primary Endpoint
- Average interval between BoNT-A injections
Study Overview
Brief Summary
The aim of the study is to describe the long term use of Botulinum Neurotoxin Type A (BoNT-A) in adult subjects affected with upper and/or lower limb spasticity who received treatment with BoNT-A for a minimum of three injections cycles at three Italian centers.
The study has a retrospective design and data relating to subjects' injections cycles occurred in the past are collected. Period of observation defined in the protocol is from 2008 to 2018, but it could change for each subject according to the number of injections cycles performed. Time frame for data collection is 12 months from study start.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult aged ≥18 years old at the time of the first BoNT-A injection
- •Diagnosed with spasticity with any cause (excluded CP)
- •Treated with a minimum of three BoNT-A treatment cycles for upper limb spasticity (ULS) and/or lower limb spasticity (LLS)
- •With follow up data available in the subject's medical record
- •Provision of written informed consent form, to the extent required according to applicable national local regulations for a retrospective, non-interventional study
Exclusion Criteria
- •Treatments and assessments were performed at more than one centre
Outcomes
Primary Outcomes
Average interval between BoNT-A injections
Time Frame: From the baseline to the end of the study (12 months)
Average interval between BoNT-A injections in upper and/or lower limbs for BoNT-A overall (regardless of BoNT-A type) and per BoNT-A type
Average total dose of BoNT-A
Time Frame: From the baseline to the end of the study (12 months)
Average total dose per BoNT-A type in upper and/or lower limbs (this is the average total dose injected during all sessions per BoNT-A type during the study period)
Secondary Outcomes
- Average total dose per BoNT-A type in upper limbs(From the baseline to the end of the study (12 months))
- Average total dose per BoNT-A type in lower limbs(From the baseline to the end of the study (12 months))
- Average total dose per muscle in lower limbs(From the baseline to the end of the study (12 months))
- Occurrence of treatment discontinuation(From the baseline to the end of the study (12 months))
- Global Treatment Satisfaction (GTS)(From the baseline to the end of the study (12 months))
- Number of BoNT-A injection cycles(From the baseline to the end of the study (12 months))
- Average total dose per muscle in upper limbs(From the baseline to the end of the study (12 months))
- Number of switches between BoNT-A preparations(From the baseline to the end of the study (12 months))
- Reason for injection(From the baseline to the end of the study (12 months))
- Reason for interruption(From the baseline to the end of the study (12 months))