RESULT: Study Assessing Adult Subjects Affected With Upper and/or Lower Limb Spasticity Treated With Botulinum Neurotoxin Type A
Study Details
Study Description
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.
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Study Design
Outcome Measures
Primary Outcome Measures
- Average total dose of BoNT-A [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)
- Average interval between BoNT-A injections [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
Secondary Outcome Measures
- 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 upper limbs in patients treated for upper and lower limbs
- 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 BoNT-A type in lower limbs in patients treated for upper and lower limbs
- 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)]
- Average total dose per muscle in lower 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)]
Number of switches between BoNT-A preparations and reasons for switch (if known): due to no efficacy, persistent weak response in not fibrotic muscle, side effects, non-availability of the product
- Reason for injection [From the baseline to the end of the study (12 months)]
Reported reason for injection at each cycle: due to medical need, scheduled visit, not recorded
- Reason for interruption [From the baseline to the end of the study (12 months)]
Reported reason for BoNT-A interruptions (if applicable): side effects (excessive weakness, hematoma), no efficacy, fibrosis, contractures, long lasting clinical improvement, patients never showed up again
- 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)]
The qualitative subjective evaluation of patient treatment satisfaction has to be collected from medical records. The physician registered the level of satisfaction from previous treatment (very satisfied, satisfied, a little satisfied, not satisfied). A numerical value is assigned to each answer in order to obtain a numerical, subjective, GTS scale. It is a 4 point scale easy to use and to elaborate for analysis
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adult aged ≥18 years old at the time of the first BoNT-A injection
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Diagnosed with spasticity with any cause (excluded CP)
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Treated with a minimum of three BoNT-A treatment cycles for upper limb spasticity (ULS) and/or lower limb spasticity (LLS)
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With follow up data available in the subject's medical record
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ubaldo Del Carro | Milano | Italy | 20132 | |
| 2 | Marecello Esposito | Milano | Italy | 80131 | |
| 3 | Morena Giovannelli | Roma | Italy | 00189 |
Sponsors and Collaborators
- Ipsen
Investigators
- Study Director: Ipsen Medical Director, Ipsen
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- A-IT-52120-264