- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04340336
Study Assessing Adult Subjects Affected With Upper and/or Lower Limb Spasticity Treated With Botulinum Neurotoxin Type A (RESULT)
A Retrospective Multicenter Study Assessing Adult Subjects Affected With Upper and/or Lower Limb Spasticity Treated With Botulinum Neurotoxin Type A (Result Study)
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 Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Milano, Italy, 20132
- Ubaldo Del Carro
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Milano, Italy, 80131
- Marecello Esposito
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Roma, Italy, 00189
- Morena Giovannelli
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Average total dose of BoNT-A
Time Frame: From the baseline to the end of the study (12 months)
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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)
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From the baseline to the end of the study (12 months)
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Average interval between BoNT-A injections
Time Frame: From the baseline to the end of the study (12 months)
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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
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From the baseline to the end of the study (12 months)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Average total dose per BoNT-A type in upper limbs
Time Frame: From the baseline to the end of the study (12 months)
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Average total dose per BoNT-A type in upper limbs in patients treated for upper and lower limbs
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From the baseline to the end of the study (12 months)
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Average total dose per BoNT-A type in lower limbs
Time Frame: From the baseline to the end of the study (12 months)
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Average total dose per BoNT-A type in lower limbs in patients treated for upper and lower limbs
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From the baseline to the end of the study (12 months)
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Number of BoNT-A injection cycles
Time Frame: From the baseline to the end of the study (12 months)
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From the baseline to the end of the study (12 months)
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Average total dose per muscle in upper limbs
Time Frame: From the baseline to the end of the study (12 months)
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From the baseline to the end of the study (12 months)
|
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Average total dose per muscle in lower limbs
Time Frame: From the baseline to the end of the study (12 months)
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From the baseline to the end of the study (12 months)
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Number of switches between BoNT-A preparations
Time Frame: From the baseline to the end of the study (12 months)
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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
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From the baseline to the end of the study (12 months)
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Reason for injection
Time Frame: 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
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From the baseline to the end of the study (12 months)
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Reason for interruption
Time Frame: From the baseline to the end of the study (12 months)
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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
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From the baseline to the end of the study (12 months)
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Occurrence of treatment discontinuation
Time Frame: From the baseline to the end of the study (12 months)
|
From the baseline to the end of the study (12 months)
|
|
Global Treatment Satisfaction (GTS)
Time Frame: From the baseline to the end of the study (12 months)
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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
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From the baseline to the end of the study (12 months)
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- A-IT-52120-264
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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