SpasticityRESULTNCT04340336
Study Assessing Adult Subjects Affected With Upper and/or Lower Limb Spasticity Treated With Botulinum Neurotoxin Type A
An observational study of Spasticity, run by Ipsen at 3 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spasticity
- How many people
- 150 participants
- Where
- 3 sitesItaly
- Study dates
- 21 Jul 2020to 31 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with upper and/or lower limb spasticity
Who may be able to join
- 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
Who cannot join
- Treatments and assessments were performed at more than one centre
Trial locations and contacts
3 sites in 1 country.
Italy3 sites
Ubaldo Del Carro
Milan, 20132
Marecello Esposito
Milan, 80131
Morena Giovannelli
Roma, 00189
About this study
Official title: 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.
- Conditions
- Spasticity
- Medical subject headings
- Muscle Spasticity
What is being measured
The primary outcome is the main question the study is designed to answer.
Average total dose of BoNT-A
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)
Measured: From the baseline to the end of the study (12 months)
Average interval between BoNT-A injections
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
Measured: From the baseline to the end of the study (12 months)
Secondary outcomes (10)
Average total dose per BoNT-A type in upper limbs
Average total dose per BoNT-A type in upper limbs in patients treated for upper and lower limbs
Measured: From the baseline to the end of the study (12 months)
Average total dose per BoNT-A type in lower limbs
Average total dose per BoNT-A type in lower limbs in patients treated for upper and lower limbs
Measured: From the baseline to the end of the study (12 months)
Number of BoNT-A injection cycles
Measured: From the baseline to the end of the study (12 months)
Average total dose per muscle in upper limbs
Measured: From the baseline to the end of the study (12 months)
Average total dose per muscle in lower limbs
Measured: From the baseline to the end of the study (12 months)
Number of switches between BoNT-A preparations
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
Measured: From the baseline to the end of the study (12 months)
Reason for injection
Reported reason for injection at each cycle: due to medical need, scheduled visit, not recorded
Measured: From the baseline to the end of the study (12 months)
Reason for interruption
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
Measured: From the baseline to the end of the study (12 months)
Occurrence of treatment discontinuation
Measured: From the baseline to the end of the study (12 months)
Global Treatment Satisfaction (GTS)
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
Measured: From the baseline to the end of the study (12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2020
- Study start21 Jul 2020
- Primary completion31 Oct 2021
- Study completion31 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpasticityStudies of the same condition, open and under way.
- More trials run by IpsenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04340336
- Sponsor's protocol ID
- A-IT-52120-264
- Acronym
- RESULT
- Status last verified
- Mar 2022
- First submitted
- 8 Apr 2020
- Last updated
- 16 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Multicenter Study Assessing Adult Subjects Affected With Upper and/or Lower Limb Spasticity Treated With Botulinum Neurotoxin Type A (Result Study)
- ClinicalTrials.gov ID
- NCT04340336
- Acronym / sponsor ID
- RESULT / A-IT-52120-264
- Conditions
- Spasticity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- 21 Jul 2020 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 31 Oct 2021 (actual)
- First posted
- 9 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with upper and/or lower limb spasticity
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Treatments and assessments were performed at more than one centre
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
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
10 secondary outcomes
Average total dose per BoNT-A type in upper limbs
Time frame: From the baseline to the end of the study (12 months)
Average total dose per BoNT-A type in lower limbs
Time frame: From the baseline to the end of the study (12 months)
Number of BoNT-A injection cycles
Time frame: From the baseline to the end of the study (12 months)
Average total dose per muscle in upper limbs
Time frame: From the baseline to the end of the study (12 months)
Average total dose per muscle in lower limbs
Time frame: From the baseline to the end of the study (12 months)
Number of switches between BoNT-A preparations
Time frame: From the baseline to the end of the study (12 months)
Reason for injection
Time frame: From the baseline to the end of the study (12 months)
Reason for interruption
Time frame: From the baseline to the end of the study (12 months)
Occurrence of treatment discontinuation
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ipsen Medical Director study director
Ipsen
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spasticity, run by Ipsen at 3 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average total dose of BoNT-A (time frame: From the baseline to the end of the study (12 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2022.