Clinical trial NCT04340336: Study Assessing Adult Subjects Affected With Upper and/or Lower Limb Spasticity Treated With Botulinum Neurotoxin Type A
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spasticity
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2020-04-09
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with upper and/or lower limb spasticity

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.


Eligibility criteria: 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

Primary outcomes:
measure: Average total dose of BoNT-A
timeFrame: From the baseline to the end of the study (12 months)
measure: Average interval between BoNT-A injections
timeFrame: From the baseline to the end of the study (12 months)
Secondary outcomes:
measure: Average total dose per BoNT-A type in upper limbs
timeFrame: From the baseline to the end of the study (12 months)
measure: Average total dose per BoNT-A type in lower limbs
timeFrame: From the baseline to the end of the study (12 months)
measure: Number of BoNT-A injection cycles
timeFrame: From the baseline to the end of the study (12 months)
measure: Average total dose per muscle in upper limbs
timeFrame: From the baseline to the end of the study (12 months)
measure: Average total dose per muscle in lower limbs
timeFrame: From the baseline to the end of the study (12 months)
measure: Number of switches between BoNT-A preparations
timeFrame: From the baseline to the end of the study (12 months)
measure: Reason for injection
timeFrame: From the baseline to the end of the study (12 months)
measure: Reason for interruption
timeFrame: From the baseline to the end of the study (12 months)
measure: Occurrence of treatment discontinuation
timeFrame: From the baseline to the end of the study (12 months)
measure: Global Treatment Satisfaction (GTS)
timeFrame: From the baseline to the end of the study (12 months)
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Ubaldo Del Carro
city: Milano
country: Italy
facility: Marecello Esposito
city: Roma
country: Italy
facility: Morena Giovannelli
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: