Study Assessing Adult Subjects Affected With Upper and/or Lower Limb Spasticity Treated With Botulinum Neurotoxin Type A

Spasticity Clinical Trial

— RESULT  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04340336
• Other study ID #: A-IT-52120-264
• Status: Completed
• Start date: July 21, 2020
• Est. completion date: October 31, 2021

Study information

• Verified date: March 2022
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: October 31, 2021
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Muscle Spasticity
• Spasticity

Locations

Country	Name	City	State
Italy	Marecello Esposito	Milano
Italy	Ubaldo Del Carro	Milano
Italy	Morena Giovannelli	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	From the baseline to the end of the study (12 months)
Primary	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	From the baseline to the end of the study (12 months)
Secondary	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	From the baseline to the end of the study (12 months)
Secondary	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	From the baseline to the end of the study (12 months)
Secondary	Number of BoNT-A injection cycles		From the baseline to the end of the study (12 months)
Secondary	Average total dose per muscle in upper limbs		From the baseline to the end of the study (12 months)
Secondary	Average total dose per muscle in lower limbs		From the baseline to the end of the study (12 months)
Secondary	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	From the baseline to the end of the study (12 months)
Secondary	Reason for injection	Reported reason for injection at each cycle: due to medical need, scheduled visit, not recorded	From the baseline to the end of the study (12 months)
Secondary	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	From the baseline to the end of the study (12 months)
Secondary	Occurrence of treatment discontinuation		From the baseline to the end of the study (12 months)
Secondary	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	From the baseline to the end of the study (12 months)