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: Completed
• Conditions: Spasticity

• Study Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• Italy
  • Milano, Italy, 20132
    • Ubaldo Del Carro
  • Milano, Italy, 80131
    • Marecello Esposito
  • Roma, Italy, 00189
    • Morena Giovannelli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with upper and/or lower limb spasticity

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?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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	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)
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)
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)
Occurrence of treatment discontinuation		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	From the baseline to the end of the study (12 months)

Collaborators and Investigators

• Sponsor: Ipsen

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2020
• Primary Completion (Actual): October 31, 2021
• Study Completion (Actual): October 31, 2021

Study Registration Dates

• First Submitted: April 8, 2020
• First Submitted That Met QC Criteria: April 8, 2020
• First Posted (Actual): April 9, 2020

Study Record Updates

• Last Update Posted (Actual): March 16, 2022
• Last Update Submitted That Met QC Criteria: March 15, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Hypertonia; Muscle Spasticity
• Other Study ID Numbers: A-IT-52120-264

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No