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

NCT04340336 | Completed

• 1 other identifier: A-IT-52120-264
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 3

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.

Conditions

Spasticity

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• Average total dose per BoNT-A type in upper limbs

  From the baseline to the end of the study (12 months)

• Average total dose per BoNT-A type in 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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with upper and/or lower limb spasticity

You may qualify if:

• 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

You may not qualify if:

• Treatments and assessments were performed at more than one centre

Sponsors & Collaborators

• Ipsen: lead

Study Sites (3)

Ubaldo Del Carro

Milan, 20132, Italy

Location

Marecello Esposito

Milan, 80131, Italy

Location

Morena Giovannelli

Roma, 00189, Italy

Location

MeSH Terms

Conditions

Muscle Spasticity

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ipsen Medical Director

  Ipsen

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2020
• First Posted: April 9, 2020
• Study Start: July 21, 2020
• Primary Completion: October 31, 2021
• Study Completion: October 31, 2021
• Last Updated: March 16, 2022

Record last verified: 2022-03

Locations

IT (3)