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Completed

NCT Number: NCT04340336

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Marecello Esposito, Milan, Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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)

  2. 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

Secondary outcomes

  1. 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 upper limbs in patients treated for upper and lower limbs

  2. Average total dose per BoNT-A type in lower limbs

    Time frame: From the baseline to the end of the study (12 months)

    Average total dose per BoNT-A type in lower limbs in patients treated for upper and lower limbs

  3. Number of BoNT-A injection cycles

    Time frame: From the baseline to the end of the study (12 months)

  4. Average total dose per muscle in upper limbs

    Time frame: From the baseline to the end of the study (12 months)

  5. Average total dose per muscle in lower limbs

    Time frame: From the baseline to the end of the study (12 months)

  6. Number of switches between BoNT-A preparations

    Time frame: From the baseline to the end of the study (12 months)

    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

  7. Reason for injection

    Time frame: From the baseline to the end of the study (12 months)

    Reported reason for injection at each cycle: due to medical need, scheduled visit, not recorded

  8. Reason for interruption

    Time frame: From the baseline to the end of the study (12 months)

    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

  9. Occurrence of treatment discontinuation

    Time frame: From the baseline to the end of the study (12 months)

  10. Global Treatment Satisfaction (GTS)

    Time frame: From the baseline to the end of the study (12 months)

    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

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study title

A Retrospective Multicenter Study Assessing Adult Subjects Affected With Upper and/or Lower Limb Spasticity Treated With Botulinum Neurotoxin Type A (Result Study)

Acronym: RESULT

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 9, 2020
Registry last updated
Mar 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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