- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT04340336
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.
Studienübersicht
Status
Bedingungen
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
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Milano, Italien, 20132
- Ubaldo Del Carro
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Milano, Italien, 80131
- Marecello Esposito
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Roma, Italien, 00189
- Morena Giovannelli
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Average total dose of BoNT-A
Zeitfenster: From the baseline to the end of the study (12 months)
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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)
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From the baseline to the end of the study (12 months)
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Average interval between BoNT-A injections
Zeitfenster: From the baseline to the end of the study (12 months)
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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
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From the baseline to the end of the study (12 months)
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Average total dose per BoNT-A type in upper limbs
Zeitfenster: From the baseline to the end of the study (12 months)
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Average total dose per BoNT-A type in upper limbs in patients treated for upper and lower limbs
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From the baseline to the end of the study (12 months)
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Average total dose per BoNT-A type in lower limbs
Zeitfenster: 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
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From the baseline to the end of the study (12 months)
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Number of BoNT-A injection cycles
Zeitfenster: From the baseline to the end of the study (12 months)
|
From the baseline to the end of the study (12 months)
|
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Average total dose per muscle in upper limbs
Zeitfenster: From the baseline to the end of the study (12 months)
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From the baseline to the end of the study (12 months)
|
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Average total dose per muscle in lower limbs
Zeitfenster: From the baseline to the end of the study (12 months)
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From the baseline to the end of the study (12 months)
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Number of switches between BoNT-A preparations
Zeitfenster: From the baseline to the end of the study (12 months)
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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
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From the baseline to the end of the study (12 months)
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Reason for injection
Zeitfenster: From the baseline to the end of the study (12 months)
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Reported reason for injection at each cycle: due to medical need, scheduled visit, not recorded
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From the baseline to the end of the study (12 months)
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Reason for interruption
Zeitfenster: 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
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From the baseline to the end of the study (12 months)
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Occurrence of treatment discontinuation
Zeitfenster: From the baseline to the end of the study (12 months)
|
From the baseline to the end of the study (12 months)
|
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Global Treatment Satisfaction (GTS)
Zeitfenster: From the baseline to the end of the study (12 months)
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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
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From the baseline to the end of the study (12 months)
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Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- A-IT-52120-264
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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