- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00819065
Trial Comparing Two Commercial Formulations of Botulinum Toxin Type A in the Treatment of Spasticity
6. Juli 2011 aktualisiert von: Hospital de Clinicas de Porto Alegre
Randomized Double-blind Clinical Trial Comparing Two Commercial Formulations of Botulinum Toxin Type A in the Treatment of Spasticity
The purpose of this study is to compare the effectiveness between two commercial formulations of botulinum toxin type A in the treatment of spasticity through the Ashworth scale.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Detaillierte Beschreibung
Botulinum toxin type A has been used clinically in spasticity treatment for over a decade.
There are, nowadays, three commercial formulations of BTA, wich, though the same type of toxin, are different biological products that differ about storage, dilution and dosage.
The units of one toxin are exclusive of that product, and an international standard-unit lacks.
Each kind of BTA has been through validation and safety studies, but there are very few comparative studies between them.
Thus, the purpose of this study is to compare the efficacy between two commercial formulations of BTA in the treatment of spasticity.
We will also evaluate the safety, adverse effects and cost of each formulation.
Will be included in this study patients currently in treatment with BTA/with indication for BTA treatment for spasticity, who must not have any contraindications for the drug, at the Spasticity outpatient clinic of the Hospital de Clínicas de Porto Alegre.
All patients included must agree to participate in the study by signing an informed consent form.Patients will be randomized into two groups of 28 individuals each (total of 56 patients) and will receive BTA from laboratory Allergan and Lanzhou, one at time of allocation and the other three months after, in a crossover model.
These drugs are both approved by ANVISA for the treatment of spasticity and provided by the national public health system (SUS).
Application will be performed by a trained investigator, unaware of the kind of BTA in use.
Standard dilutions of both toxins will be employed, within the usual dose and application spots (for patients already in treatment) or standard (for patients yet to start treatment).
Identical dose will be used, with 2ml of saline solution 0,9% dilution for each 100units, thus, there will be no difference for the patient or investigator concerning the applicated volume, assuring appropriate masking.
Follow-up visits will be performed after four, twelve, sixteen and twenty-four weeks, by investigator unaware of the kind of BTA in use.
The modified Ashworth Scale will be applied at every visit by three medical investigators isolatedly, duly trained and blinded to the intervention.
Life quality will be assessed at time of allocation, four and twelve weeks after, using WHOQOL-Bref, YQOL-R and Children's Life Quality Assessment Questionnaire, respecting the age of the patient.
Functional capability will also be evaluated, through the Functional Independence Measure Scale (FIM) for adults and PEDI scale for children, at the same time frames as the life quality assessment instruments.
The primary end-point consists on the maximum degree of effect assessed through passive measurement of muscular tonus and quantified by the modified Ashworth Scale.
Secondary end-points are presence, kind and duration of adverse effects of each treatment and perception of improvement of symptoms by the patient himself or caregiver.
Statistical analysis will be performed using the SPSS package for Windows and descriptive analysis will be provided by absolute and relative frequencies and average±standard deviation for quantitative variables and percentages for qualitative ones.
The T of Student or Mann-Whitney tests will be used for independent samples, and chi-square and Fischer's exact tests will be performed when necessary.
Significance level will be 5%.There will be no additional risk for the patients, since the drugs involved in this trial have already been tested individually for efficacy and safety and are currently being used in medical practice for the treatment of these conditions.
The Public Health State Secretariat will be responsible for providing the drugs, according to routine pharmaceutical assistance, and there will be no additional cost for the hospital nor health system.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
56
Phase
- Phase 3
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
Rio Grande do Sul
-
Porto Alegre, Rio Grande do Sul, Brasilien
- Hospital de Clínicas de Porto Alegre
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
2 Jahre und älter (Kind, Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
Inclusion Criteria:
- To be included, patients must have diagnosis of Spasticity by IC10 criteria.
- We will enroll patients on current treatment for spasticity at the Spasticity outpatient clinic of HCPA, already in treatment with BTA or starting that treatment based on their doctors' decision, who are willing to participate in the trial by signing an informed consent form.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Crossover-Aufgabe
- Maskierung: Vervierfachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Aktiver Komparator: 1-BTA Lanzhou/Allergan
Patients randomly allocated to this arm will receive botulinum toxin type A from laboratory Lanzhou at allocation and after twelve weeks will receive the same drug from laboratory Allergan.
|
Patients will receive botulinum toxin type A from laboratory Lanzhou either at time of allocation (arm BTA Lanzhou/Allergan) or three months later (arm BTA Allergan/Lanzhou), so that all patients will receive both drugs in a crossover model.
Application will be performed according to standard protocol and respecting parameters of the patients former sessions (if there were any), by a trained investigator, unaware of the kind of TBA in use.
Standard dilution will be employed, within the usual dose and application spots (for patients already in treatment) or standard (for patients yet to start treatment).
Identical dose will be used, with 2ml of saline solution 0,9% dilution for each 100units, thus, there will be no difference for the patient or investigator concerning the applicated volume.
Andere Namen:
Patients will receive botulinum toxin type A from laboratory Allergan either at time of allocation (arm BTA Allergan / Lanzhou) or three months later (arm BTA Lanzhou /Allergan), so that all patients will receive both drugs in a crossover model.
Application will be performed according to standard protocol and respecting parameters of the patients former sessions (if there were any), by a trained investigator, unaware of the kind of BTA in use.
Standard dilution will be employed, within the usual dose and application spots (for patients already in treatment) or standard (for patients yet to start treatment).
Identical dose will be used, with 2ml of saline solution 0,9% dilution for each 100units, thus, there will be no difference for the patient or investigator concerning the applicated volume.
Andere Namen:
|
Aktiver Komparator: 2. BTA Allergan/Lanzhou
Patients randomly allocated to this arm will receive botulinum toxin type A from laboratory Allergan at allocation and after twelve weeks will receive the same drug from laboratory Lanzhou.
|
Patients will receive botulinum toxin type A from laboratory Lanzhou either at time of allocation (arm BTA Lanzhou/Allergan) or three months later (arm BTA Allergan/Lanzhou), so that all patients will receive both drugs in a crossover model.
Application will be performed according to standard protocol and respecting parameters of the patients former sessions (if there were any), by a trained investigator, unaware of the kind of TBA in use.
Standard dilution will be employed, within the usual dose and application spots (for patients already in treatment) or standard (for patients yet to start treatment).
Identical dose will be used, with 2ml of saline solution 0,9% dilution for each 100units, thus, there will be no difference for the patient or investigator concerning the applicated volume.
Andere Namen:
Patients will receive botulinum toxin type A from laboratory Allergan either at time of allocation (arm BTA Allergan / Lanzhou) or three months later (arm BTA Lanzhou /Allergan), so that all patients will receive both drugs in a crossover model.
Application will be performed according to standard protocol and respecting parameters of the patients former sessions (if there were any), by a trained investigator, unaware of the kind of BTA in use.
Standard dilution will be employed, within the usual dose and application spots (for patients already in treatment) or standard (for patients yet to start treatment).
Identical dose will be used, with 2ml of saline solution 0,9% dilution for each 100units, thus, there will be no difference for the patient or investigator concerning the applicated volume.
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
Muscle tonus reduction will be assessed by the Ashworth Scale.
Zeitfenster: time of allocation, four, twelve, sixteen and twenty-four weeks after first application of toxin.
|
time of allocation, four, twelve, sixteen and twenty-four weeks after first application of toxin.
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
Life quality will be assessed by WHOQOL-Bref, YQOL-R and Children's Life Quality assessment questionnaire, respecting the age of the patient.
Zeitfenster: time of allocation, twelve and twenty-four weeks after first application of toxin.
|
time of allocation, twelve and twenty-four weeks after first application of toxin.
|
Functional capability will be evaluated through the Functional Independence Measure Scale (FIM) for adults and PEDI scale for children.
Zeitfenster: time of allocation, twelve and twenty-four weeks after first application of toxin.
|
time of allocation, twelve and twenty-four weeks after first application of toxin.
|
Incidence, severity and duration of adverse effects of each treatment, through adverse events scale.
Zeitfenster: every follow-up visit.
|
every follow-up visit.
|
Perception of improvement of the symptoms by the patient himself or caregiver.
Zeitfenster: every follow-up visit.
|
every follow-up visit.
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Ermittler
- Hauptermittler: Paulo D Picon, Hospital de Clínicas de Porto Alegre
- Studienstuhl: Fábio C Guarany, Hospital de Clínicas de Porto Alegre
- Studienleiter: Nicole Ruas, Hospital de Clínicas de Porto Alegre
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. März 2009
Primärer Abschluss (Tatsächlich)
1. Mai 2010
Studienabschluss (Tatsächlich)
1. Juni 2011
Studienanmeldedaten
Zuerst eingereicht
7. Januar 2009
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
7. Januar 2009
Zuerst gepostet (Schätzen)
8. Januar 2009
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
7. Juli 2011
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
6. Juli 2011
Zuletzt verifiziert
1. Juli 2011
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Erkrankungen des Nervensystems
- Neurologische Manifestationen
- Erkrankungen des Bewegungsapparates
- Muskelerkrankungen
- Neuromuskuläre Manifestationen
- Muskelhypertonie
- Muskelspastik
- Physiologische Wirkungen von Arzneimitteln
- Neurotransmitter-Agenten
- Molekulare Mechanismen der pharmakologischen Wirkung
- Agenten des peripheren Nervensystems
- Cholinerge Wirkstoffe
- Membrantransportmodulatoren
- Acetylcholinfreisetzungshemmer
- Neuromuskuläre Wirkstoffe
- Botulinumtoxine
- Botulinumtoxine, Typ A
- AbobotulinumtoxinA
Andere Studien-ID-Nummern
- 06336
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