Efficacy and Safety of Two Different Botulinum Toxin Type A Treatments for Moderate to Severe Cervical Dystonia
14. november 2011 opdateret af: Allergan
The purpose of this study is to compare two types of botulinum toxin type A to treat the involuntary muscle contractions in the neck
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
54
Fase
- Fase 4
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Buenos Aires, Argentina
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Victoria
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Parkville, Victoria, Australien
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New Delhi, Indien
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 75 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Diagnosed with cervical dystonia/spasmodic torticollis for at least 18 months
- Successfully treated previously with botulinum toxin type A
Exclusion Criteria:
- Breast feeding, pregnant, or could become pregnant
- Surgery or spinal cord stimulation for cervical dystonia
- Previous injections of phenol, alcohol for cervical dystonia
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: BOTOX®
Botulinum toxin type A (BOTOX®)
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200 enheder ved besøg 1 (dag 1)
Andre navne:
500 Units at Visit 1 (Day 1)
Andre navne:
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Aktiv komparator: Dysport®
Botulinum toxin type A (Dysport®)
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200 enheder ved besøg 1 (dag 1)
Andre navne:
500 Units at Visit 1 (Day 1)
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Duration of Treatment Benefit
Tidsramme: 20 Weeks
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Duration of treatment benefit was measured as the time (days) from Baseline until patients had a loss of therapeutic benefit, as defined by the achievement of their Toronto Western Spasmodic Torticollis Rating Scale Duration Target Score (TDTS) [loss of 80% of benefit].
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20 Weeks
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Patient visuel analog vurdering af smerte i uge 4
Tidsramme: Baseline, uge 4
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Patienterne skulle vurdere deres smerte ved hjælp af en visuel analog skala i forhold til deres nuværende smerteopfattelse ved det besøg.
Denne skala bestod af en streg, der målte 100 mm, og patienterne blev bedt om at sætte et mærke på stregen på det punkt, der bedst beskrev 'Hvor ondt har du lige nu'.
Højere score betegnede højere smerteintensitet: 0 angav 'Ingen smerte' og 100 angav 'Værst mulig smerte'.
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Baseline, uge 4
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Toronto Western Spasmodic Torticollis Rating Scale Duration Target Score (TDTS) at Week 4
Tidsramme: Week 4
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The TDTS was the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) score representing a loss of 80% of the treatment benefit at Week 4. The TDTS is calculated from the TWSTRS score and ranges from 0 (least symptoms) to 68 (worst symptoms).
The TWSTRS total score which is scored from 0 (least symptoms) to 85 (worst symptoms).
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Week 4
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Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score at Week 4
Tidsramme: Baseline, Week 4
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The TWSTRS is an assessment scale used to measure the impact of cervical dystonia on patients.
The score is comprised of 3 subscales: Severity, Disability, and Pain, each of which is scored independently.
The total of these 3 comprises the TWSTRS total score which is scored from 0 (least symptoms) to 85 (worst symptoms).
Higher scores indicate a greater degree of symptom severity.
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Baseline, Week 4
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Global Assessment of Benefit by Patient at Week 4
Tidsramme: Week 4
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Patient evaluation of benefit from botulinum toxin type A treatment for cervical dystonia.
Ratings were on a scale of +4 to -4, with higher scores denoting improvement in cervical dystonia: +4 was 'Complete abolishment of signs and symptoms (about 100% improvement)', 0 represented 'Unchanged', and -4 represented 'Very marked worsening (about 100% worse or greater)'.
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Week 4
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Global Assessment of Benefit by Physician at Week 4
Tidsramme: Week 4
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Physician evaluation of benefit from botulinum toxin type A treatment for cervical dystonia.
Ratings were on a scale of +4 to -4, with higher scores denoting improvement in cervical dystonia: +4 was 'Complete abolishment of signs and symptoms (about 100% improvement)', 0 represented 'Unchanged', and -4 represented 'Very marked worsening (about 100% worse or greater)'.
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Week 4
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Physician Assessment of Cervical Dystonia Severity at Week 4
Tidsramme: Baseline, Week 4
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Physician assessment of cervical dystonia severity.
The rating was assessed on a scale of 0 to 10, with higher scores denoting greater severity: 0 represented 'No evidence of dystonia' and 10 represented 'Worst cervical dystonia ever'
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Baseline, Week 4
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Physician Comparison of Benefit to Previous Injections at Week 20
Tidsramme: Week 20
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Physicians assessed the improvement in cervical dystonia after the study treatment compared to previous treatment(s) for each patient.
Physicians were required to answer "How would you rate the benefit of the current treatment of cervical dystonia with botulinum toxin type A compared to the previous treatment using the following scale?".
The response options were 'much worse', 'worse', 'somewhat worse', 'same as previous', 'somewhat better', 'better', and 'much better'.
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Week 20
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Patient Comparison of Benefit to Previous Injections at Week 20
Tidsramme: Week 20
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Patients assessed the improvement in cervical dystonia after receiving the study treatment compared to previous treatment(s).
Patients were required to answer "How would you rate the benefit of the current treatment of cervical dystonia with botulinum toxin type A compared to the previous treatment using the following scale?".
The response options were 'much worse', 'worse', 'somewhat worse', 'same as previous', 'somewhat better', 'better', and 'much better'.
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Week 20
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Patient Assessment of Need for Retreatment at Week 4
Tidsramme: Baseline, Week 4
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Patients were queried regarding their need for another injection of botulinum toxin type A for cervical dystonia.
Patients were required to answer "How would you rate your need for another injection of botulinum toxin type A for cervical dystonia using the following scale?".
The response options included 'absolutely requires injection', 'very much requires injection', 'somewhat requires injection', and 'does not require injection'.
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Baseline, Week 4
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. juni 2007
Primær færdiggørelse (Faktiske)
1. marts 2009
Studieafslutning (Faktiske)
1. juni 2009
Datoer for studieregistrering
Først indsendt
5. februar 2007
Først indsendt, der opfyldte QC-kriterier
5. februar 2007
Først opslået (Skøn)
7. februar 2007
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
16. december 2011
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
14. november 2011
Sidst verificeret
1. november 2011
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Neurologiske manifestationer
- Dyskinesier
- Dystoni
- Torticollis
- Lægemidlers fysiologiske virkninger
- Neurotransmittermidler
- Molekylære mekanismer for farmakologisk virkning
- Agenter fra det perifere nervesystem
- Kolinerge midler
- Membrantransportmodulatorer
- Acetylcholin-frigivelseshæmmere
- Neuromuskulære midler
- Botulinum toksiner
- Botulinumtoksiner, type A
- abobotulinumtoxinA
Andre undersøgelses-id-numre
- MedAff-BTX-0615
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .