CD-PROBE: Cervical Dystonia Patient Registry for the Observation of onabotulinumtoxinA Efficacy
19. juni 2014 oppdatert av: Allergan
This study is an observational trial which will measure the efficacy of onabotulinumtoxinA in treating Cervical Dystonia.
Studieoversikt
Studietype
Observasjonsmessig
Registrering (Faktiske)
1046
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Massachusetts
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Springfield, Massachusetts, Forente stater
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Patients with Cervical Dystonia whom are being treated with onabotulinumtoxinA
Beskrivelse
Inclusion Criteria:
- Diagnosed with Cervical Dystonia
- Candidate for botulinum toxin type A therapy
- New to physician's practice, and/or new to botulinum toxin type A therapy, or has not been injected with botulinum toxin type A for at least 16 weeks as a participant in another clinical trial investigating botulinum toxin type A for cervical dystonia
- Able to follow study instructions and complete study activities
Exclusion Criteria:
- Patients undergoing elective surgery during the trial period
- Females who are pregnant, nursing, or planning a pregnancy
- History of poor cooperation or compliance with medical treatment or unreliability
- Any condition or situation in which, in the investigator's opinion, places the patient at significant risk, could confound the study data, or may interfere with the patient's participation in the study, including but not limited to unstable medical conditions
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Bare etui
- Tidsperspektiver: Potensielle
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
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BOTOX®
Patients received BOTOX® (onabotulinumtoxinA) treatment as standard of care in clinical practice as prescribed by the physician.
No intervention was administered as part of the study.
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No intervention was administered as part of the study.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score
Tidsramme: 4-6 weeks after treatment 3 (Up to 104.3 weeks)
|
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 subscales 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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4-6 weeks after treatment 3 (Up to 104.3 weeks)
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Percentage of Participants With Cervical Dystonia (CD) Severity Mild
Tidsramme: Baseline, 4-6 weeks after treatment 3 (Up to 104.3 weeks)
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The physician assessed the patient's severity of CD using a 3-point scale: mild, moderate or severe.
The percentage of participants with CD Severity Mild is reported.
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Baseline, 4-6 weeks after treatment 3 (Up to 104.3 weeks)
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Percentage of Participants With Improvement in Clinicians Global Impression of Change
Tidsramme: Baseline, 4-6 weeks after treatment 3 (Up to 104.3 weeks)
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The physician evaluated the change in the patient's present condition compared to Baseline using a 7-point scale where: 1= very much improved to 7= very much worse.
The percentage of participants where the physician's response was: 1=very much improved, 2=much improved or 3=minimally improved is reported.
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Baseline, 4-6 weeks after treatment 3 (Up to 104.3 weeks)
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Percentage of Participants With Improvement in the Patient Global Impression of Change
Tidsramme: Baseline, 4-6 weeks after treatment 3 (Up to 104.3 weeks)
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The patient evaluated the change in their present condition compared to Baseline using a 7-point scale where: 1= very much improved to 7= very much worse.
The percentage of participants with responses: 1=very much improved, 2=much improved or 3=minimally improved is reported.
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Baseline, 4-6 weeks after treatment 3 (Up to 104.3 weeks)
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Pain Numeric Rating Scale Score
Tidsramme: Baseline, 4-6 weeks after treatment 3 (Up to 104.3 weeks)
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Patients rated their level of pain during the past 24 hours using an 11-point scale where: 0=no pain to 10= pain as bad as you can imagine.
A lower number score indicated a lower amount of pain.
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Baseline, 4-6 weeks after treatment 3 (Up to 104.3 weeks)
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Agarwal P, Barbano R, Moore H, Schwartz M, Zuzek A, Sadeghi M, Patel A. OnabotulinumtoxinA Dosing, Disease Severity, and Treatment Benefit in Patients With Cervical Dystonia: A Cohort Analysis From CD PROBE. Front Neurol. 2022 Jun 30;13:914486. doi: 10.3389/fneur.2022.914486. eCollection 2022.
- Molho ES, Stacy M, Gillard P, Charles D, Adler CH, Jankovic J, Schwartz M, Brin MF. Impact of Cervical Dystonia on Work Productivity: An Analysis From a Patient Registry. Mov Disord Clin Pract. 2016 Mar-Apr;3(2):130-138. doi: 10.1002/mdc3.12238. Epub 2015 Dec 16.
- Jankovic J, Adler CH, Charles D, Comella C, Stacy M, Schwartz M, Manack Adams A, Brin MF. Primary results from the cervical dystonia patient registry for observation of onabotulinumtoxina efficacy (CD PROBE). J Neurol Sci. 2015 Feb 15;349(1-2):84-93. doi: 10.1016/j.jns.2014.12.030. Epub 2014 Dec 27.
- Jankovic J, Adler CH, Charles PD, Comella C, Stacy M, Schwartz M, Sutch SM, Brin MF, Papapetropoulos S. Rationale and design of a prospective study: Cervical Dystonia Patient Registry for Observation of OnaBotulinumtoxinA Efficacy (CD PROBE). BMC Neurol. 2011 Nov 4;11:140. doi: 10.1186/1471-2377-11-140.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. januar 2009
Primær fullføring (Faktiske)
1. august 2013
Studiet fullført (Faktiske)
1. august 2013
Datoer for studieregistrering
Først innsendt
2. februar 2009
Først innsendt som oppfylte QC-kriteriene
3. februar 2009
Først lagt ut (Anslag)
4. februar 2009
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
17. juli 2014
Siste oppdatering sendt inn som oppfylte QC-kriteriene
19. juni 2014
Sist bekreftet
1. juni 2014
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- MedAff BTX-0718
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