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CD-PROBE: Cervical Dystonia Patient Registry for the Observation of onabotulinumtoxinA Efficacy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT00836017
First received: February 2, 2009
Last updated: June 19, 2014
Last verified: June 2014

February 2, 2009
June 19, 2014
January 2009
August 2013   (final data collection date for primary outcome measure)
Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score [ Time Frame: 4-6 weeks after treatment 3 (Up to 104.3 weeks) ] [ Designated as safety issue: No ]
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.
Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) [ Time Frame: Baseline, at time of injection 1, 2, 3, and 4-6 weeks after injection 3 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00836017 on ClinicalTrials.gov Archive Site
  • Percentage of Participants With Cervical Dystonia (CD) Severity Mild [ Time Frame: Baseline, 4-6 weeks after treatment 3 (Up to 104.3 weeks) ] [ Designated as safety issue: No ]
    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.
  • Percentage of Participants With Improvement in Clinicians Global Impression of Change [ Time Frame: Baseline, 4-6 weeks after treatment 3 (Up to 104.3 weeks) ] [ Designated as safety issue: No ]
    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.
  • Percentage of Participants With Improvement in the Patient Global Impression of Change [ Time Frame: Baseline, 4-6 weeks after treatment 3 (Up to 104.3 weeks) ] [ Designated as safety issue: No ]
    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.
  • Pain Numeric Rating Scale Score [ Time Frame: Baseline, 4-6 weeks after treatment 3 (Up to 104.3 weeks) ] [ Designated as safety issue: No ]
    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.
  • CD Severity [ Time Frame: Baseline, at time of injection 1, 2, 3, and 4-6 weeks after injection 3 ] [ Designated as safety issue: No ]
  • Clinicians Global Impression of Change [ Time Frame: At time of injection 2 and 3, and 4-6 weeks after injection 3 ] [ Designated as safety issue: No ]
  • Patient Global Impression of Change [ Time Frame: At time of injection 2 and 3, and 4-6 weeks after injections 1, 2, and 3 ] [ Designated as safety issue: No ]
  • Pain Numeric Rating Scale [ Time Frame: Baseline, at time of injection, 1, 2, 3 and 4-6 weeks after injections 1, 2 and 3 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
CD-PROBE: Cervical Dystonia Patient Registry for the Observation of onabotulinumtoxinA Efficacy
Not Provided

This study is an observational trial which will measure the efficacy of onabotulinumtoxinA in treating Cervical Dystonia.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients with Cervical Dystonia whom are being treated with onabotulinumtoxinA

Cervical Dystonia
Other: No Intervention
No intervention was administered as part of the study.
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.
Intervention: Other: No Intervention
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1046
August 2013
August 2013   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00836017
MedAff BTX-0718
No
Allergan
Allergan
Not Provided
Study Director: Medical Director Allergan
Allergan
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP