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CD-PROBE: Cervical Dystonia Patient Registry for the Observation of Botulinum Toxin Type A Efficacy

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT00836017
First received: February 2, 2009
Last updated: October 4, 2012
Last verified: October 2012
History of Changes

February 2, 2009
October 4, 2012
January 2009
May 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00836017 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
CD-PROBE: Cervical Dystonia Patient Registry for the Observation of Botulinum Toxin Type A Efficacy
Not Provided

This study is an observational trial which will measure the efficacy of botulinum toxin type A 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 botulinum toxin type A
Cervical Dystonia
Biological: Botulinum toxin type A
Treatment not directed by protocol. Directed by treated physician.
Other Name: BOTOX®
Patients receiving botulinum toxin type A
Patients receiving botulinum toxin type A. Treatment not directed by protocol. Directed by treated physician.
Intervention: Biological: Botulinum toxin type A
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1046
May 2013
May 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
October 2012

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