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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
Results First Received: June 19, 2014  
Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Condition: Cervical Dystonia
Intervention: Other: No Intervention

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    BOTOX®  
STARTED     1046  
COMPLETED     502  
NOT COMPLETED     544  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Baseline measures were based on all enrolled participants who received treatment.

Reporting Groups
  Description
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.

Baseline Measures
    BOTOX®  
Number of Participants  
[units: participants]
  1041  
Age  
[units: Years]
Mean ± Standard Deviation
  58.0  ± 14.7  
Gender  
[units: Participants]
 
Female     774  
Male     267  



  Outcome Measures
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1.  Primary:   Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score   [ Time Frame: 4-6 weeks after treatment 3 (Up to 104.3 weeks) ]

2.  Secondary:   Percentage of Participants With Cervical Dystonia (CD) Severity Mild   [ Time Frame: Baseline, 4-6 weeks after treatment 3 (Up to 104.3 weeks) ]

3.  Secondary:   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) ]

4.  Secondary:   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) ]

5.  Secondary:   Pain Numeric Rating Scale Score   [ Time Frame: Baseline, 4-6 weeks after treatment 3 (Up to 104.3 weeks) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Vice President Medical Affairs,
Organization: Allergan, Inc
phone: 714-246-4500
e-mail: clinicaltrials@allergan.com


No publications provided by Allergan

Publications automatically indexed to this study:

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00836017     History of Changes
Other Study ID Numbers: MedAff BTX-0718
Study First Received: February 2, 2009
Results First Received: June 19, 2014
Last Updated: June 19, 2014
Health Authority: United States: Institutional Review Board