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Trial record 24 of 51 for:    Benign Essential Blepharospasm

A Retrospective Chart Review of BOTOX® and Xeomin® for the Treatment of Cervical Dystonia and Blepharospasm

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ClinicalTrials.gov Identifier: NCT01814774
Recruitment Status : Completed
First Posted : March 20, 2013
Results First Posted : July 3, 2014
Last Update Posted : July 3, 2014
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Retrospective
Conditions: Cervical Dystonia
Blepharospasm
Intervention: Other: No Intervention

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
All Participants Retrospective chart review of doses of BOTOX® (onabotulinumtoxinA) and Xeomin® (incobotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.

Participant Flow:   Overall Study
    All Participants
STARTED   48 
COMPLETED   48 
NOT COMPLETED   0 



  Baseline Characteristics

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.
No text entered.

Reporting Groups
  Description
All Participants Retrospective chart review of doses of BOTOX® (onabotulinumtoxinA) and Xeomin® (incobotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.

Baseline Measures
   All Participants 
Overall Participants Analyzed 
[Units: Participants]
 48 
Age 
[Units: Years]
Mean (Standard Deviation)
 64.1  (12.37) 
Gender 
[Units: Participants]
 
Female   35 
Male   13 


  Outcome Measures

1.  Primary:   Dose of Botulinum Toxin Used to Treat Cervical Dystonia   [ Time Frame: 2 Years ]

2.  Primary:   Dose of Botulinum Toxin Used to Treat Blepharospasm   [ Time Frame: 2 Years ]

3.  Secondary:   Number of Participants With Adverse Events   [ Time Frame: 2 Years ]

4.  Secondary:   Botulinum Toxin Inter-injection Interval   [ Time Frame: 2 Years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

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



Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01814774     History of Changes
Other Study ID Numbers: TRU2011
First Submitted: March 18, 2013
First Posted: March 20, 2013
Results First Submitted: June 4, 2014
Results First Posted: July 3, 2014
Last Update Posted: July 3, 2014