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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
Enrollment 48
Recruitment Details  
Pre-assignment Details  
Arm/Group Title All Participants
Hide Arm/Group Description Retrospective chart review of doses of BOTOX® (onabotulinumtoxinA) and Xeomin® (incobotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.
Period Title: Overall Study
Started 48
Completed 48
Not Completed 0
Arm/Group Title All Participants
Hide Arm/Group Description Retrospective chart review of doses of BOTOX® (onabotulinumtoxinA) and Xeomin® (incobotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.
Overall Number of Baseline Participants 48
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 48 participants
64.1  (12.37)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants
Female
35
  72.9%
Male
13
  27.1%
1.Primary Outcome
Title Dose of Botulinum Toxin Used to Treat Cervical Dystonia
Hide Description The average dose of botulinum toxin received per patient per year was calculated.
Time Frame 2 Years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants diagnosed with Cervical Dystonia who received onabotulinumtoxinA for 2 years and incobotulinumtoxinA for 2 years.
Arm/Group Title BOTOX® Xeomin®
Hide Arm/Group Description:
Retrospective chart review of doses of BOTOX® (onabotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.
Retrospective chart review of doses of Xeomin® (incobotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.
Overall Number of Participants Analyzed 25 25
Mean (95% Confidence Interval)
Unit of Measure: units per patient per year
444.70
(347.16 to 542.24)
536.30
(409.64 to 662.96)
2.Primary Outcome
Title Dose of Botulinum Toxin Used to Treat Blepharospasm
Hide Description The average dose of botulinum toxin received per patient per year was calculated.
Time Frame 2 Years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants diagnosed with Blepharospasm who received onabotulinumtoxinA for 2 years and incobotulinumtoxinA for 2 years.
Arm/Group Title BOTOX® Xeomin®
Hide Arm/Group Description:
Retrospective chart review of doses of BOTOX® (onabotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.
Retrospective chart review of doses of Xeomin® (incobotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.
Overall Number of Participants Analyzed 14 14
Mean (95% Confidence Interval)
Unit of Measure: units per patient per year
50.40
(21.21 to 79.59)
64.01
(33.32 to 94.70)
3.Secondary Outcome
Title Number of Participants With Adverse Events
Hide Description An Adverse Event was any unfavorable and unintended sign, symptom, or disease documented in the medical chart that occurred after treatment with botulinum toxin, or pre-existing conditions that worsened during the retrospective period.
Time Frame 2 Years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least one dose of botulinum toxin.
Arm/Group Title BOTOX® Xeomin®
Hide Arm/Group Description:
Retrospective chart review of doses of BOTOX® (onabotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.
Retrospective chart review of doses of Xeomin® (incobotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.
Overall Number of Participants Analyzed 48 48
Measure Type: Number
Unit of Measure: participants
12 10
4.Secondary Outcome
Title Botulinum Toxin Inter-injection Interval
Hide Description Injection-interval was the time in weeks between injections of botulinum toxin.
Time Frame 2 Years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who received onabotulinumtoxinA for 2 years and incobotulinumtoxinA for 2 years.
Arm/Group Title BOTOX® Xeomin®
Hide Arm/Group Description:
Retrospective chart review of doses of BOTOX® (onabotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.
Retrospective chart review of doses of Xeomin® (incobotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.
Overall Number of Participants Analyzed 39 39
Mean (Standard Deviation)
Unit of Measure: weeks
15.83  (4.02) 14.39  (3.38)
Time Frame 2 Years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title BOTOX® Xeomin®
Hide Arm/Group Description Retrospective chart review of doses of BOTOX® (onabotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered. Retrospective chart review of doses of Xeomin® (incobotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.
All-Cause Mortality
BOTOX® Xeomin®
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
BOTOX® Xeomin®
Affected / at Risk (%) Affected / at Risk (%)
Total   0/48 (0.00%)   0/48 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
BOTOX® Xeomin®
Affected / at Risk (%) Affected / at Risk (%)
Total   7/48 (14.58%)   4/48 (8.33%) 
Eye disorders     
Ptosis *  3/48 (6.25%)  3/48 (6.25%) 
Gastrointestinal disorders     
Dysphagia *  4/48 (8.33%)  1/48 (2.08%) 
*
Indicates events were collected by non-systematic assessment
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.
A 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 90 days from the time submitted to the sponsor for review. 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
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