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MDs on Botox Utility (MOBILITY)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00535938
First Posted: September 27, 2007
Last Update Posted: September 10, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Allergan
Results First Submitted: September 4, 2014  
Study Type: Observational
Study Design: Time Perspective: Prospective
Conditions: Blepharospasm
Torticollis
Strabismus
Muscle Spasticity
Intervention: Other: botulinum toxin type A

  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
Naïve to Botox® Treatment Initiating treatment with BOTOX® upon entry to the project.
Non-naïve to Botox® Treatment Receiving ongoing treatment with BOTOX® upon entry to the project.

Participant Flow:   Overall Study
    Naïve to Botox® Treatment   Non-naïve to Botox® Treatment
STARTED   506   866 
COMPLETED   115   404 
NOT COMPLETED   391   462 



  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.
No text entered.

Reporting Groups
  Description
Naïve to Botox® Treatment Initiating treatment with BOTOX® upon entry to the project.
Non-naïve to Botox® Treatment Receiving ongoing treatment with BOTOX® upon entry to the project.
Total Total of all reporting groups

Baseline Measures
   Naïve to Botox® Treatment   Non-naïve to Botox® Treatment   Total 
Overall Participants Analyzed 
[Units: Participants]
 506   866   1372 
Age, Customized 
[Units: Participants]
     
14 to 17 years   22   28   50 
18 to 65 years   374   641   1015 
>65 years   110   197   307 
Gender 
[Units: Participants]
     
Female   304   577   881 
Male   202   289   491 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Cervical Dystonia   [ Time Frame: Baseline, SV1 (up to 505 days) ]

2.  Primary:   Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Blepharospasm   [ Time Frame: Baseline, SV1 (up to 542 days) ]

3.  Primary:   Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Hyperhidrosis   [ Time Frame: Baseline, SV1 (up to 1,273 days) ]

4.  Primary:   Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Cerebral Palsy   [ Time Frame: Baseline, SV1 (up to 925 days) ]

5.  Primary:   Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Adult Focal Spasticity   [ Time Frame: Baseline, SV1 (up to 1,562 days) ]

6.  Primary:   Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Facial Nerve Disorder   [ Time Frame: Baseline, SV1 (up to 765 days) ]

7.  Primary:   Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With "Other" Disorders   [ Time Frame: Baseline, SV1 (up to 568 days) ]

8.  Secondary:   BOTOX® Dose in Patients With Cervical Dystonia   [ Time Frame: Baseline, SV1 (up to 505 days) ]

9.  Secondary:   BOTOX® Dose in Patients With Blepharospasm   [ Time Frame: Baseline, SV1 (up to 542 days) ]

10.  Secondary:   BOTOX® Dose in Patients With Hyperhidrosis   [ Time Frame: Baseline, SV1 (up to 1,273 days) ]

11.  Secondary:   BOTOX® Dose in Patients With Adult Focal Spasticity   [ Time Frame: Baseline, SV1 (up to 1,562 days) ]

12.  Secondary:   BOTOX® Dose in Patients With Cerebral Palsy   [ Time Frame: Baseline, SV1 (up to 925 days) ]

13.  Secondary:   BOTOX® Dose in Patients With Facial Nerve Disorder   [ Time Frame: Baseline, SV1 (up to 765 days) ]

14.  Secondary:   BOTOX® Dose in Patients With "Other" Disorders   [ Time Frame: Baseline, SV1 (up to 568 days) ]

15.  Secondary:   Concurrent Procedure Resource Utilization Patterns   [ Time Frame: Up to 1,785 days ]

16.  Secondary:   Concurrent Surgical Procedure Resource Utilization Patterns   [ Time Frame: Up to 1,785 days ]


  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



Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00535938     History of Changes
Other Study ID Numbers: AGN/MMC B00705
First Submitted: September 25, 2007
First Posted: September 27, 2007
Results First Submitted: September 4, 2014
Results First Posted: September 10, 2014
Last Update Posted: September 10, 2014