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A Long-term Efficacy, Safety, and Tolerability Study of BOTOX® in Patients With Chronic Migraine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01516892
First received: January 20, 2012
Last updated: November 9, 2016
Last verified: November 2016
Results First Received: November 9, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Migraine Disorders
Intervention: Biological: onabotulinumtoxinA

  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® Participants received 155 U of onabotulinumtoxinA (BOTOX®) approximately every 12 weeks for 108 weeks. OnabotulinumtoxinA was administered as 31 intramuscular injections in 7 head/neck muscle areas.

Participant Flow:   Overall Study
    BOTOX®
STARTED   716 
COMPLETED   373 
NOT COMPLETED   343 
Adverse Event                25 
Lack of Efficacy                35 
Pregnancy                5 
Lost to Follow-up                82 
Subject Withdrew Consent                92 
Protocol Violation                60 
Other Miscellaneous Reasons                43 
Missing                1 



  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.
All enrolled participants.

Reporting Groups
  Description
BOTOX® Participants received 155 U of onabotulinumtoxinA (BOTOX®) approximately every 12 weeks for 108 weeks. OnabotulinumtoxinA was administered as 31 intramuscular injections in 7 head/neck muscle areas.

Baseline Measures
   BOTOX® 
Overall Participants Analyzed 
[Units: Participants]
 716 
Age, Customized 
[Units: Participants]
 
< 40 years   270 
≥ 40 years   446 
Gender 
[Units: Participants]
Count of Participants
 
Female      607  84.8% 
Male      109  15.2% 


  Outcome Measures
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1.  Primary:   Change From Baseline in the Frequency of Headache Days   [ Time Frame: Baseline, Week 108 ]

2.  Secondary:   Change From Baseline in the Frequency of Headache Days   [ Time Frame: Baseline, Week 60 ]

3.  Secondary:   Change From Baseline in Headache Impact Test Questionnaire (HIT-6) Total Score   [ Time Frame: Baseline, Week 60, Week 108 ]


  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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01516892     History of Changes
Other Study ID Numbers: GMA-BTX-CM-10-001
The COMPEL Study ( Other Identifier: Allergan, Inc )
Study First Received: January 20, 2012
Results First Received: November 9, 2016
Last Updated: November 9, 2016