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A Safety and Efficacy Study of BOTOX® in Korean Adults With Chronic Migraine

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.
ClinicalTrials.gov Identifier: NCT02147561
Recruitment Status : Completed
First Posted : May 26, 2014
Results First Posted : May 27, 2016
Last Update Posted : May 27, 2016
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Migraine Disorders
Intervention Biological: botulinum toxin Type A
Enrollment 280
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Botulinum Toxin Type A
Hide Arm/Group Description Botulinum toxin Type A injected across specific head and neck muscles on Day 0.
Period Title: Overall Study
Started 280
Completed 276
Not Completed 4
Reason Not Completed
Lost to Follow-up             3
Subjects who didn’t receive BOTOX             1
Arm/Group Title Botulinum Toxin Type A
Hide Arm/Group Description Botulinum toxin Type A injected across specific head and neck muscles on Day 0.
Overall Number of Baseline Participants 279
Hide Baseline Analysis Population Description
The Safety Population included patients enrolled in the study who received study drug. The Safety Population was used to assess the baseline characteristics.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 279 participants
49.81  (14.56)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 279 participants
Female
229
  82.1%
Male
50
  17.9%
1.Primary Outcome
Title Percentage of Patients With Adverse Events
Hide Description An Adverse Event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug.
Time Frame 28 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: patients enrolled in the study who received study drug
Arm/Group Title Botulinum Toxin Type A
Hide Arm/Group Description:
Botulinum toxin Type A injected across specific head and neck muscles on Day 0.
Overall Number of Participants Analyzed 279
Measure Type: Number
Unit of Measure: Percentage of Patients
24.37
2.Secondary Outcome
Title Change From Baseline in Headache Impact Test-6 (HIT-6) Total Score
Hide Description The HIT-6 is a 6 question 5-point scale used to measure the impact of headaches on daily life. The total score ranged from 36 (no impact) to 78 (worst impact). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening.
Time Frame Baseline, Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Population: patients enrolled in the study, who received study drug, and who had an efficacy assessment
Arm/Group Title Botulinum Toxin Type A
Hide Arm/Group Description:
Botulinum toxin Type A injected across specific head and neck muscles on Day 0.
Overall Number of Participants Analyzed 276
Mean (Standard Deviation)
Unit of Measure: Scores on a Scale
Baseline 67.54  (5.83)
Change from Baseline at Day 28 -7.32  (7.98)
3.Secondary Outcome
Title Physician Global Assessment of Outcome on a 3-Point Scale
Hide Description Physicians evaluated patient migraines as improved, no change, or worse compared to baseline.
Time Frame Baseline, Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Population: patients enrolled in the study, who received study drug, and who had an efficacy assessment
Arm/Group Title Botulinum Toxin Type A
Hide Arm/Group Description:
Botulinum toxin Type A injected across specific head and neck muscles on Day 0.
Overall Number of Participants Analyzed 276
Measure Type: Number
Unit of Measure: Patients
Improved 200
No Change 72
Worse 4
Time Frame [Not Specified]
Adverse Event Reporting Description The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs). The Safety Population included patients enrolled in the study who received study drug.
 
Arm/Group Title Botulinum Toxin Type A
Hide Arm/Group Description Botulinum toxin Type A injected across specific head and neck muscles on Day 0.
All-Cause Mortality
Botulinum Toxin Type A
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Botulinum Toxin Type A
Affected / at Risk (%)
Total   4/279 (1.43%) 
Gastrointestinal disorders   
Diarrhoea * 1  1/279 (0.36%) 
General disorders   
Fever * 1  1/279 (0.36%) 
Infections and infestations   
Common Cold * 1  1/279 (0.36%) 
Nervous system disorders   
Migraine * 1  1/279 (0.36%) 
Respiratory, thoracic and mediastinal disorders   
Haemoptysis * 1  1/279 (0.36%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, WHO-ART 092
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Botulinum Toxin Type A
Affected / at Risk (%)
Total   38/279 (13.62%) 
Musculoskeletal and connective tissue disorders   
Muscle Weakness * 1  24/279 (8.60%) 
Nervous system disorders   
Ptosis * 1  14/279 (5.02%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, WHO-ART 092
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: Therapeutic Area Head,
Organization: Allergan, Inc
Phone: 714-246-4500
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT02147561     History of Changes
Other Study ID Numbers: 191622-148
First Submitted: May 22, 2014
First Posted: May 26, 2014
Results First Submitted: March 9, 2016
Results First Posted: May 27, 2016
Last Update Posted: May 27, 2016