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

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ClinicalTrials.gov Identifier: NCT01516892
Recruitment Status : Completed
First Posted : January 25, 2012
Results First Posted : January 6, 2017
Last Update Posted : January 6, 2017
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: onabotulinumtoxinA
Enrollment 716

Recruitment Details  
Pre-assignment Details  
Arm/Group Title BOTOX®
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 716
Completed 373
Not Completed 343
Reason Not Completed
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
Arm/Group Title BOTOX®
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 716
Hide Baseline Analysis Population Description
All enrolled participants.
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 716 participants
< 40 years 270
≥ 40 years 446
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 716 participants
Female
607
  84.8%
Male
109
  15.2%
1.Primary Outcome
Title Change From Baseline in the Frequency of Headache Days
Time Frame Baseline, Week 108
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis Population included all enrolled participants who had at least one efficacy assessment at baseline or a post-baseline visit.
Arm/Group Title BOTOX®
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 715
Mean (Standard Deviation)
Unit of Measure: headache days
Baseline 22.0  (4.82)
Change from Baseline at Week 108 -10.7  (6.44)
2.Secondary Outcome
Title Change From Baseline in the Frequency of Headache Days
Time Frame Baseline, Week 60
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis Population included all enrolled participants who had at least one efficacy assessment at baseline or a post-baseline visit.
Arm/Group Title BOTOX®
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 715
Mean (Standard Deviation)
Unit of Measure: headache days
Baseline 22.0  (4.82)
Change from Baseline at Week 60 -9.2  (6.22)
3.Secondary Outcome
Title Change From Baseline in Headache Impact Test Questionnaire (HIT-6) Total Score
Hide Description The HIT-6 measures the impact of headache and treatment on the participant’s functional health and well-being in 6 domains: pain; role functioning (ability to carry out usual activities); social functioning; energy or fatigue; cognition; and emotional distress assessed over the prior 4-week period. The total possible score ranges from 36 (no impact) to 78 (worst impact). A negative change from Baseline indicates an improvement, and a positive change from Baseline indicates a worsening.
Time Frame Baseline, Week 60, Week 108
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants from the Analysis Population, all enrolled participants who had at least one efficacy assessment at baseline or a post-baseline visit, with data available for analysis.
Arm/Group Title BOTOX®
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 713
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 64.7  (4.82)
Change from Baseline at Week 60 -6.8  (6.55)
Change from Baseline at Week 108 -7.1  (7.24)
Time Frame 108 Weeks
Adverse Event Reporting Description Safety population included all participants who received at least one BOTOX® treatment injection.
 
Arm/Group Title BOTOX®
Hide Arm/Group Description 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.
All-Cause Mortality
BOTOX®
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
BOTOX®
Affected / at Risk (%)
Total   75/716 (10.47%) 
Cardiac disorders   
Aortic valve incompetence  1  1/716 (0.14%) 
Atrial fibrillation  1  1/716 (0.14%) 
Cardiac failure congestive  1  1/716 (0.14%) 
Congestive cardiomyopathy  1  1/716 (0.14%) 
Myocardial infarction  1  1/716 (0.14%) 
Endocrine disorders   
Cushing’s syndrome  1  1/716 (0.14%) 
Eye disorders   
Cataract subcapsular  1  1/716 (0.14%) 
Gastrointestinal disorders   
Colitis ischaemic  1  1/716 (0.14%) 
Colonic polyp  1  1/716 (0.14%) 
Constipation * 1  1/716 (0.14%) 
Gastritis  1  1/716 (0.14%) 
Hiatus hernia  1  1/716 (0.14%) 
Intestinal obstruction  1  1/716 (0.14%) 
Pancreatitis  1  1/716 (0.14%) 
General disorders   
Chest discomfort * 1  1/716 (0.14%) 
Device intolerance * 1  1/716 (0.14%) 
Fatigue * 1  1/716 (0.14%) 
Non-cardiac chest pain * 1  3/716 (0.42%) 
Pyrexia  1  1/716 (0.14%) 
Immune system disorders   
Anaphylactic reaction * 1  1/716 (0.14%) 
Infections and infestations   
Appendicitis  1  1/716 (0.14%) 
Bronchitis  1  1/716 (0.14%) 
Gastrointestinal infection  1  1/716 (0.14%) 
Influenza  1  1/716 (0.14%) 
Meningitis viral  1  1/716 (0.14%) 
Pneumonia  1  1/716 (0.14%) 
Pyelonephritis acute  1  1/716 (0.14%) 
Sinusitis  1  1/716 (0.14%) 
Injury, poisoning and procedural complications   
Alcohol poisoning  1  1/716 (0.14%) 
Contusion * 1  1/716 (0.14%) 
Fall * 1  1/716 (0.14%) 
Fibula fracture  1  1/716 (0.14%) 
Head injury  1  1/716 (0.14%) 
Ligament injury  1  1/716 (0.14%) 
Meniscus lesion  1  1/716 (0.14%) 
Procedural pain * 1  2/716 (0.28%) 
Rib fracture  1  1/716 (0.14%) 
Tibia fracture  1  1/716 (0.14%) 
Investigations   
Electrocardiogram abnormal  1  1/716 (0.14%) 
Metabolism and nutrition disorders   
Diabetes mellitus  1  1/716 (0.14%) 
Diabetic ketoacidosis  1  1/716 (0.14%) 
Hypocalcaemia  1  1/716 (0.14%) 
Hypoglycaemia  1  1/716 (0.14%) 
Obesity  1  1/716 (0.14%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  1/716 (0.14%) 
Groin pain * 1  1/716 (0.14%) 
Intervertebral disc protrusion  1  2/716 (0.28%) 
Periarthritis  1  1/716 (0.14%) 
Rotator cuff syndrome  1  2/716 (0.28%) 
Synovial cyst  1  1/716 (0.14%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Angiomyolipoma  1  1/716 (0.14%) 
Basal cell carcinoma  1  1/716 (0.14%) 
Breast cancer  1  1/716 (0.14%) 
Extranodal marginal zone B-cell lymphoma (MALT type)  1  1/716 (0.14%) 
Lung neoplasm malignant  1  1/716 (0.14%) 
Malignant melanoma  1  3/716 (0.42%) 
Mantle cell lymphoma  1  1/716 (0.14%) 
Nervous system disorders   
Convulsion  1  1/716 (0.14%) 
Diabetic hyperosmolar coma  1  1/716 (0.14%) 
Dizziness * 1  2/716 (0.28%) 
Headache * 1  3/716 (0.42%) 
Hypoaesthesia  1  1/716 (0.14%) 
Intracranial hypotension  1  1/716 (0.14%) 
Loss of consciousness * 1  1/716 (0.14%) 
Migraine * 1  6/716 (0.84%) 
Paraesthesia * 1  1/716 (0.14%) 
Presyncope * 1  1/716 (0.14%) 
Syncope * 1  1/716 (0.14%) 
Tension headache * 1  1/716 (0.14%) 
Transient ischaemic attack  1  1/716 (0.14%) 
Psychiatric disorders   
Bipolar disorder  1  1/716 (0.14%) 
Depression  1  1/716 (0.14%) 
Major depression  1  1/716 (0.14%) 
Panic attack  1  2/716 (0.28%) 
Suicidal ideation  1  5/716 (0.70%) 
Renal and urinary disorders   
Calculus ureteric  1  1/716 (0.14%) 
Nephrolithiasis  1  1/716 (0.14%) 
Reproductive system and breast disorders   
Dysfunctional uterine bleeding  1  1/716 (0.14%) 
Ovarian cyst  1  1/716 (0.14%) 
Respiratory, thoracic and mediastinal disorders   
Sleep apnoea syndrome  1  1/716 (0.14%) 
Skin and subcutaneous tissue disorders   
Rash generalised * 1  1/716 (0.14%) 
Surgical and medical procedures   
Cholecystectomy  1  1/716 (0.14%) 
Hysterectomy  1  1/716 (0.14%) 
Vascular disorders   
Thrombosis  1  1/716 (0.14%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 15.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
BOTOX®
Affected / at Risk (%)
Total   75 
Infections and infestations   
Sinusitis  1  37/716 (5.17%) 
Musculoskeletal and connective tissue disorders   
Neck pain * 1  38/716 (5.31%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 15.1
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 results publication or presentations be submitted for sponsor review no less than 90 days in advance, during which the sponsor can embargo such communications prior to public release. The embargo may be extended for up to 90 days for the sponsor to preserve its proprietary rights. PI will not publish study results prior to release of a multicenter manuscript including data from all study centers. The sponsor cannot require changes to the communication.
Results Point of Contact
Name/Title: Vice President Medical Affairs,
Organization: Allergan, Inc
Phone: 714-246-4500
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 )
First Submitted: January 20, 2012
First Posted: January 25, 2012
Results First Submitted: November 9, 2016
Results First Posted: January 6, 2017
Last Update Posted: January 6, 2017