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BOTOX® Prophylaxis in Patients With Chronic Migraine

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ClinicalTrials.gov Identifier: NCT01432379
Recruitment Status : Completed
First Posted : September 13, 2011
Results First Posted : December 12, 2016
Last Update Posted : January 8, 2019
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Migraine Disorders
Intervention Biological: botulinum toxin Type A
Enrollment 1168
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Botulinum Toxin Type A
Hide Arm/Group Description 155-195 U of botulinum toxin Type A administered intramuscularly in the face, head, and neck areas as directed by physician (approximately every 12 weeks) for 1 year.
Period Title: Overall Study
Started 1168
Completed 783
Not Completed 385
Arm/Group Title Botulinum Toxin Type A
Hide Arm/Group Description 155-195 U of botulinum toxin Type A administered intramuscularly in the face, head, and neck areas as directed by physician (approximately every 12 weeks) for 1 year.
Overall Number of Baseline Participants 1160
Hide Baseline Analysis Population Description
The Treated Population includes all patients who received at least 1 dose of botulinum toxin Type A and is used for baseline characteristics.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1160 participants
46.6  (11.75)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1160 participants
Female
977
  84.2%
Male
183
  15.8%
1.Primary Outcome
Title Incidence Rate of Dysphagia
Hide Description Incidence rates are reported for subjects with events per 1,000 person-months and are based on the first reported occurrence of dysphagia from study enrollment up to 64 weeks. Dysphagia is difficulty or discomfort swallowing.
Time Frame 64 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Treated Population: all patients who received at least 1 dose of botulinum toxin Type A
Arm/Group Title Botulinum Toxin Type A
Hide Arm/Group Description:
155-195 U of botulinum toxin Type A administered intramuscularly in the face, head, and neck areas as directed by physician (approximately every 12 weeks) for 1 year.
Overall Number of Participants Analyzed 1160
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: events per 1,000 person-months
0.4
(0.1 to 0.9)
2.Secondary Outcome
Title Incidence Rate of Intractable Migraine
Hide Description Incidence rates are reported for subjects with events per 1,000 person-months and are based on the first reported occurrence of intractable migraine from study enrollment up to 64 weeks. Intractable migraine is a migraine that does not seem to go away.
Time Frame 64 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Treated Population: all patients who received at least 1 dose of botulinum toxin Type A
Arm/Group Title Botulinum Toxin Type A
Hide Arm/Group Description:
155-195 U of botulinum toxin Type A administered intramuscularly in the face, head, and neck areas as directed by physician (approximately every 12 weeks) for 1 year.
Overall Number of Participants Analyzed 1160
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: events per 1,000 person-months
1.6
(0.9 to 2.4)
Time Frame [Not Specified]
Adverse Event Reporting Description The Treated Population includes all patients who received at least 1 dose of botulinum toxin Type A and is used to assess adverse events and serious adverse events.
 
Arm/Group Title Botulinum Toxin Type A
Hide Arm/Group Description 155-195 U of botulinum toxin Type A administered intramuscularly in the face, head, and neck areas as directed by physician (approximately every 12 weeks) for 1 year.
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   61/1160 (5.26%) 
Blood and lymphatic system disorders   
Anaemia  1  1/1160 (0.09%) 
Cardiac disorders   
Angina pectoris  1  1/1160 (0.09%) 
Myocardial infarction  1  1/1160 (0.09%) 
Pericarditis  1  1/1160 (0.09%) 
Ear and labyrinth disorders   
Vertigo positional * 1  1/1160 (0.09%) 
Eye disorders   
Retinal detachment  1  1/1160 (0.09%) 
Gastrointestinal disorders   
Abdominal pain upper * 1  2/1160 (0.17%) 
Gastric ulcer  1  1/1160 (0.09%) 
Gastrointestinal pain * 1  1/1160 (0.09%) 
Incarcerated umbilical hernia  1  1/1160 (0.09%) 
Inguinal hernia  1  1/1160 (0.09%) 
Intestinal obstruction  1  1/1160 (0.09%) 
General disorders   
Device malfunction  1  1/1160 (0.09%) 
Hepatobiliary disorders   
Cholecystitis  1  1/1160 (0.09%) 
Cholecystitis chronic  1  1/1160 (0.09%) 
Infections and infestations   
Chronic sinusitis  1  1/1160 (0.09%) 
Gastroenteritis viral * 1  1/1160 (0.09%) 
Herpes zoster * 1  1/1160 (0.09%) 
Meningitis  1  1/1160 (0.09%) 
Pneumonia  1  1/1160 (0.09%) 
Pneumonia pneumococcal  1  1/1160 (0.09%) 
Urinary tract infection  1  1/1160 (0.09%) 
Injury, poisoning and procedural complications   
Craniocerebral injury  1  1/1160 (0.09%) 
Femoral neck fracture  1  1/1160 (0.09%) 
Hip fracture  1  1/1160 (0.09%) 
Post lumbar puncture syndrome  1  1/1160 (0.09%) 
Radius fracture  1  1/1160 (0.09%) 
Musculoskeletal and connective tissue disorders   
Intervertebral disc protrusion  1  1/1160 (0.09%) 
Musculoskeletal chest pain * 1  1/1160 (0.09%) 
Rotator cuff syndrome  1  1/1160 (0.09%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Breast cancer  1  1/1160 (0.09%) 
Gastrointestinal carcinoma  1  1/1160 (0.09%) 
Leiomyoma  1  1/1160 (0.09%) 
Lipoma  1  1/1160 (0.09%) 
Lung neoplasm malignant  1  1/1160 (0.09%) 
Metastases to central nervous system  1  1/1160 (0.09%) 
Metastases to lymph nodes  1  1/1160 (0.09%) 
Nervous system disorders   
Migraine * 1  11/1160 (0.95%) 
Headache * 1  3/1160 (0.26%) 
Intracranial pressure increased  1  2/1160 (0.17%) 
Cerebrovascular accident  1  1/1160 (0.09%) 
Hemiplegic migraine * 1  1/1160 (0.09%) 
Migraine with aura * 1  1/1160 (0.09%) 
Monoparesis * 1  1/1160 (0.09%) 
VIIth nerve paralysis  1  1/1160 (0.09%) 
Pregnancy, puerperium and perinatal conditions   
Abortion  1  1/1160 (0.09%) 
Abortion spontaneous  1  1/1160 (0.09%) 
Psychiatric disorders   
Depression  1  3/1160 (0.26%) 
Bipolar disorder  1  1/1160 (0.09%) 
Post-traumatic stress disorder  1  1/1160 (0.09%) 
Suicide attempt * 1  1/1160 (0.09%) 
Renal and urinary disorders   
Nephrolithiasis  1  1/1160 (0.09%) 
Urge incontinence * 1  1/1160 (0.09%) 
Reproductive system and breast disorders   
Breast haematoma * 1  1/1160 (0.09%) 
Breast mass  1  1/1160 (0.09%) 
Cervical dysplasia  1  1/1160 (0.09%) 
Respiratory, thoracic and mediastinal disorders   
Pulmonary embolism  1  1/1160 (0.09%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA version 13.1
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   106/1160 (9.14%) 
Nervous system disorders   
Migraine * 1  106/1160 (9.14%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA version 13.1
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 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: NCT01432379     History of Changes
Other Study ID Numbers: 191622-110
First Submitted: September 9, 2011
First Posted: September 13, 2011
Results First Submitted: July 26, 2016
Results First Posted: December 12, 2016
Last Update Posted: January 8, 2019