Trial Outcomes & Findings for BOTOX® Prophylaxis in Patients With Chronic Migraine (NCT NCT01432379)
NCT ID: NCT01432379
Last Updated: 2019-01-08
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
1168 participants
Primary outcome timeframe
64 weeks
Results posted on
2019-01-08
Participant Flow
Participant milestones
| Measure |
Botulinum Toxin Type A
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 Study
STARTED
|
1168
|
|
Overall Study
COMPLETED
|
783
|
|
Overall Study
NOT COMPLETED
|
385
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
BOTOX® Prophylaxis in Patients With Chronic Migraine
Baseline characteristics by cohort
| Measure |
Botulinum Toxin Type A
n=1160 Participants
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.
|
|---|---|
|
Age, Continuous
|
46.6 Years
STANDARD_DEVIATION 11.75 • n=5 Participants
|
|
Sex: Female, Male
Female
|
977 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
183 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 64 weeksPopulation: Treated Population: all patients who received at least 1 dose of botulinum toxin Type A
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.
Outcome measures
| Measure |
Botulinum Toxin Type A
n=1160 Participants
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.
|
|---|---|
|
Incidence Rate of Dysphagia
|
0.4 events per 1,000 person-months
Interval 0.1 to 0.9
|
SECONDARY outcome
Timeframe: 64 weeksPopulation: Treated Population: all patients who received at least 1 dose of botulinum toxin Type A
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.
Outcome measures
| Measure |
Botulinum Toxin Type A
n=1160 Participants
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.
|
|---|---|
|
Incidence Rate of Intractable Migraine
|
1.6 events per 1,000 person-months
Interval 0.9 to 2.4
|
Adverse Events
Botulinum Toxin Type A
Serious events: 61 serious events
Other events: 106 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Botulinum Toxin Type A
n=1160 participants at risk
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.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.09%
1/1160
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.
|
|
Cardiac disorders
Angina pectoris
|
0.09%
1/1160
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.
|
|
Cardiac disorders
Myocardial infarction
|
0.09%
1/1160
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.
|
|
Cardiac disorders
Pericarditis
|
0.09%
1/1160
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.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.09%
1/1160
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.
|
|
Eye disorders
Retinal detachment
|
0.09%
1/1160
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.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.17%
2/1160
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.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.09%
1/1160
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.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.09%
1/1160
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.
|
|
Gastrointestinal disorders
Incarcerated umbilical hernia
|
0.09%
1/1160
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.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.09%
1/1160
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.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.09%
1/1160
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.
|
|
General disorders
Device malfunction
|
0.09%
1/1160
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.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.09%
1/1160
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.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.09%
1/1160
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.
|
|
Infections and infestations
Chronic sinusitis
|
0.09%
1/1160
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.
|
|
Infections and infestations
Gastroenteritis viral
|
0.09%
1/1160
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.
|
|
Infections and infestations
Herpes zoster
|
0.09%
1/1160
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.
|
|
Infections and infestations
Meningitis
|
0.09%
1/1160
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.
|
|
Infections and infestations
Pneumonia
|
0.09%
1/1160
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.
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.09%
1/1160
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.
|
|
Infections and infestations
Urinary tract infection
|
0.09%
1/1160
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.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.09%
1/1160
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.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.09%
1/1160
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.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.09%
1/1160
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.
|
|
Injury, poisoning and procedural complications
Post lumbar puncture syndrome
|
0.09%
1/1160
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.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.09%
1/1160
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.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.09%
1/1160
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.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.09%
1/1160
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.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.09%
1/1160
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.09%
1/1160
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal carcinoma
|
0.09%
1/1160
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leiomyoma
|
0.09%
1/1160
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.09%
1/1160
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.09%
1/1160
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.09%
1/1160
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lymph nodes
|
0.09%
1/1160
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.
|
|
Nervous system disorders
Migraine
|
0.95%
11/1160
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.
|
|
Nervous system disorders
Headache
|
0.26%
3/1160
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.
|
|
Nervous system disorders
Intracranial pressure increased
|
0.17%
2/1160
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.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.09%
1/1160
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.
|
|
Nervous system disorders
Hemiplegic migraine
|
0.09%
1/1160
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.
|
|
Nervous system disorders
Migraine with aura
|
0.09%
1/1160
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.
|
|
Nervous system disorders
Monoparesis
|
0.09%
1/1160
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.
|
|
Nervous system disorders
VIIth nerve paralysis
|
0.09%
1/1160
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.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion
|
0.09%
1/1160
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.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.09%
1/1160
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.
|
|
Psychiatric disorders
Depression
|
0.26%
3/1160
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.
|
|
Psychiatric disorders
Bipolar disorder
|
0.09%
1/1160
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.
|
|
Psychiatric disorders
Post-traumatic stress disorder
|
0.09%
1/1160
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.
|
|
Psychiatric disorders
Suicide attempt
|
0.09%
1/1160
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.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.09%
1/1160
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.
|
|
Renal and urinary disorders
Urge incontinence
|
0.09%
1/1160
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.
|
|
Reproductive system and breast disorders
Breast haematoma
|
0.09%
1/1160
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.
|
|
Reproductive system and breast disorders
Breast mass
|
0.09%
1/1160
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.
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.09%
1/1160
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.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.09%
1/1160
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.
|
Other adverse events
| Measure |
Botulinum Toxin Type A
n=1160 participants at risk
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.
|
|---|---|
|
Nervous system disorders
Migraine
|
9.1%
106/1160
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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER