Study of BOTOX Injections in Prevention of Migraine in Ad... | NCT05028569 | Trialant
NCT05028569
Sponsor
AbbVie
Status
Terminated
Last Update Posted
Dec 9, 2025Actual
Enrollment
775Actual
Phase
Phase 3
Conditions
Episodic Migraine
Interventions
BOTOX
Placebo
Countries
United States
Canada
Czechia
Germany
Israel
Poland
Spain
Sweden
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT05028569
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
M21-307
Secondary IDs
ID
Type
Description
Link
2021-001979-16
EudraCT Number
Brief Title
Study of BOTOX Injections in Prevention of Migraine in Adult Participants With Episodic Migraine
Official Title
Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study of BOTOX (Botulinum Toxin Type A) for the Prevention of Migraine in Subjects With Episodic Migraine
Acronym
Not provided
Organization
AbbVieINDUSTRY
Status Module
Record Verification Date
Nov 2025
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
The study was terminated early due to lack of efficacy from the primary analysis results.
Expanded Access Info
No
Start Date
Nov 5, 2021Actual
Primary Completion Date
Nov 6, 2024Actual
Completion Date
Nov 6, 2024Actual
First Submitted Date
Aug 25, 2021
First Submission Date that Met QC Criteria
Aug 25, 2021
First Posted Date
Aug 31, 2021Actual
Results Waived
Not provided
Results First Submitted Date
Oct 31, 2025
Results First Submitted that Met QC Criteria
Nov 24, 2025
Results First Posted Date
Dec 9, 2025Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Aug 21, 2025
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Dec 9, 2025Actual
Last Update Submitted Date
Nov 24, 2025
Last Update Posted Date
Dec 9, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
AbbVieINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
No
FDAAA801 Violation
Not provided
Description Module
Brief Summary
Migraine is a neurological disease characterized by moderate or severe headache, associated with nausea, vomiting, and/or sensitivity to light and sound (International Classification of Headache Disorders, 2018). Migraine can be further categorized according to the frequency of attacks as episodic migraine (EM) or chronic migraine (CM). This study will assess the effects of BOTOX in preventing migraine in adult participants with EM.
BOTOX is being developed for the prevention of migraine in adults with episodic migraine (EM). Participants will be enrolled in 3 different treatment groups. There is 1 in 3 chance that participants will be assigned to receive placebo. Approximately 777 adult participants with EM will be enrolled in approximately 125 sites across the world.
Participants will receive intramuscular injections (injected into the muscle) of BOTOX or Placebo on Day 1 and Week 12. Eligible participants will receive BOTOX on Week 24 and Week 36.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Detailed Description
Not provided
Conditions Module
Conditions
Episodic Migraine
Keywords
Migraine
Episodic Migraine
BOTOX
Botulinum Toxin Type A
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
775Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Double-Blind Phase: Placebo
Placebo Comparator
Participants received placebo for BOTOX intramuscular injections in the head/neck muscles on Day 1 and Week 12.
Drug: Placebo
Double-Blind Phase: BOTOX 155 U
Experimental
Participants received intramuscular injections of BOTOX 155 U in the head/neck muscles on Day 1 and Week 12.
Drug: BOTOX
Double-Blind Phase: BOTOX 195 U
Experimental
Participants received intramuscular injections of BOTOX 195 U in the head/neck muscles on Day 1 and Week 12.
Drug: BOTOX
Open-Label Phase: BOTOX 195 U
Experimental
Eligible participants received intramuscular injections of BOTOX 195 U in the head/neck muscles on Weeks 24 and 36.
Drug: BOTOX
Interventions
Name
Type
Description
Arm Group Labels
Other Names
BOTOX
Drug
Intramuscular Injection
Double-Blind Phase: BOTOX 155 U
Double-Blind Phase: BOTOX 195 U
Open-Label Phase: BOTOX 195 U
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Change From Baseline in the Frequency of Monthly Migraine Days Across Months 5 and 6
The frequency of monthly migraine days across Months 5 and 6 is calculated by taking the 2-month average of monthly migraine days over Months 5 and 6. Month 5 and Month 6 are the 28-day daily diary periods ending with Days 56 and Days 84 after the second study treatment intervention day with BOTOX or placebo injections, respectively. Negative changes from Baseline indicate improvement.
Baseline, Months 5-6
Number of Participants With Treatment-Emergent Adverse Events (AEs)
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.
Change From Baseline in the Frequency of Monthly Headache Days Across Months 5 and 6
The frequency of monthly headache days across Months 5 and 6 is calculated by taking the 2-month average of monthly headache days over Months 5 and 6. Month 5 and Month 6 are the 28-day daily diary periods ending with Days 56 and Days 84 after the second study treatment intervention day with BOTOX or placebo injections, respectively. Negative changes from Baseline indicate improvement.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
History of migraine headache disorder meeting International Classification of Headache Disorders (ICHD)-3 diagnostic criteria for migraine with aura or migraine without aura for >= 12 months.
Onset of migraine before 50 years of age.
History of 6 to 14 migraine days/month in each of the 3 months prior to Visit 1.
Six to 14 migraine/probable migraine days during the 4-week screening/baseline phase.
Less than 15 headache days/month in each of the 3 months prior to Visit 1 and during the 4-week screening/baseline phase.
Exclusion Criteria:
Current diagnosis of chronic migraine according to ICHD-3.
History or current diagnosis of migraine with brainstem aura, retinal migraine, complications of migraine, chronic tension-type headache, trigeminal autonomic cephalalgias, hypnic headache, hemicrania continua, or new daily persistent headache.
History of headache attributed to another disorder (e.g., cervical dystonia, craniotomy, head/neck trauma) with exception that medication overuse headache per ICHD-3 criteria is allowed.
History of inadequate response to > 4 prophylactic treatment for migraine, 2 of which have different mechanisms of action.
Female who is pregnant, breastfeeding, or considering becoming pregnant during the study or within 90 days after the last dose of study drug.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
65 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
ABBVIE INC.
AbbVie
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Neurology and Neurodiagnostics of Alabama /ID# 231918
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
Participants were randomized in a 1:1:1 ratio to receive 2 treatment cycles of BOTOX 195 U, BOTOX 155 U, or placebo. BOTOX (155 U or 195 U) or matching placebo was administered by a trained injector at Day 1 and Week 12 of the Double-Blind Phase. Those who continued to the Open-label Phase received BOTOX 195 U at 12-week intervals for up to 2 treatment cycles.
Recruitment Details
This study was conducted at 118 sites in 9 countries and was initiated in November 2021. Adults with episodic migraine (EM) were eligible.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Screening/Baseline Phase
Participants with 6 to 14 migraine days and < 15 headache days per month in each of the 3 months prior to the screening visit (Visit 1) and during the 4-week Screening/Baseline Phase were randomized in this study.
Percentage of Participants With ≥ 50% Reduction From Baseline in the Frequency of Monthly Migraine Days Across Months 5 and 6
The frequency of monthly migraine days across Months 5 and 6 is calculated by taking the 2-month average of monthly migraine days over Months 5 and 6. Month 5 and Month 6 are the 28-day daily diary periods ending with Days 56 and Days 84 after the second study treatment intervention day with BOTOX or placebo injections, respectively. The responder status of 50% reduction from Baseline is defined as a participant with at least a 50% reduction from Baseline in the 2-month average of monthly migraine days over Months 5 and 6.
Baseline, Months 5-6
Change From Baseline in the Frequency of Monthly Acute Headache Medication Days Across Months 5 and 6
Monthly acute headache medication days across Months 5 and 6 is calculated by taking the 2-month average of monthly acute headache medication days over Months 5 and 6. Month 5 and Month 6 are the 28-day daily diary periods ending with Days 56 and Days 84 after the second study treatment intervention day with BOTOX or placebo injections, respectively. Negative changes from Baseline indicate improvement.
Baseline, Months 5-6
Change From Baseline in Migraine-Specific Quality of Life Questionnaire Version 2.1 (MSQ v2.1) Role Function - Restrictive (RFR) Domain Score At Month 6
The MSQ v2.1 is a 14-item questionnaire designed to measure health-related quality of life impairments attributed to migraine over the past 4 weeks. It is divided into 3 domains, and the Role Function Restrictive (RFR) assesses how migraines limit one's daily social and work-related activities using a 6-point scale ranging from "none of the time" to "all of the time". Raw dimension scores are computed as a sum of item responses and rescaled to a 0 to 100 scale, where higher scores indicate better quality of life. Positive changes from Baseline indicate improvement.
Baseline, Month 6
Change From Baseline in the Activity Impairment in Migraine - Diary (AIM-D) Physical Impairment Domain Score Across Months 5 and 6
AIM-D Physical Impairment Domain score is calculated based on the summation of AIM-D items 6-9. Participants answer each question based on the level of difficulty experienced in the 24 hours prior, with "during your headache" indicated for when they reported a headache, using a 6-point rating scale ranging from "not difficult at all" to "extremely difficult". The raw daily score is transformed to a 0-100 scale, and the monthly score is calculated using the average daily scores, where a higher score indicates worse physical impairment. AIM-D Physical Impairment domain score across Months 5 and 6 is calculated by taking the 2-month average of AIM-D Physical Impairment domain scores over Months 5 and 6. Month 5 and Month 6 are the 28-day daily diary periods ending with Days 56 and Days 84 after the second study treatment intervention day with BOTOX or placebo injections, respectively. Negative changes from Baseline indicate improvement.
Baseline, Months 5-6
Change From Baseline in the Total 6-item Headache Impact Test (HIT-6) Score Across Months 5 and 6
The HIT-6 is a 6-item assessment used to measure the impact headaches have on a participant's ability to function on the job, at school, at home and in social situations. It assesses the effect that headaches have on normal daily life and the subject's ability to function. Responses are based on frequency using a 5-point scale ranging from "never" to "always." The HIT-6 total score, which ranges from 36 to 78, is the sum of the responses, each of which is assigned a score ranging from 6 points (never) to 13 points (always). The Total 6-item Headache Impact Test (HIT-6) score across Months 5 and 6 is calculated by taking the 2-month average of total 6-item Headache Impact Test (HIT-6) scores over Months 5 and 6. Negative changes from Baseline in the HIT-6 score indicate improvement.
Baseline, Months 5-6
Huntsville
Alabama
35805-4046
United States
Alea Research /ID# 233329
Phoenix
Arizona
85012-2707
United States
Duplicate_Barrow Neurological Institute /ID# 231799
Phoenix
Arizona
85013-4407
United States
Clinical Endpoints /ID# 232625
Scottsdale
Arizona
85258-4595
United States
Tucson Neuroscience Research /ID# 232288
Tucson
Arizona
85710-6152
United States
Arkansas Clinical Research /ID# 231640
Little Rock
Arkansas
72205
United States
Woodland International Research Group /ID# 231492
Little Rock
Arkansas
72211
United States
Hope Clinical Research /ID# 232189
Canoga Park
California
91303
United States
Pharmacology Research Institute (PRI) - Encino (Wake) /ID# 231351
Encino
California
91316
United States
Duplicate_Neuro Pain Medical Center /ID# 231478
Fresno
California
93710-5473
United States
Sun Valley Research Center /ID# 231350
Imperial
California
92251-9401
United States
Wake Research - Pharmacology Research Institute (WR-PRI), LLC (Alamitos) /ID# 231908
Los Alamitos
California
90720
United States
Pharmacology Research Institute (PRI) - Newport Beach (Wake) /ID# 231337
Indywidualna Praktyka Lekarska dr hab. med. Anna Szczepanska-Szerej /ID# 232355
Lublin
Lublin Voivodeship
20-582
Poland
Warszawska Klinika Sp. z o.o. /ID# 240612
Warsaw
Masovian Voivodeship
02-119
Poland
Silmedic Sp. z o.o. /ID# 232358
Katowice
Silesian Voivodeship
40-282
Poland
MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak /ID# 241887
Wroclaw
52-210
Poland
Clinica Universidad de Navarra - Pamplona /ID# 232270
Pamplona
Navarre
31008
Spain
Hospital Universitario Central de Asturias /ID# 232428
Oviedo
Principality of Asturias
33011
Spain
Hospital Universitario Vall d'Hebron /ID# 232268
Barcelona
08035
Spain
CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 233320
Madrid
28027
Spain
Hospital Universitario La Paz /ID# 232495
Madrid
28046
Spain
Hospital Clinico Universitario de Valladolid /ID# 232272
Valladolid
47003
Spain
Skaneuro Privatmottagning /ID# 232175
Lund
Skåne County
227 33
Sweden
Neurology Clinic /ID# 234067
Stockholm
Stockholm County
114 33
Sweden
Optimuskliniken /ID# 232174
Upplands Vasby
194 61
Sweden
Linkoping University Hospital /ID# 234040
Linköping
Östergötland County
581 85
Sweden
Hull University Teaching Hospitals NHS Trust /ID# 242763
Hull
East Riding Of Yorkshire
HU3 2JZ
United Kingdom
Duplicate_Queen Elizabeth University Hospital /ID# 244870
Glasgow
Glasgow City
G51 4TF
United Kingdom
NHS Highland /ID# 242855
Inverness
IV2 3UJ
United Kingdom
Walton Centre /ID# 242857
Liverpool
L9 7LJ
United Kingdom
St Pancras Clinical Research /ID# 242764
London
EC2Y 8EA
United Kingdom
Participants randomized to receive placebo intramuscular injections in the head/neck muscles for BOTOX on Day 1 and Week 12.
FG002
Double-Blind Phase: BOTOX 155 U
Participants randomized to receive intramuscular injections in the head/neck muscles of BOTOX 155 U on Day 1 and Week 12.
FG003
Double-Blind Phase: BOTOX 195 U
Participants randomized to receive intramuscular injections in the head/neck muscles of BOTOX 195 U on Day 1 and Week 12.
FG004
Double-Blind Phase: Placebo/Open-Label Phase: BOTOX 195 U
Participants randomized to receive placebo for BOTOX intramuscular injections in the head/neck muscles on Day 1 and Week 12 during the Double-Blind Phase who then received intramuscular injections of BOTOX 195 U in the head/neck muscles on Weeks 24 and 36 in the Open-Label Phase.
FG005
Double-Blind Phase: BOTOX 155 U/Open-Label Phase: BOTOX 195 U
Participants randomized to receive intramuscular injections of BOTOX 155 U in the head/neck muscles on Day 1 and Week 12 during the Double-Blind Phase who then received intramuscular injections of BOTOX 195 U in the head/neck muscles on Weeks 24 and 36 in the Open-Label Phase.
FG006
Double-Blind Phase: BOTOX 195 U/Open-Label Phase: BOTOX 195 U
Participants randomized to receive intramuscular injections of BOTOX 195 U in the head/neck muscles on Day 1 and Week 12 during the Double-Blind Phase who then received intramuscular injections of BOTOX 195 U in the head/neck muscles on Weeks 24 and 36 in the Open-Label Phase.
FG000775 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
COMPLETED
FG000775 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
Double-Blind Phase
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG001257 subjects
FG002257 subjects
FG003261 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
Received at Least One Dose of Study Treatment
FG0000 subjects
FG001257 subjects
FG002256 subjects
FG003261 subjects
COMPLETED
FG0000 subjects
FG001217 subjects
FG002230 subjects
FG003223 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG00140 subjects
FG00227 subjects
FG00338 subjects
FG004
Type
Comment
Reasons
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Open-Label Phase
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004217 subjects
FG005230 subjects
FG006223 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Intent-to-Treat Population (as randomized)
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Double-Blind Phase: Placebo
Participants received placebo intramuscular injections in the head/neck muscles for BOTOX on Day 1 and Week 12.
BG001
Double-Blind Phase: BOTOX 155 U
Participants received intramuscular injections in the head/neck muscles of BOTOX 155 U on Day 1 and Week 12.
BG002
Double-Blind Phase: BOTOX 195 U
Participants received intramuscular injections in the head/neck muscles of BOTOX 195 U on Day 1 and Week 12.
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000257
BG001257
BG002261
BG003775
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00040.3± 11.12
BG00141.1± 10.37
BG00241.1± 10.76
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000231
BG001227
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG00024
BG00130
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0011
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Change From Baseline in the Frequency of Monthly Migraine Days Across Months 5 and 6
The frequency of monthly migraine days across Months 5 and 6 is calculated by taking the 2-month average of monthly migraine days over Months 5 and 6. Month 5 and Month 6 are the 28-day daily diary periods ending with Days 56 and Days 84 after the second study treatment intervention day with BOTOX or placebo injections, respectively. Negative changes from Baseline indicate improvement.
Intent-to-Treat Population (as Randomized); data used are "observed data" (without imputation for missing values)
Posted
Least Squares Mean
95% Confidence Interval
monthly migraine days
Baseline, Months 5-6
ID
Title
Description
OG000
Double-Blind Phase: Placebo
Participants received placebo intramuscular injections in the head/neck muscles for BOTOX on Day 1 and Week 12.
OG001
Double-Blind Phase: BOTOX 155 U
Participants received intramuscular injections in the head/neck muscles of BOTOX 155 U on Day 1 and Week 12.
OG002
Double-Blind Phase: BOTOX 195 U
Participants received intramuscular injections in the head/neck muscles of BOTOX 195 U on Day 1 and Week 12.
Units
Counts
Participants
OG000227
OG001234
OG002227
Title
Denominators
Categories
Title
Measurements
OG000-3.0(-3.55 to -2.46)
OG001-3.1(-3.65 to -2.57)
OG002-3.0(-3.51 to -2.43)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
BOTOX 195 U vs Placebo
Mixed Model for Repeated Measures (MMRM)
=0.914
LS Mean Difference
0.0
Standard Error of the Mean
0.33
2-Sided
95
-0.62
0.69
LS Mean Difference = BOTOX 195 U - Placebo
Superiority
P-value/95% CI obtained from mixed-effects model for repeated measures (MMRM) for primary analysis of the 2 visits across Months 5 and 6. Tx (BOTOX 195 U, 155 U, placebo), month (Months 1-6), country, strata of previous exposure to migraine prophylactic treatment, and Tx group-by-month interaction as fixed effects, with Baseline monthly migraine days as covariate, included as a continuous variable rather than the binomial stratification variable. Subject/residual errors are random effects.
Primary
Number of Participants With Treatment-Emergent Adverse Events (AEs)
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.
Safety Analysis Set: all participants who received any amount of study treatment; included in the analysis according to the study treatment that they actually received (as treated).
Participants received placebo intramuscular injections in the head/neck muscles for BOTOX on Day 1 and Week 12.
OG001
Double-Blind Phase: BOTOX 155 U
Secondary
Change From Baseline in the Frequency of Monthly Headache Days Across Months 5 and 6
The frequency of monthly headache days across Months 5 and 6 is calculated by taking the 2-month average of monthly headache days over Months 5 and 6. Month 5 and Month 6 are the 28-day daily diary periods ending with Days 56 and Days 84 after the second study treatment intervention day with BOTOX or placebo injections, respectively. Negative changes from Baseline indicate improvement.
Intent-to-Treat Population (as Randomized); data used are "observed data" (without imputation for missing values)
Posted
Least Squares Mean
95% Confidence Interval
monthly headache days
Baseline, Months 5-6
ID
Title
Description
OG000
Double-Blind Phase: Placebo
Participants received placebo intramuscular injections in the head/neck muscles for BOTOX on Day 1 and Week 12.
OG001
Double-Blind Phase: BOTOX 155 U
Participants received intramuscular injections in the head/neck muscles of BOTOX 155 U on Day 1 and Week 12.
OG002
Double-Blind Phase: BOTOX 195 U
Participants received intramuscular injections in the head/neck muscles of BOTOX 195 U on Day 1 and Week 12.
Secondary
Percentage of Participants With ≥ 50% Reduction From Baseline in the Frequency of Monthly Migraine Days Across Months 5 and 6
The frequency of monthly migraine days across Months 5 and 6 is calculated by taking the 2-month average of monthly migraine days over Months 5 and 6. Month 5 and Month 6 are the 28-day daily diary periods ending with Days 56 and Days 84 after the second study treatment intervention day with BOTOX or placebo injections, respectively. The responder status of 50% reduction from Baseline is defined as a participant with at least a 50% reduction from Baseline in the 2-month average of monthly migraine days over Months 5 and 6.
Intent-to-Treat Population (as Randomized); data used are "observed data" (without imputation for missing values)
Posted
Number
95% Confidence Interval
percentage of participants
Baseline, Months 5-6
ID
Title
Description
OG000
Double-Blind Phase: Placebo
Participants received placebo intramuscular injections in the head/neck muscles for BOTOX on Day 1 and Week 12.
OG001
Double-Blind Phase: BOTOX 155 U
Participants received intramuscular injections in the head/neck muscles of BOTOX 155 U on Day 1 and Week 12.
OG002
Double-Blind Phase: BOTOX 195 U
Secondary
Change From Baseline in the Frequency of Monthly Acute Headache Medication Days Across Months 5 and 6
Monthly acute headache medication days across Months 5 and 6 is calculated by taking the 2-month average of monthly acute headache medication days over Months 5 and 6. Month 5 and Month 6 are the 28-day daily diary periods ending with Days 56 and Days 84 after the second study treatment intervention day with BOTOX or placebo injections, respectively. Negative changes from Baseline indicate improvement.
Intent-to-Treat Population (as Randomized); data used are "observed data" (without imputation for missing values)
Posted
Least Squares Mean
95% Confidence Interval
Monthly Acute Headache Medication Days
Baseline, Months 5-6
ID
Title
Description
OG000
Double-Blind Phase: Placebo
Participants received placebo intramuscular injections in the head/neck muscles for BOTOX on Day 1 and Week 12.
OG001
Double-Blind Phase: BOTOX 155 U
Participants received intramuscular injections in the head/neck muscles of BOTOX 155 U on Day 1 and Week 12.
OG002
Double-Blind Phase: BOTOX 195 U
Participants received intramuscular injections in the head/neck muscles of BOTOX 195 U on Day 1 and Week 12.
Secondary
Change From Baseline in Migraine-Specific Quality of Life Questionnaire Version 2.1 (MSQ v2.1) Role Function - Restrictive (RFR) Domain Score At Month 6
The MSQ v2.1 is a 14-item questionnaire designed to measure health-related quality of life impairments attributed to migraine over the past 4 weeks. It is divided into 3 domains, and the Role Function Restrictive (RFR) assesses how migraines limit one's daily social and work-related activities using a 6-point scale ranging from "none of the time" to "all of the time". Raw dimension scores are computed as a sum of item responses and rescaled to a 0 to 100 scale, where higher scores indicate better quality of life. Positive changes from Baseline indicate improvement.
Intent-to-Treat Population (as Randomized); data used are "observed data" (without imputation for missing values)
Posted
Least Squares Mean
95% Confidence Interval
units on a scale
Baseline, Month 6
ID
Title
Description
OG000
Double-Blind Phase: Placebo
Participants received placebo intramuscular injections in the head/neck muscles for BOTOX on Day 1 and Week 12.
OG001
Double-Blind Phase: BOTOX 155 U
Participants received intramuscular injections in the head/neck muscles of BOTOX 155 U on Day 1 and Week 12.
OG002
Double-Blind Phase: BOTOX 195 U
Secondary
Change From Baseline in the Activity Impairment in Migraine - Diary (AIM-D) Physical Impairment Domain Score Across Months 5 and 6
AIM-D Physical Impairment Domain score is calculated based on the summation of AIM-D items 6-9. Participants answer each question based on the level of difficulty experienced in the 24 hours prior, with "during your headache" indicated for when they reported a headache, using a 6-point rating scale ranging from "not difficult at all" to "extremely difficult". The raw daily score is transformed to a 0-100 scale, and the monthly score is calculated using the average daily scores, where a higher score indicates worse physical impairment. AIM-D Physical Impairment domain score across Months 5 and 6 is calculated by taking the 2-month average of AIM-D Physical Impairment domain scores over Months 5 and 6. Month 5 and Month 6 are the 28-day daily diary periods ending with Days 56 and Days 84 after the second study treatment intervention day with BOTOX or placebo injections, respectively. Negative changes from Baseline indicate improvement.
Intent-to-Treat Population (as Randomized); data used are "observed data" (without imputation for missing values)
Posted
Least Squares Mean
95% Confidence Interval
units on a scale
Baseline, Months 5-6
ID
Title
Description
OG000
Double-Blind Phase: Placebo
Participants received placebo intramuscular injections in the head/neck muscles for BOTOX on Day 1 and Week 12.
OG001
Double-Blind Phase: BOTOX 155 U
Secondary
Change From Baseline in the Total 6-item Headache Impact Test (HIT-6) Score Across Months 5 and 6
The HIT-6 is a 6-item assessment used to measure the impact headaches have on a participant's ability to function on the job, at school, at home and in social situations. It assesses the effect that headaches have on normal daily life and the subject's ability to function. Responses are based on frequency using a 5-point scale ranging from "never" to "always." The HIT-6 total score, which ranges from 36 to 78, is the sum of the responses, each of which is assigned a score ranging from 6 points (never) to 13 points (always). The Total 6-item Headache Impact Test (HIT-6) score across Months 5 and 6 is calculated by taking the 2-month average of total 6-item Headache Impact Test (HIT-6) scores over Months 5 and 6. Negative changes from Baseline in the HIT-6 score indicate improvement.
Intent-to-Treat Population (as Randomized); data used are "observed data" (without imputation for missing values)
Posted
Least Squares Mean
95% Confidence Interval
units on a scale
Baseline, Months 5-6
ID
Title
Description
OG000
Double-Blind Phase: Placebo
Participants received placebo intramuscular injections in the head/neck muscles for BOTOX on Day 1 and Week 12.
OG001
Double-Blind Phase: BOTOX 155 U
Participants received intramuscular injections in the head/neck muscles of BOTOX 155 U on Day 1 and Week 12.
Time Frame
All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Description
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Screening/Baseline Phase
Participants with 6 to 14 migraine days and < 15 headache days per month in each of the 3 months prior to the screening visit (Visit 1) and during the 4-week Screening/Baseline Phase were randomized in this study.
0
775
2
775
14
775
EG001
Double-Blind Phase: Placebo
Participants received placebo intramuscular injections in the head/neck muscles for BOTOX on Day 1 and Week 12.
0
257
6
257
21
257
EG002
Double-Blind Phase: BOTOX 155 U
Participants received intramuscular injections in the head/neck muscles of BOTOX 155 U on Day 1 and Week 12.
0
256
3
256
35
256
EG003
Double-Blind Phase: BOTOX 195 U
Participants received intramuscular injections in the head/neck muscles of BOTOX 195 U on Day 1 and Week 12.
1
262
6
262
22
262
EG004
Double-Blind Phase: Placebo/Open-Label Phase: BOTOX 195 U
Participants who received placebo for BOTOX intramuscular injections in the head/neck muscles on Day 1 and Week 12 during the Double-Blind Phase who then received intramuscular injections of BOTOX 195 U in the head/neck muscles on Weeks 24 and 36 in the Open-Label Phase.
0
217
2
217
19
217
EG005
Double-Blind Phase: BOTOX 155 U/Open-Label Phase: BOTOX 195 U
Participants who received intramuscular injections of BOTOX 155 U in the head/neck muscles on Day 1 and Week 12 during the Double-Blind Phase who then received intramuscular injections of BOTOX 195 U in the head/neck muscles on Weeks 24 and 36 in the Open-Label Phase.
0
227
1
227
18
227
EG006
Double-Blind Phase: BOTOX 195 U/Open-Label Phase: BOTOX 195 U
Participants who received intramuscular injections of BOTOX 195 U in the head/neck muscles on Day 1 and Week 12 during the Double-Blind Phase who then received intramuscular injections of BOTOX 195 U in the head/neck muscles on Weeks 24 and 36 in the Open-Label Phase.
1
223
1
223
14
223
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
IMMUNE THROMBOCYTOPENIA
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected775 at risk
EG0010 events0 affected257 at risk
EG0020 events0 affected256 at risk
EG0031 events1 affected262 at risk
EG004
VESTIBULAR DISORDER
Ear and labyrinth disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected775 at risk
EG0010 events0 affected257 at risk
EG0020 events0 affected256 at risk
EG003
PORTOSPLENOMESENTERIC VENOUS THROMBOSIS
Hepatobiliary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected775 at risk
EG0010 events0 affected257 at risk
EG0020 events0 affected256 at risk
EG003
STAPHYLOCOCCAL ABSCESS
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected775 at risk
EG0010 events0 affected257 at risk
EG0020 events0 affected256 at risk
EG003
ANKLE FRACTURE
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected775 at risk
EG0010 events0 affected257 at risk
EG0020 events0 affected256 at risk
EG003
FALL
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected775 at risk
EG0011 events1 affected257 at risk
EG0020 events0 affected256 at risk
EG003
TRAUMATIC HAEMATOMA
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected775 at risk
EG0010 events0 affected257 at risk
EG0021 events1 affected256 at risk
EG003
INTERVERTEBRAL DISC PROTRUSION
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected775 at risk
EG0011 events1 affected257 at risk
EG0021 events1 affected256 at risk
EG003
LIPOSARCOMA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected775 at risk
EG0011 events1 affected257 at risk
EG0020 events0 affected256 at risk
EG003
MIGRAINE
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected775 at risk
EG0010 events0 affected257 at risk
EG0020 events0 affected256 at risk
EG003
MIGRAINE WITH AURA
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected775 at risk
EG0010 events0 affected257 at risk
EG0020 events0 affected256 at risk
EG003
MYELOPATHY
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected775 at risk
EG0011 events1 affected257 at risk
EG0020 events0 affected256 at risk
EG003
SCIATICA
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected775 at risk
EG0011 events1 affected257 at risk
EG0020 events0 affected256 at risk
EG003
COMPLETED SUICIDE
Psychiatric disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected775 at risk
EG0010 events0 affected257 at risk
EG0020 events0 affected256 at risk
EG003
BENIGN PROSTATIC HYPERPLASIA
Reproductive system and breast disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected775 at risk
EG0010 events0 affected257 at risk
EG0021 events1 affected256 at risk
EG003
BREAST HYPERPLASIA
Reproductive system and breast disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected775 at risk
EG0010 events0 affected257 at risk
EG0020 events0 affected256 at risk
EG003
DYSPNOEA
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected775 at risk
EG0010 events0 affected257 at risk
EG0020 events0 affected256 at risk
EG003
ABORTION INDUCED
Surgical and medical procedures
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected775 at risk
EG0011 events1 affected257 at risk
EG0020 events0 affected256 at risk
EG003
HYPERTENSION
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected775 at risk
EG0010 events0 affected257 at risk
EG0020 events0 affected256 at risk
EG003
LABILE BLOOD PRESSURE
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected775 at risk
EG0010 events0 affected257 at risk
EG0020 events0 affected256 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
COVID-19
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0004 events4 affected775 at risk
EG0019 events9 affected257 at risk
EG00216 events16 affected256 at risk
EG0038 events8 affected262 at risk
EG00412 events12 affected217 at risk
EG0059 events9 affected227 at risk
EG0067 events7 affected223 at risk
NASOPHARYNGITIS
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG00010 events10 affected775 at risk
EG00115 events14 affected257 at risk
EG00226 events23 affected256 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
Completed Double-Blind Phase and then withdrew from study
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0052 subjects
FG0060 subjects
Completed Double-Blind Phase and then withdrew due to pregnancy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
40.8
± 10.75
224
BG003682
Male
BG00026
BG00130
BG00237
BG00393
37
BG00391
Not Hispanic or Latino
BG000233
BG001227
BG002224
BG003684
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
0
BG0031
Asian
BG0003
BG0013
BG0027
BG00313
Native Hawaiian or Other Pacific Islander
BG0000
BG0011
BG0020
BG0031
Black or African American
BG00023
BG00112
BG00214
BG00349
White
BG000229
BG001240
BG002237
BG003706
More than one race
BG0002
BG0010
BG0022
BG0034
Unknown or Not Reported
BG0000
BG0010
BG0021
BG0031
OG000
OG001
BOTOX 155 U vs Placebo
Mixed Model for Repeated Measures (MMRM)
=0.745
LS Mean Difference
-0.1
Standard Error of the Mean
0.33
2-Sided
95
-0.76
0.55
LS Mean Difference = BOTOX 155 U - Placebo
Superiority
P-value/95% CI obtained from mixed-effects model for repeated measures (MMRM) for primary analysis of the 2 visits across Months 5 and 6. Tx (BOTOX 195 U, 155 U, placebo), month (Months 1-6), country, strata of previous exposure to migraine prophylactic treatment, and Tx group-by-month interaction as fixed effects, with Baseline monthly migraine days as covariate, included as a continuous variable rather than the binomial stratification variable. Subject/residual errors are random effects.
Participants received intramuscular injections in the head/neck muscles of BOTOX 155 U on Day 1 and Week 12.
OG002
Double-Blind Phase: BOTOX 195 U
Participants received intramuscular injections in the head/neck muscles of BOTOX 195 U on Day 1 and Week 12.
OG003
Double-Blind Phase: Placebo/Open-Label Phase: BOTOX 195 U
Participants who received placebo for BOTOX intramuscular injections in the head/neck muscles on Day 1 and Week 12 during the Double-Blind Phase who then received intramuscular injections of BOTOX 195 U in the head/neck muscles on Weeks 24 and 36 in the Open-Label Phase.
OG004
Double-Blind Phase: BOTOX 155 U/Open-Label Phase: BOTOX 195 U
Participants who received intramuscular injections of BOTOX 155 U in the head/neck muscles on Day 1 and Week 12 during the Double-Blind Phase who then received intramuscular injections of BOTOX 195 U in the head/neck muscles on Weeks 24 and 36 in the Open-Label Phase.
OG005
Double-Blind Phase: BOTOX 195 U/Open-Label Phase: BOTOX 195 U
Participants who received intramuscular injections of BOTOX 195 U in the head/neck muscles on Day 1 and Week 12 during the Double-Blind Phase who then received intramuscular injections of BOTOX 195 U in the head/neck muscles on Weeks 24 and 36 in the Open-Label Phase.
Units
Counts
Participants
OG000257
OG001255
OG002262
OG003217
OG004225
OG005223
Title
Denominators
Categories
Any TEAE
Title
Measurements
OG000106
OG001117
OG002120
OG00376
OG00475
OG00580
TESAE
Title
Measurements
OG0006
OG0013
OG0026
OG003
Units
Counts
Participants
OG000227
OG001234
OG002227
Title
Denominators
Categories
Title
Measurements
OG000-3.2(-3.77 to -2.59)
OG001-3.1(-3.71 to -2.54)
OG002-2.9(-3.46 to -2.29)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
BOTOX 195 U vs Placebo
Mixed Model for Repeated Measures (MMRM)
=0.414
LS Mean Difference
0.3
Standard Error of the Mean
0.36
2-Sided
95
-0.42
1.01
LS Mean Difference = BOTOX 195 U - Placebo
Superiority
P-value/95% CI obtained from mixed-effects model for repeated measures (MMRM) for primary analysis of the 2 visits across Months 5 and 6. Tx (BOTOX 195 U, 155 U, placebo), month (Months 1-6), country, strata of previous exposure to migraine prophylactic treatment, and Tx group-by-month interaction as fixed effects, with Baseline monthly headache days as covariate, included as a continuous variable. Subject/residual errors are random effects.
OG000
OG001
BOTOX 155 U vs Placebo
Mixed Model for Repeated Measures (MMRM)
=0.889
LS Mean Difference
0.1
Standard Error of the Mean
0.36
2-Sided
95
-0.66
0.76
LS Mean Difference = BOTOX 155 U - Placebo
Superiority
P-value/95% CI obtained from mixed-effects model for repeated measures (MMRM) for primary analysis of the 2 visits across Months 5 and 6. Tx (BOTOX 195 U, 155 U, placebo), month (Months 1-6), country, strata of previous exposure to migraine prophylactic treatment, and Tx group-by-month interaction as fixed effects, with Baseline monthly headache days as covariate, included as a continuous variable. Subject/residual errors are random effects.
Participants received intramuscular injections in the head/neck muscles of BOTOX 195 U on Day 1 and Week 12.
Units
Counts
Participants
OG000227
OG001234
OG002227
Title
Denominators
Categories
Title
Measurements
OG00044.9(38.35 to 51.66)
OG00146.2(39.64 to 52.77)
OG00247.1(40.50 to 53.85)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
BOTOX 195 U vs Placebo
Regression, Logistic
=0.451
Response Rate Difference
2.2
2-Sided
95
-7.08
11.46
Response Rate Difference = BOTOX 195 U - Placebo
Superiority
P-value is obtained from Logistic Regression. Model includes treatment (BOTOX 195 U, BOTOX 155 U, and placebo), country and strata of previous exposure to migraine prophylactic treatment as fixed effects, with the Baseline monthly migraine days as a covariate, included as a continuous variable. Subject and residual errors are random effects in this by visit logistic covariate analysis of variance (ANCOVA). Confidence intervals (Clopper-Pearson) are based on binomial-distribution assumptions.
OG000
OG001
BOTOX 155 U vs Placebo
Regression, Logistic
=0.762
Response Rate Difference
1.2
2-Sided
95
-7.94
10.40
Response Rate Difference = BOTOX 155 U - Placebo
Superiority
P-value is obtained from Logistic Regression. Model includes treatment (BOTOX 195 U, BOTOX 155 U, and placebo), country and strata of previous exposure to migraine prophylactic treatment as fixed effects, with the Baseline monthly migraine days as a covariate, included as a continuous variable. Subject and residual errors are random effects in this by visit logistic covariate analysis of variance (ANCOVA). Confidence intervals (Clopper-Pearson) are based on binomial-distribution assumptions.
Units
Counts
Participants
OG000227
OG001234
OG002227
Title
Denominators
Categories
Title
Measurements
OG000-2.0(-2.47 to -1.47)
OG001-1.9(-2.44 to -1.44)
OG002-1.8(-2.34 to -1.35)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
BOTOX 195 U vs Placebo
Mixed Model for Repeated Measures (MMRM)
=0.686
LS Mean Difference
0.1
Standard Error of the Mean
0.31
2-Sided
95
-0.48
0.74
LS Mean Difference = BOTOX 195 U - Placebo
Superiority
P-value/95% CI obtained from mixed-effects model for repeated measures (MMRM) for primary analysis of the 2 visits across Months 5 and 6. Tx (BOTOX 195 U, BOTOX 155 U, placebo), month (Months 1-6), country, strata of previous exposure to migraine prophylactic treatment, and Tx group-by-month interaction as fixed effects, with the Baseline monthly acute headache medication days as a covariate, included as a continuous variable. Subject and residual errors are random effects.
OG000
OG001
BOTOX 155 U vs Placebo
Mixed Model for Repeated Measures (MMRM)
=0.913
LS Mean Difference
0.0
Standard Error of the Mean
0.31
2-Sided
95
-0.57
0.64
LS Mean Difference = BOTOX 155 U - Placebo
Superiority
P-value/95% CI obtained from mixed-effects model for repeated measures (MMRM) for primary analysis of the 2 visits across Months 5 and 6. Tx (BOTOX 195 U, BOTOX 155 U, placebo), month (Months 1-6), country, strata of previous exposure to migraine prophylactic treatment, and Tx group-by-month interaction as fixed effects, with the Baseline monthly acute headache medication days as a covariate, included as a continuous variable. Subject and residual errors are random effects.
Participants received intramuscular injections in the head/neck muscles of BOTOX 195 U on Day 1 and Week 12.
Units
Counts
Participants
OG000216
OG001228
OG002218
Title
Denominators
Categories
Title
Measurements
OG00018.6(15.77 to 21.51)
OG00119.4(16.58 to 22.27)
OG00219.0(16.15 to 21.87)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
BOTOX 195 U vs Placebo
Mixed Model for Repeated Measures (MMRM)
=0.837
LS Mean Difference
0.4
Standard Error of the Mean
1.81
2-Sided
95
-3.18
3.93
LS Mean Difference = BOTOX 195 U - Placebo
Superiority
P-value/95% CI obtained from mixed-effects model for repeated measures (MMRM) for primary analysis of the visit at Month 6. Tx (BOTOX 195 U, BOTOX 155 U, placebo), month (Months 1-6), country, strata of previous exposure to migraine prophylactic treatment, and Tx group-by-month interaction as fixed effects, with the Baseline MSQ v2.1 RFR Domain Score as a covariate, included as a continuous variable. Subject and residual errors are random effects.
OG000
OG001
BOTOX 155 U vs Placebo
Mixed Model for Repeated Measures (MMRM)
=0.662
LS Mean Difference
0.8
Standard Error of the Mean
1.79
2-Sided
95
-2.74
4.31
LS Mean Difference = BOTOX 155 U - Placebo
Superiority
P-value/95% CI obtained from mixed-effects model for repeated measures (MMRM) for primary analysis of the visit at Month 6. Tx (BOTOX 195 U, BOTOX 155 U, placebo), month (Months 1-6), country, strata of previous exposure to migraine prophylactic treatment, and Tx group-by-month interaction as fixed effects, with the Baseline MSQ v2.1 RFR Domain Score as a covariate, included as a continuous variable. Subject and residual errors are random effects.
Participants received intramuscular injections in the head/neck muscles of BOTOX 155 U on Day 1 and Week 12.
OG002
Double-Blind Phase: BOTOX 195 U
Participants received intramuscular injections in the head/neck muscles of BOTOX 195 U on Day 1 and Week 12.
Units
Counts
Participants
OG000225
OG001232
OG002222
Title
Denominators
Categories
Title
Measurements
OG000-5.0(-6.23 to -3.82)
OG001-4.6(-5.82 to -3.39)
OG002-4.9(-6.07 to -3.66)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
BOTOX 195 U vs Placebo
Mixed Model for Repeated Measures (MMRM)
=0.834
LS Mean Difference
0.2
Standard Error of the Mean
0.75
2-Sided
95
-1.32
1.63
LS Mean Difference = BOTOX 195 U - Placebo
Superiority
P-value/95% CI are obtained from mixed-effects model for repeated measures (MMRM) analysis for primary analysis of the 2 visits across Months 5 and 6. Tx (BOTOX 195 U, BOTOX 155 U, placebo), month (Months 1-6), country, strata of previous exposure to migraine prophylactic treatment, and Tx group-by-month interaction as fixed effects, with the Baseline AIM-D Physical Impairment domain score as a covariate, included as a continuous variable. Subject and residual errors are random effects.
OG000
OG001
BOTOX 155 U vs Placebo
Mixed Model for Repeated Measures (MMRM)
=0.578
LS Mean Difference
0.4
Standard Error of the Mean
0.75
2-Sided
95
-1.06
1.90
LS Mean Difference = BOTOX 155 U - Placebo
Superiority
P-value/95% CI are obtained from mixed-effects model for repeated measures (MMRM) analysis for primary analysis of the 2 visits across Months 5 and 6. Tx (BOTOX 195 U, BOTOX 155 U, placebo), month (Months 1-6), country, strata of previous exposure to migraine prophylactic treatment, and Tx group-by-month interaction as fixed effects, with the Baseline AIM-D Physical Impairment domain score as a covariate, included as a continuous variable. Subject and residual errors are random effects.
OG002
Double-Blind Phase: BOTOX 195 U
Participants received intramuscular injections in the head/neck muscles of BOTOX 195 U on Day 1 and Week 12.
Units
Counts
Participants
OG000228
OG001238
OG002229
Title
Denominators
Categories
Title
Measurements
OG000-6.2(-7.26 to -5.08)
OG001-6.9(-7.94 to -5.77)
OG002-6.5(-7.62 to -5.45)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
BOTOX 195 U vs Placebo
Mixed Model for Repeated Measures (MMRM)
=0.589
LS Mean Difference
-0.4
Standard Error of the Mean
0.68
2-Sided
95
-1.69
0.96
LS Mean Difference = BOTOX 195 U - Placebo
Superiority
P-value/95% CI are obtained from a mixed-effects model for repeated measures (MMRM) analysis for primary analysis of the 2 visits across Months 5 and 6. Tx (BOTOX 195 U, BOTOX 155 U, placebo), month (Months 1-6), country, strata of previous exposure to migraine prophylactic treatment, and Tx group-by-month interaction as fixed effects, with the Baseline total HIT-6 score as a covariate, included as a continuous variable. Subject and residual errors are random effects.
OG000
OG001
BOTOX 155 U vs Placebo
Mixed Model for Repeated Measures (MMRM)
=0.310
LS Mean Difference
-0.7
Standard Error of the Mean
0.67
2-Sided
95
-2.00
0.64
LS Mean Difference = BOTOX 155 U - Placebo
Superiority
P-value/95% CI are obtained from a mixed-effects model for repeated measures (MMRM) analysis for primary analysis of the 2 visits across Months 5 and 6. Tx (BOTOX 195 U, BOTOX 155 U, placebo), month (Months 1-6), country, strata of previous exposure to migraine prophylactic treatment, and Tx group-by-month interaction as fixed effects, with the Baseline total HIT-6 score as a covariate, included as a continuous variable. Subject and residual errors are random effects.