Brief Summary
Migraine is a neurological disease characterized by moderate or severe headache, associated with nausea, vomiting, and/or sensitivity to light and sound (ICHD 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 Week 0 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.
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 Week 0 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.
Brief Title
Study of BOTOX Injections in Prevention of Migraine in Adult Participants With Episodic Migraine
Categories
Completion Date
Completion Date Type
Actual
Conditions
Episodic Migraine
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.
* 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.
Inclusion 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.
* 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.
Gender
All
Gender Based
false
Keywords
Migraine
Episodic Migraine
BOTOX
Botulinum Toxin Type A
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
65 Years
Minimum Age
18 Years
NCT Id
NCT05028569
Org Class
Industry
Org Full Name
AbbVie
Org Study Id
M21-307
Overall Status
Completed
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Actual
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
Primary Outcomes
Outcome Description
Change from baseline in the frequency of monthly migraine days (i.e., migraine or probable migraine headache days) will be assessed.
Outcome Measure
Change From Baseline in the Frequency of Monthly Migraine Days
Outcome Time Frame
6 Months
Outcome Description
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Outcome Measure
Number of Participants with Treatment Emergent Adverse Events (AEs)
Outcome Time Frame
Up to approximately 52 weeks
Secondary Ids
Secondary Id
2021-001979-16
Secondary Outcomes
Outcome Description
Change from baseline in the frequency of monthly headache days will be assessed.
Outcome Time Frame
6 Months
Outcome Measure
Change From Baseline in the Frequency of Monthly Headache Days
Outcome Description
Percentage of participants achieving 50% reduction from baseline in the frequency of monthly migraine days will be assessed.
Outcome Time Frame
6 Months
Outcome Measure
Responder Status of 50% Reduction From Baseline in the Frequency of Monthly Migraine Days
Outcome Description
The change from baseline in acute migraine medication use days will be assessed.
Outcome Time Frame
6 Months
Outcome Measure
Change From Baseline in the Frequency of Monthly Acute Headache Medication Days
Outcome Description
Role Function Restrictive (RFR) domain 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".
Outcome Time Frame
6 Months
Outcome Measure
Change From Baseline in Migraine-Specific Quality of Life Questionnaire version 2.1 (MSQ v2.1) Role Function - Restrictive (RFR) Domain Score
Outcome Description
AIM-D Physical impairment Domain Score asks participants to rate the level of difficulty experienced with physical impairment using a 6-point rating scale ranging from "not difficult at all" to "I could not do it at all".
Outcome Time Frame
6 Months
Outcome Measure
Change From Baseline in the Activity Impairment in Migraine - Diary (AIM-D) Physical Impairment Domain Score
See Also Links
Url
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
65
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Jelena Pavlovic
Investigator Email
jpavlovi@montefiore.org
Categories Mesh Debug
Brain, Spinal Cord & Nervous System --- MIGRAINE DISORDERS
Headaches & Migraine --- MIGRAINE DISORDERS
Brain, Spinal Cord & Nervous System --- HEADACHE DISORDERS, PRIMARY
Headaches & Migraine --- HEADACHE DISORDERS, PRIMARY
Brain, Spinal Cord & Nervous System --- HEADACHE DISORDERS
Headaches & Migraine --- HEADACHE DISORDERS
Alzheimer's --- BRAIN DISEASES
Brain, Spinal Cord & Nervous System --- BRAIN DISEASES
Brain, Spine & Nerve Cancers --- BRAIN DISEASES
Alzheimer's --- CENTRAL NERVOUS SYSTEM DISEASES
Brain, Spinal Cord & Nervous System --- CENTRAL NERVOUS SYSTEM DISEASES
Brain, Spine & Nerve Cancers --- CENTRAL NERVOUS SYSTEM DISEASES
Brain, Spinal Cord & Nervous System --- NERVOUS SYSTEM DISEASES
Brain, Spine & Nerve Cancers --- NERVOUS SYSTEM DISEASES
MeSH Terms
MIGRAINE DISORDERS
HEADACHE DISORDERS, PRIMARY
HEADACHE DISORDERS
BRAIN DISEASES
CENTRAL NERVOUS SYSTEM DISEASES
NERVOUS SYSTEM DISEASES
BOTULINUM TOXINS, TYPE A
COUNTERFEIT DRUGS
BOTULINUM TOXINS
METALLOENDOPEPTIDASES
ENDOPEPTIDASES
PEPTIDE HYDROLASES
HYDROLASES
ENZYMES
ENZYMES AND COENZYMES
METALLOPROTEASES
BACTERIAL PROTEINS
PROTEINS
AMINO ACIDS, PEPTIDES, AND PROTEINS
BACTERIAL TOXINS
TOXINS, BIOLOGICAL
BIOLOGICAL FACTORS
SUBSTANDARD DRUGS
PHARMACEUTICAL PREPARATIONS