Study of BOTOX Injections in Prevention of Migraine in Adult Participants With Episodic Migraine

Phase 3

Completed

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Double-Blind, Placebo-Controlled Phase: Placebo	Placebo	Participants will receive placebo on Week 0 and Week 12.
Double-Blind, Placebo-Controlled Phase: BOTOX Dose A	BOTOX	Participants will receive BOTOX Dose A on Week 0 and Week 12.
Double-Blind, Placebo-Controlled Phase: Placebo	BOTOX	Participants will receive placebo on Week 0 and Week 12.
Double-Blind, Placebo-Controlled Phase: BOTOX Dose B	BOTOX	Participants will receive BOTOX Dose B on Week 0 and Week 12.
Open-Label Phase: BOTOX Dose A	BOTOX	Eligible participants will receive BOTOX Dose A on Week 24 and Week 36.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in the Frequency of Monthly Migraine Days	6 Months	Change from baseline in the frequency of monthly migraine days (i.e., migraine or probable migraine headache days) will be assessed.
Number of Participants with Treatment Emergent Adverse Events (AEs)	Up to approximately 52 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Migraine-Specific Quality of Life Questionnaire version 2.1 (MSQ v2.1) Role Function - Restrictive (RFR) Domain Score	6 Months	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".
Change From Baseline in the Activity Impairment in Migraine - Diary (AIM-D) Physical Impairment Domain Score	6 Months	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".
Change From Baseline in the Frequency of Monthly Headache Days	6 Months	Change from baseline in the frequency of monthly headache days will be assessed.
Responder Status of 50% Reduction From Baseline in the Frequency of Monthly Migraine Days	6 Months	Percentage of participants achieving 50% reduction from baseline in the frequency of monthly migraine days will be assessed.
Change From Baseline in the Frequency of Monthly Acute Headache Medication Days	6 Months	The change from baseline in acute migraine medication use days will be assessed.

Locations (133): Neurology and Neurodiagnostics of Alabama /ID# 231918
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Hoover, Alabama, United States
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Scottsdale, Arizona, United States
Tucson Neuroscience Research /ID# 232288
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Tucson, Arizona, United States
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Little Rock, Arkansas, United States
Woodland International Research Group /ID# 231492
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Little Rock, Arkansas, United States
Hope Clinical Research /ID# 232189
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Canoga Park, California, United States
Pharmacology Research Institute (PRI) - Encino (Wake) /ID# 231351
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Neurology and Neurodiagnostics of Alabama /ID# 231918
🇺🇸Hoover, Alabama, United States