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

AbbVie

Status and phase: Completed; Phase 3

Conditions: Episodic Migraine

Treatments: Drug: Placebo; Drug: BOTOX

Study type: Interventional

Funder types: Industry

Identifiers

NCT05028569

M21-307

2021-001979-16 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 775 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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775 participants in 4 patient groups, including a placebo group

Double-Blind, Placebo-Controlled Phase: BOTOX Dose A

Experimental group

Description:

Participants will receive BOTOX Dose A on Week 0 and Week 12.

Treatment:

Drug: BOTOX

Double-Blind, Placebo-Controlled Phase: BOTOX Dose B

Experimental group

Description:

Participants will receive BOTOX Dose B on Week 0 and Week 12.

Treatment:

Drug: BOTOX

Double-Blind, Placebo-Controlled Phase: Placebo

Placebo Comparator group

Description:

Participants will receive placebo on Week 0 and Week 12.

Treatment:

Drug: BOTOX

Drug: Placebo

Open-Label Phase: BOTOX Dose A

Experimental group

Description:

Eligible participants will receive BOTOX Dose A on Week 24 and Week 36.

Treatment:

Drug: BOTOX