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

  • End date
    Nov 25, 2023
  • participants needed
  • sponsor
Updated on 27 October 2022


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.

Condition Episodic Migraine
Treatment Placebo, Botox
Clinical Study IdentifierNCT05028569
Last Modified on27 October 2022


Yes No Not Sure

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, tension-type headache, trigeminal autonomic cephalalgias, hypnic headache, hemicrania continua, or new daily persistent headache
History of headache attributed to another disorder (eg, secondary headaches), except medication overuse headache
History of an inadequate response to >4 medications (2 of which have different mechanisms of action) prescribed for the prevention of migraine
Pregnant or nursing females
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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