NCT05028569
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.
Interventional study
- 1
- 2
- 3
- 4
Age:
From 18 Years to 65 Years.
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.
