Study of BOTOX Injections in Prevention of Migraine in Adult Participants With Episodic Migraine
Status:
Recruiting
Trial end date:
2023-11-26
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
Allergan
Treatments:
abobotulinumtoxinA Botulinum Toxins Botulinum Toxins, Type A