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
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
Migraine is a neurological disease characterized by moderate or severe headache, associated with nausea, vomiting, and/or sensitivity to light and sound (International Classification of Headache Disorders, 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 Day 1 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.
Inclusion Criteria:
Exclusion Criteria:
Encino, California 91316, United States
Los Alamitos, California 90720, United States
Newport Beach, California 92660, United States
Colorado Springs, Colorado 80907, United States
Washington D.C., District of Columbia 20007, United States
Hallandale, Florida 33009-4427, United States
West Palm Beach, Florida 33407-3209, United States
Indianapolis, Indiana 46256, United States
Ann Arbor, Michigan 48104-5131, United States
Burnsville, Minnesota 55337-6732, United States
Amherst, New York 14226, United States
Cincinnati, Ohio 45267-0585, United States
North Charleston, South Carolina 29405, United States
Falls Church, Virginia 22043-2367, United States
Virginia Beach, Virginia 23456-0019, United States
Lublin, Lublin Voivodeship 20-582, Poland
Hull, East Riding Of Yorkshire HU3 2JZ, United Kingdom
Glasgow, Glasgow City G51 4TF, United Kingdom