NCT05028569

Study of BOTOX Injections in Prevention of Migraine in Adult Participants 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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 775 (actual)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Episodic Migraine

Interventions

Type	Name	Description
DRUG	BOTOX	Intramuscular Injection
DRUG	Placebo	Intramuscular Injection

Timeline

• Start date: 2021-11-05
• Primary completion: 2024-11-06
• Completion: 2024-11-06
• First posted: 2021-08-31
• Last updated: 2025-12-09
• Results posted: 2025-12-09

Locations

133 sites across 9 countries: United States, Canada, Czechia, Germany, Israel, Poland, Spain, Sweden, United Kingdom

Regulatory

• FDA-regulated drug study