Study of BOTOX Injections in Prevention of Migraine in Adult Participants With Episodic Migraine

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Episodic Migraine

In brief

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.

Key facts

Study ID

NCT05028569

Run by

AbbVie

People needed

775

Starts

2021-11-05

Expected to finish

2024-11-06

Last updated by the study team

2025-12-09

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Neurology and Neurodiagnostics of Alabama /ID# 231918 — Hoover, Alabama, United States
• Rehabilitation & Neurological Services /ID# 252441 — Huntsville, Alabama, United States
• Alea Research /ID# 233329 — Phoenix, Arizona, United States
• Duplicate_Barrow Neurological Institute /ID# 231799 — Phoenix, Arizona, United States
• Clinical Endpoints /ID# 232625 — Scottsdale, Arizona, United States
• Tucson Neuroscience Research /ID# 232288 — Tucson, Arizona, United States
• Arkansas Clinical Research /ID# 231640 — Little Rock, Arkansas, United States
• Woodland International Research Group /ID# 231492 — Little Rock, Arkansas, United States
• Hope Clinical Research /ID# 232189 — Canoga Park, California, United States
• Pharmacology Research Institute (PRI) - Encino (Wake) /ID# 231351 — Encino, California, United States
• Duplicate_Neuro Pain Medical Center /ID# 231478 — Fresno, California, United States
• Sun Valley Research Center /ID# 231350 — Imperial, California, United States
• Wake Research - Pharmacology Research Institute (WR-PRI), LLC (Alamitos) /ID# 231908 — Los Alamitos, California, United States
• Pharmacology Research Institute (PRI) - Newport Beach (Wake) /ID# 231337 — Newport Beach, California, United States
• Colorado Springs Neurological Associates (CSNA) /ID# 230662 — Colorado Springs, Colorado, United States
• Summit Headache and Neurologic Institute /ID# 231809 — Englewood, Colorado, United States
• Advanced Neurosciences Research, LLC /ID# 230658 — Fort Collins, Colorado, United States
• Georgetown University Hospital /ID# 232129 — Washington D.C., District of Columbia, United States
• Neurology Offices of South Florida, PLLC /ID# 232281 — Boca Raton, Florida, United States
• Nova Clinical Research, LLC /ID# 245256 — Bradenton, Florida, United States
• Velocity Clinical Research - Hallandale Beach /ID# 232442 — Hallandale, Florida, United States
• CNS Healthcare - Jacksonville /ID# 231345 — Jacksonville, Florida, United States
• Brainstorm Research /ID# 243825 — Miami, Florida, United States
• Sensible Healthcare /ID# 231340 — Ocoee, Florida, United States
• M3 Wake Research Inc. /ID# 232285 — Raleigh, North Carolina, United States

Full record on ClinicalTrials.gov

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