A Study Using Botulinum Toxin Type A as Headache Prophylaxis in Adolescents with Chronic Migraine


About this study

To evaluate the efficacy and safety of Botulinum Toxin Type A versus placebo (normal saline) as headache prophylaxis in adolescents (children 12 to 17) with chronic migraine.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Medical history of chronic migraine for at least 6 months
  • 15 or more headache days during a 4 week period

Exclusion Criteria:

  • Previous use of any botulinum toxin of any serotype for any reason
  • Diagnosis of Myasthenia gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis
  • Treatment of headache using acupuncture, transcutaneous electrical stimulation (TENS), cranial traction, dental splints, or injection of anesthetics/steroids within 4 weeks prior to the week -4 screening visit
  • Use of any headache prophylaxis medication within 4 weeks prior to the week -4 screening visit

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Kenneth Mack, M.D., Ph.D.

Closed for enrollment

More information


Publications are currently not available

Additional contact information

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