Effectiveness of Onabotulinumtoxin A (Botox) in Pediatric Patients Experiencing Migraines: A Study in the Pediatric Pain Population

Completed · Phase 2 · Has a placebo group

Conditions studied: Migraine Disorders, Headache, Migraine, Pediatrics

In brief

The purpose of the research is to examine the outcomes of pediatric patients receiving Botulinum toxin type A (Botox ®) for the treatment of migraine. There is limited literature on the effectiveness of Botox ® in the treatment of chronic neurological pain in pediatric patients, specifically in the treatment of migraines.

Key facts

Study ID

NCT03055767

Run by

University of California, Irvine

People needed

17

Starts

2017-03-01

Expected to finish

2020-04-20

Last updated by the study team

2023-10-18

Who can join

Age: 8 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Children aged 8 - 17 years of age with a history of migraine meeting the criteria established in ICHD-II (2004), Section 1. Patients will provide at least 28-day baseline data in the form in the daily diary and must have at least 15 days of reported headache during this period, with at least 4 distinct episodes lasting at least 4 hours each.

You may not qualify if…

• Previous use of botulinum toxin of any serotype for any reason
• Pregnancy.
• 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 of screening visit

Where it is running

• Gottschalk Medical Plaza — Irvine, California, United States
• UC Irvine Medical Center — Orange, California, United States

Full record on ClinicalTrials.gov

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