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

PHASE2CompletedINTERVENTIONAL
Enrollment

17

Participants

Timeline

Start Date

March 1, 2017

Primary Completion Date

November 30, 2018

Study Completion Date

April 20, 2020

Conditions
Migraine DisordersHeadache, MigrainePediatrics
Interventions
DRUG

OnabotulinumtoxinA

The AB subject group will receive OnabotulinumtoxinA in the first treatment and saline placebo in the second.Both groups will then receive OnabotulinumtoxinA in the last two treatments. There will be one treatment at the beginning of each 12 week block, meaning 4 treatments over the 48 week study period total. Progress check-ups will occur every 6 weeks during the study. Randomization will be via selection of sealed envelope.

OTHER

Placebo (Saline)

The BA subject group will receive saline and then Onabotulinumtoxin. A.Both groups will then receive OnabotulinumtoxinA in the last two treatments. There will be one treatment at the beginning of each 12 week block, meaning 4 treatments over the 48 week study period total. Progress check-ups will occur every 6 weeks during the study. Randomization will be via selection of sealed envelope.

Trial Locations (2)

92697

Gottschalk Medical Plaza, Irvine

92868

UC Irvine Medical Center, Orange

All Listed Sponsors
collaborator

American Society of Regional Anesthesia

OTHER

lead

University of California, Irvine

OTHER

NCT03055767 - Effectiveness of Onabotulinumtoxin A (Botox) in Pediatric Patients Experiencing Migraines: A Study in the Pediatric Pain Population | Biotech Hunter | Biotech Hunter