Condition: Migraine · Sponsor: AbbVie
Migraine is a common neurological disorder typically characterized by attacks of throbbing, moderate to severe headache, often associated with nausea, vomiting, and sensitivity to light and sound. Migraine is extremely common and disabling in children. The purpose of this study is to evaluate how safe and effective ubrogepant is in the acute treatment of migraine in children and adolescents. Ubrogepant is a drug approved for the acute treatment of migraine in adults. Children and adolescents (aged 6-17 years) with a history of migraine will be enrolled. The study will include 2 cohorts of participants - PK Cohort and Main Study (non-PK cohort). Participants aged 6-11 years in the PK Cohort will receive Dose A or Dose B of Ubrogepant for PK analysis to determine dose selection for the main study. In the main study, after dose selection, children aged 6-11 years will be randomized to receive either low or high dose of Ubrogepant or placebo. There is a 1 in 3 chance that a participant will be assigned to placebo. Adolescents aged 12-17 years will be randomized to receive either low or high dose of Ubrogepant or placebo with a 1 in 3 chance of placebo assignment. For qualifying migraine attacks, participants will receive oral tablets of the double-blind study intervention. There will be an option to take a second dose of double-blind study intervention (identical to initial dose), or rescue medication, at least 2 hours after the initial dose, for headache of moderate/severe int…
This description comes directly from the study's public registry record.
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| Rehabilitation & Neurological Services /ID# 229969 | Huntsville, Alabama, United States | Recruiting |
| The Center for Clinical Trials - Saraland /ID# 231546 | Saraland, Alabama, United States | Recruiting |
| Rezen Clinical Trials /ID# 282831 | Glendale, Arizona, United States | Not Yet Recruiting |
| Velocity Clinical Research - Phoenix /ID# 274478 | Phoenix, Arizona, United States | Recruiting |
| HealthStar Research Glenwood /ID# 275303 | Glenwood, Arkansas, United States | Recruiting |
| HealthStar Research of Hot Springs /ID# 273256 | Hot Springs, Arkansas, United States | Recruiting |
| Preferred Research Partners /ID# 230725 | Little Rock, Arkansas, United States | Recruiting |
| Advanced Research Center /ID# 227962 | Anaheim, California, United States | Recruiting |
| Neuro Pain Research Center /ID# 227966 | Fresno, California, United States | Recruiting |
| Alliance for Research Alliance for Wellness /ID# 230546 | Long Beach, California, United States | Recruiting |
| Children's Hospital Los Angeles /ID# 230596 | Los Angeles, California, United States | Completed |
| Excell Research, Inc /ID# 230899 | Oceanside, California, United States | Recruiting |
+ 117 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT05125302