Study to Assess Adverse Events and Disease Activity of Oral Ubrogepant Tablets for the Acute Treatment of Migraine in Children and Adolescents (Ages 6-17)
Migraine
About this trial
This is an interventional treatment trial for Migraine focused on measuring Migraine, Ubrogepant, Ubrelvy, PERISCOPE
Eligibility Criteria
Inclusion Criteria:
- A history of migraine with or without aura consistent with a diagnosis according to the International Classification of Headache Disorders (ICHD-3) for at least 6 months.
- By history, the participant's migraines typically last between 3 and 72 hours if untreated or treated unsuccessfully and migraine episodes are separated by at least 48 hours of headache pain freedom.
- History of 1 to 14 migraine attacks per month with moderate to severe headache in each of the 2 months prior to screening (Visit 1).
- Current or past use of at least 1 oral medication (over-the-counter medication or prescription medication) for the acute treatment of migraine.
- For main study participants, treatment of a qualifying migraine with single-blind placebo during the screening period and completion of 2-hour headache pain assessment.
- Weight is ≥ 20 kg (44 pounds) and < 135 kg (298 pounds)
- Per investigator judgment, participant is able to swallow or can learn to swallow study intervention.
- The participant is able to understand and complete the study questionnaires and eDiary. Participants who need assistance with reading the assessments may be assisted by a parent or guardian.
Exclusion Criteria:
- Any clinically significant hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal, cardiovascular or neurologic disease.
- In the opinion of the investigator, other confounding pain syndromes, confounding psychiatric conditions, or other significant neurological disorders other than migraine.
- History of malignancy in the 5 years prior to Visit 1.
- History of any prior gastrointestinal conditions (eg, diarrhea syndromes, inflammatory bowel disease) that may affect the absorption or metabolism of the study intervention.
- Significant risk of self-harm, based on clinical interview and responses on the Columbia-Suicide Severity Rating Scale (C-SSRS), or of harm to others; participants must be excluded if they report suicidal ideation with intent, with or without a plan, (ie, Type 4 or 5 on the C-SSRS) in the past 6 months or report suicidal behavior in the last 6 months prior to Visit 1 or Visit 2 assessments.
- At Visit 1, current alcohol or drug abuse or dependence per investigator's judgment.
- For main study participants, no headache at the 2-hour post dose assessment after taking single-blind placebo for a qualifying migraine during screening period (ie, placebo responder).
- A current diagnosis of chronic migraine as defined by ICHD-3
- Participants who overuse medication for migraine defined as use of opioids or barbiturates > 2 days/month, triptans or ergots ≥ 10 days/month, simple analgesics (eg, aspirin, NSAIDs, acetaminophen) ≥ 15 days/month or any combination of triptans, ergots, or simple analgesics (eg, aspirin, NSAIDs, acetaminophen) ≥ 10 days/month in the 3 months prior to Visit 1 per investigator's judgment.
- Difficulty distinguishing migraine headache from tension-type or other headaches.
- Has a history of migraine aura with diplopia or impairment of level of consciousness, hemiplegic migraine, or retinal migraine as defined by ICHD-3.
- Has a current diagnosis of new persistent daily headache, trigeminal autonomic cephalgia (eg, cluster headache), or painful cranial neuropathy as defined by ICHD-3
- Required in-hospital (excluding emergency department visits) treatment for migraines 3 or more times in the 6 months prior to Visit 1.
- Requirement for any medication (eg, barbiturates) or diet (eg, grapefruit juice) that is on the list of prohibited concomitant medications that cannot be discontinued or switched to an allowable, alternative medication at Visit 1.
- Previous exposure, within the last 6 months, to injectable monoclonal antibodies blocking the calcitonin gene-related peptide (CGRP) pathway
- History of hypersensitivity or clinically significant adverse reaction to a CGRP receptor antagonist or hypersensitivity to any component of the study interventions, ubrogepant or placebo.
- Currently participating or has participated in a study with an investigational compound or device within 30 days prior to Visit 1
Sites / Locations
- Rehabilitation & Neurological Services /ID# 229969Recruiting
- The Center for Clinical Trials - Saraland /ID# 231546Recruiting
- Preferred Research Partners /ID# 230725Recruiting
- Advanced Research Center /ID# 227962Recruiting
- Neuro Pain Medical Center /ID# 227966Recruiting
- Sunwise Clinical Research /ID# 230971Recruiting
- Alliance for Research - Long Beach /ID# 230546Recruiting
- Children's Hospital Los Angeles /ID# 230596Recruiting
- Excell Research, Inc /ID# 230899Recruiting
- Lumos Clinical Research Center /ID# 231267Recruiting
- Pacific Clinical Research Management Group /ID# 231636Recruiting
- Children's Hospital Colorado /ID# 231879Recruiting
- IMMUNOe Research Centers /ID# 230879Recruiting
- MCB Clinical Research Centers /ID# 231625Recruiting
- Emerson Clinical Research Inst /ID# 231693Recruiting
- Encore Medical Research of Boynton Beach LLC /ID# 246833Recruiting
- Gulfcoast Clinical Research Center /ID# 230020Recruiting
- Sarkis Clinical Trials /ID# 227956Recruiting
- Northwest Florida Clinical Research Group, LLC /ID# 231069Recruiting
- A.G.A Clinical Trials /ID# 230554Recruiting
- Encore Medical Research LLC /ID# 245682Recruiting
- Advanced Research Institute of Miami /ID# 230292Recruiting
- Auzmer Research /ID# 239251Recruiting
- Columbus Clinical Services, Llc /Id# 230880Recruiting
- My Preferred Research LLC /ID# 227886Recruiting
- Neurology & Pain Medicine /ID# 240168Recruiting
- Medical Research Group of Central Florida /ID# 231632Recruiting
- Suncoast Clinical Research - Palm Harbor /ID# 229337Recruiting
- Asclepes Research Centers - Spring Hill /ID# 229815Recruiting
- University of South Florida /ID# 229324Recruiting
- Encore Medical Research of Weston LLC /ID# 246809Recruiting
- Pediatrix Medical Group of Florida /ID# 229967Recruiting
- Rare Disease Research, LLC /ID# 231046Recruiting
- Clinical Integrative Research Center of Atlanta (CIRCA) /ID# 231134Recruiting
- Coastal Georgia Child Neurology /ID# 231409Recruiting
- CenExcel iResearch LLC /ID# 227903Recruiting
- Meridian Clinical Research LLC /ID# 228992Recruiting
- Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 231738Recruiting
- Velocity Clinical Research - Boise /ID# 231871Recruiting
- Chicago Headache Center & Research Institute /ID# 248625Recruiting
- Accellacare /ID# 229789Recruiting
- College Park Family Care Center Overland Park /ID# 231456Recruiting
- Psychiatric Associates /ID# 230872Recruiting
- Alliance for Multispecialty Research (AMR) - Wichita West /ID# 234126Recruiting
- Pharmasite Research, Inc. /ID# 227908Recruiting
- Minneapolis Clinic of Neurology - Burnsville /ID# 232551Recruiting
- MediSync Clinical Research Hattiesburg Clinic /ID# 233326Recruiting
- Proven Endpoints LLC /ID# 239513Recruiting
- Sharlin Health Neuroscience Research Center /ID# 229523Recruiting
- Cognitive Clinical Trials (CCT) - Papillion /ID# 232552Recruiting
- Healthy Perspectives - Innovative Mental Health Services, PLLC /ID# 230312Recruiting
- Hunterdon Neurology /ID# 245648Recruiting
- Goryeb Children's Hospital /ID# 229507Recruiting
- CVS HealthHUB - Runnemede /ID# 234233Recruiting
- Dent Neurosciences Research Center, Inc. /ID# 231182Recruiting
- Bioscience Research /ID# 232159Recruiting
- North Suffolk Neurology /ID# 230956Recruiting
- SUNY Upstate Medical University /ID# 239898Recruiting
- CVS HealthHUB - Charlotte /ID# 239530Recruiting
- OnSite Clinical Solutions, LLC - Hickory /ID# 227994Recruiting
- Patient Priority Clinical Sites, LLC /ID# 238485Recruiting
- Headache Center of Hope /ID# 242645Recruiting
- University of Cincinnati /ID# 231199Recruiting
- Centricity Research Columbus /ID# 231181Recruiting
- CincyScience /ID# 230046Recruiting
- IPS Research Company /ID# 227961
- Children's Hospital of Philadelphia - Main /ID# 232487Recruiting
- Frontier Clinical Research, LLC - Scottdale /ID# 231913Recruiting
- Frontier Clinical Research /ID# 231912Recruiting
- Coastal Pediatric Research /ID# 238616Recruiting
- Tribe Clinical Research LLC /ID# 230422Recruiting
- Premier Neurology, P.C. /ID# 227999
- Access Clinical Trials, Inc. /ID# 228002Recruiting
- BioBehavioral Research of Austin /ID# 230529Recruiting
- Tekton Research - Beaumont /ID# 231207Recruiting
- Velocity Clinical Research - Austin /ID# 230557Recruiting
- Relaro Medical Trials /ID# 239642Recruiting
- Cedar Health Research /ID# 228003Recruiting
- 3A Research - East El Paso /ID# 239193Recruiting
- Earle Research /ID# 231548Recruiting
- DM Clinical Research /ID# 229826Recruiting
- Houston Clinical Research Associates /ID# 244889Recruiting
- Sante Clinical Research /ID# 246503Recruiting
- FMC Science /ID# 231915Recruiting
- Livingspring Family Medical Center /ID# 249869Recruiting
- AIM Trials /ID# 230142Recruiting
- Road Runner Research /ID# 230527Recruiting
- Family Psychiatry of The Woodlands /ID# 230163Recruiting
- ClinPoint Trials /ID# 230295Recruiting
- Pantheon Clinical Research /ID# 250703Recruiting
- Highland Clinical Research /ID# 239362Recruiting
- Neuropsychiatric Associates LLC/DBA Woodstock Research Center /ID# 238976
- Office of Maria Ona /ID# 234232Recruiting
- Children's Hospital of The King's Daughters - Children's Medical Tower /ID# 230581Recruiting
- National Clinical Research /ID# 231320Recruiting
- Core Clinical Research /ID# 227904Recruiting
- Frontier Clinical Research - Kingwood /ID# 231914Recruiting
- Puerto Rico Health Institute /ID# 249162Recruiting
- GCM Medical Group PSC /ID# 249643Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Experimental
Experimental
Placebo Comparator
PK Cohort: Ubrogepant Dose A
PK Cohort: Ubrogepant Dose B
Main Study: Children Ubrogepant Low Dose
Main Study: Children Ubrogepant High Dose
Main Study: Children Ubrogepant Placebo
Main Study: Adolescents Ubrogepant Low Dose
Main Study: Adolescents Ubrogepant High Dose
Main Study: Adolescents Ubrogepant Placebo
Participants aged 6 to 11 will receive oral tablets of ubrogepant for PK analysis to determine appropriate dose for main study.
Participants aged 6 to 11 will receive oral tablets of ubrogepant for PK analysis to determine appropriate dose for main study.
Participants aged 6 to 11 (after dose selection) will receive oral tablets of low dose ubrogepant for qualifying migraine attack. Participants have the option to take a second dose of ubrogepant or rescue medication, 2 to 24 hours after initial dose for headache of moderate/severe intensity.
Participants aged 6 to 11 (after dose selection) will receive oral tablets of high dose ubrogepant Dose B for qualifying migraine attack. Participants have the option to take a second dose of ubrogepant or rescue medication, 2 to 24 hours after initial dose for headache of moderate/severe intensity.
Participants aged 6 to 11 (after dose selection) will receive oral tablets of placebo-matching ubrogepant for qualifying migraine attack. Participants have the option to take a second dose of placebo-matching ubrogepant or rescue medication, 2 to 24 hours after initial dose for headache of moderate/severe intensity.
Participants aged 12 to 17 will receive oral tablets of ubrogepant low dose for qualifying migraine attack. Participants have the option to take a second dose of ubrogepant or rescue medication, 2 to 24 hours after initial dose for headache of moderate/severe intensity.
Participants aged 12 to 17 will receive oral tablets of ubrogepant high dose or qualifying migraine attack. Participants have the option to take a second dose of ubrogepant or rescue medication, 2 to 24 hours after initial dose for headache of moderate/severe intensity.
Participants aged 12 to 17 will receive oral tablets of placebo-matching ubrogepant for qualifying migraine attack. Participants have the option to take a second dose of placebo-matching ubrogepant or rescue medication, 2 to 24 hours after initial dose for headache of moderate/severe intensity.