Ubrogepant for Pediatric Migraine
(Ubro Peds Trial)
Recruiting in Palo Alto (17 mi)
+130 other locations
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Allergan
Must not be taking: Opioids, Barbiturates, Triptans, others
Disqualifiers: Chronic migraine, Psychiatric conditions, others
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?This trial will test if ubrogepant is safe and effective for young people with migraines. Ubrogepant is a medication taken by mouth to treat migraine headaches. It works by blocking a protein in the brain that causes migraine pain. The study focuses on children and adolescents who suffer from migraines.
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications. However, if you are taking any medication that is on the list of prohibited medications, you may need to discontinue or switch to an alternative medication.
What data supports the effectiveness of the drug Ubrogepant for treating pediatric migraine?
Research shows that Ubrogepant is effective for treating acute migraine in adults, as it helps reduce pain and other bothersome symptoms during a migraine attack. This suggests it might also be effective for pediatric migraine, although specific studies in children are needed.
12345Is Ubrogepant safe for treating migraines?
Ubrogepant has been shown to be generally safe for treating migraines in adults, with studies confirming its safety over a 52-week period. However, its long-term safety in a large population and in combination with other treatments still needs more research.
26789How is the drug Ubrogepant unique for treating pediatric migraine?
Ubrogepant is unique because it is an oral medication that works by blocking the calcitonin gene-related peptide (CGRP) receptor, which is involved in migraine attacks. This mechanism is different from traditional migraine treatments that often focus on pain relief after the headache starts.
134910Eligibility Criteria
This trial is for children and adolescents aged 6-17 with a history of migraines, experiencing 1-14 attacks per month. They must have tried at least one oral migraine medication and their migraines should last between 3-72 hours if untreated. Exclusions include drug abuse, certain gastrointestinal conditions, specific types of migraines like hemiplegic or retinal, significant neurological disorders other than migraine, frequent hospital treatments for migraines, suicide risk, hypersensitivity to CGRP receptor antagonists or any study components.Inclusion Criteria
I have tried at least one over-the-counter oral medication for my child's migraines.
My child has had migraines for at least 6 months.
My child experiences 1-14 migraine attacks monthly.
+1 more
Exclusion Criteria
I can swallow pills or can learn to do so.
I have had 1 to 14 moderate to severe migraines each month for the last 2 months.
You have expressed thoughts of hurting yourself or others in the past 6 months, or have attempted to hurt yourself in the past 6 months.
+10 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive oral tablets of ubrogepant or placebo for qualifying migraine attacks, with an option for a second dose or rescue medication
Up to 6 months
Regular visits at a hospital or clinic
Follow-up
Participants are monitored for safety and effectiveness after treatment, including medical assessments, blood tests, and questionnaires
4 weeks
Participant Groups
The trial tests the safety and effectiveness of Ubrogepant—an approved adult migraine treatment—in young patients during acute migraine episodes. Participants will be split into two age groups (6-11 and 12-17) and randomly assigned to receive either a low or high dose of Ubrogepant or a placebo in a double-blind manner. There's a chance they'll get the placebo instead of the actual drug.
8Treatment groups
Experimental Treatment
Placebo Group
Group I: PK Cohort: Ubrogepant Dose BExperimental Treatment1 Intervention
Participants aged 6 to 11 will receive oral tablets of ubrogepant for PK analysis to determine appropriate dose for main study.
Group II: PK Cohort: Ubrogepant Dose AExperimental Treatment1 Intervention
Participants aged 6 to 11 will receive oral tablets of ubrogepant for PK analysis to determine appropriate dose for main study.
Group III: Main Study: Children Ubrogepant Low DoseExperimental Treatment1 Intervention
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, starting 2 hours after initial dose for headache of moderate/severe intensity.
Group IV: Main Study: Children Ubrogepant High DoseExperimental Treatment1 Intervention
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, starting 2 hours after initial dose for headache of moderate/severe intensity.
Group V: Main Study: Adolescents Ubrogepant Low DoseExperimental Treatment1 Intervention
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, starting 2 hours after initial dose for headache of moderate/severe intensity.
Group VI: Main Study: Adolescents Ubrogepant High DoseExperimental Treatment1 Intervention
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, starting 2 hours after initial dose for headache of moderate/severe intensity.
Group VII: Main Study: Children Ubrogepant PlaceboPlacebo Group1 Intervention
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, starting 2 hours after initial dose for headache of moderate/severe intensity.
Group VIII: Main Study: Adolescents Ubrogepant PlaceboPlacebo Group1 Intervention
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, starting 2 hours after initial dose for headache of moderate/severe intensity.
Ubrogepant is already approved in United States for the following indications:
🇺🇸 Approved in United States as Ubrogepant for:
- Acute treatment of migraine in adults
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
DM Clinical Research /ID# 229826Houston, TX
Tribe Clinical Research LLC /ID# 230422Greenville, SC
Family Psychiatry of The Woodlands /ID# 230163The Woodlands, TX
Meridian Clinical Research LLC /ID# 228992Savannah, GA
More Trial Locations
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Who Is Running the Clinical Trial?
AllerganLead Sponsor
AbbVieLead Sponsor
References
Effect of Ubrogepant vs Placebo on Pain and the Most Bothersome Associated Symptom in the Acute Treatment of Migraine: The ACHIEVE II Randomized Clinical Trial. [2021]Ubrogepant is an oral calcitonin gene-related peptide receptor antagonist under investigation for acute treatment of migraine.
Evaluating Ubrogepant-related adverse events using the FDA adverse event reporting system. [2023]Migraine has a high prevalence in the population and accounts for 12% of primary headaches. Ubrogepant is used for the treatment of acute migraine, and although some clinical trials have demonstrated the safety of Ubrogepant, its long-term safety in a large sample of the population remains to be investigated.
Safety and Efficacy of Ubrogepant for the Acute Treatment of Episodic Migraine: A Meta-Analysis of Randomized Clinical Trials. [2021]Ubrogepant is a small molecular calcitonin gene-related peptide receptor antagonist that is used for the acute treatment of migraine.
Ubrogepant for the treatment of migraine attacks during the prodrome: a phase 3, multicentre, randomised, double-blind, placebo-controlled, crossover trial in the USA. [2023]Ubrogepant is a calcitonin gene-related peptide (CGRP) receptor antagonist that is approved for acute treatment of migraine. The prodrome is the earliest phase of a migraine attack and is characterised by non-aura symptoms that precede headache onset. The aim of this trial was to evaluate the efficacy, safety, and tolerability of ubrogepant 100 mg compared with placebo for the acute treatment of migraine when administered during the prodrome.
Ubrogepant Is Safe and Efficacious in Participants Taking Concomitant Preventive Medication for Migraine: A Pooled Analysis of Phase 3 Trials. [2022]Ubrogepant is a calcitonin gene-related peptide receptor antagonist indicated for acute treatment of migraine that can be used to treat breakthrough attacks in individuals taking preventive treatment for migraine. We evaluated the impact of preventive medication use on the efficacy and safety of ubrogepant for the acute treatment of migraine.
Ubrogepant: An Oral Calcitonin Gene-Related Peptide (CGRP) Receptor Antagonist for Abortive Migraine Treatment. [2022]To review the pharmacology, efficacy, and safety of ubrogepant as an abortive migraine treatment.
Long-Term Safety Evaluation of Ubrogepant for the Acute Treatment of Migraine: Phase 3, Randomized, 52-Week Extension Trial. [2021]To evaluate the long-term safety and tolerability of ubrogepant for the acute treatment of migraine.
Ubrogepant in the Acute Management of Migraine: A Narrative Review. [2021]Ubrogepant is a small-molecule calcitonin gene-related peptide (CGRP) receptor antagonist that received Food and Drug Administration (FDA) approval for the acute treatment of migraine with and without aura in adults. The ACHIEVE I and ACHIEVE II Phase III clinical trials showed that ubrogepant was superior to placebo for pain freedom and freedom of the most bothersome migraine-associated symptom at 2 hours after medication intake. The 52-week open label extension of the Phase III trials demonstrated safety of ubrogepant. A real-world study conducted at a tertiary headache center also confirmed the efficacy and safety of ubrogepant. Adverse event rates were higher in the real-world population. Studies are needed to evaluate its long-term efficacy and safety, especially in the setting of co-administration with other CGRP modulating therapies such as the CGRP monoclonal antibodies.
Ubrogepant for the Acute Treatment of Migraine: Pooled Efficacy, Safety, and Tolerability From the ACHIEVE I and ACHIEVE II Phase 3 Randomized Trials. [2023]Ubrogepant is an oral, small-molecule calcitonin gene-related peptide receptor antagonist approved for the acute treatment of migraine. The efficacy and safety of ubrogepant were demonstrated in two pivotal phase 3, single-attack, randomized, placebo-controlled trials (ACHIEVE I and ACHIEVE II).
Ubrogepant: First Approval. [2020]Ubrogepant (Ubrelvy™) is an orally administered, small molecule, highly-selective, calcitonin gene-related peptide (CGRP) antagonist that was developed by Allergan under license to Merck & Co. as an acute treatment for migraine. In December 2019, ubrogepant received its first global approval in the USA for the acute treatment of migraine (± aura) in adults. This article summarizes the milestones in the development of ubrogepant leading to its first global approval for the acute treatment of migraine (± aura) in adults.