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Last Updated: March 28, 2024

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CLINICAL TRIALS PROFILE FOR UBRELVY


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All Clinical Trials for UBRELVY

Trial ID Title Status Sponsor Phase Start Date Summary
NCT04818515 ↗ Study To Assess Adverse Events and Drug to Drug Interaction of Oral Tablet Atogepant and Ubrogepant in Adult Participants With a History of Migraine Completed Allergan Phase 1 2021-03-17 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. This study will assess the drug to drug interaction between atogepant and ubrogepant and assess the safety of atogepant and ubrogepant, when given alone or in combination, in adult participants with migraine. Atogepant is an investigational (unapproved) drug for the preventative treatment of migraine. Ubrogepant is a drug approved for the acute treatment of migraine. Adult participants with a history of migraine will be enrolled. Approximately, 30 participants will be enrolled in the study in multiple sites in the United States. Participants will receive oral tablets of ubrogepant, followed be oral tablets of atogepant, followed by administration of oral tablets of atogepant and ubrogepant in combination. The study duration will be 30 days with a 7 day follow period. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, telephone assessments, blood tests, checking for side effects, and clinician-rated assessments.
NCT05125302 ↗ 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) Not yet recruiting Allergan Phase 3 2021-11-09 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, 2 to 24 hours after the initial dose, for headache of moderate/severe intensity. Around 1059 participants will be enrolled in the study in approximately 120 sites in the United States. The study duration will be up to 6 months. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
NCT05127954 ↗ Long-term Extension Study to Assess Safety and Tolerability of Oral Ubrogepant Tablets for the Acute Treatment of Migraine in Children and Adolescents (Ages 6-17) Not yet recruiting Allergan Phase 3 2021-11-12 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 long term safety and tolerability of ubrogepant 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. Participants who completed the lead-in Study 3110-305-002, as well as those who were placebo responders and screen failed, will be eligible to enroll into this study. Around 1200 participants will be enrolled in the study at approximately 103 sites in the United States. Participants may receive ubrogepant oral tables to treat up to 8 migraine attacks of any intensity per month. There will be an option to take a second dose of study intervention (identical to initial dose), or rescue medication, starting 2 hours after the initial dose. The study duration will be up to 54 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The safety and tolerability of the treatment will be checked by medical assessments, blood tests, checking for adverse events and completing questionnaires.
NCT05214001 ↗ Evaluation of the Efficacy of Almotriptan and Ubrogepant for the Acute Treatment of Migraine Not yet recruiting Messoud Ashina, MD Phase 4 2022-02-01 In a real-world population of adults with migraine, the investigators would like to investigate whether 12.5 mg almotriptan is non-inferior to 50 mg ubrogepant in terms of pain freedom at 2 hours after drug intake.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for UBRELVY

Condition Name

Condition Name for UBRELVY
Intervention Trials
Migraine 3
Episodic Migraine 1
Headache, Migraine 1
Healthy Volunteers 1
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Condition MeSH

Condition MeSH for UBRELVY
Intervention Trials
Migraine Disorders 6
Headache 1
Migraine without Aura 1
Migraine with Aura 1
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Clinical Trial Locations for UBRELVY

Trials by Country

Trials by Country for UBRELVY
Location Trials
United States 87
Denmark 1
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Trials by US State

Trials by US State for UBRELVY
Location Trials
Missouri 4
Florida 4
Texas 3
Ohio 3
Pennsylvania 3
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Clinical Trial Progress for UBRELVY

Clinical Trial Phase

Clinical Trial Phase for UBRELVY
Clinical Trial Phase Trials
Phase 4 3
Phase 3 2
Phase 1 2
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Clinical Trial Status

Clinical Trial Status for UBRELVY
Clinical Trial Phase Trials
Not yet recruiting 6
Completed 1
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Clinical Trial Sponsors for UBRELVY

Sponsor Name

Sponsor Name for UBRELVY
Sponsor Trials
Allergan 4
AbbVie 2
Messoud Ashina, MD 1
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Sponsor Type

Sponsor Type for UBRELVY
Sponsor Trials
Industry 6
Other 2
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