Study to Evaluate Oral Ubrogepant in the Acute Treatment of Migraine During the Prodrome in Adult Participants
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: Ubrogepant 100 mg; Placebo
Intervention description: For each qualifying prodrome event, 2 compressed tablets containing 50 mg of ubrogepant will be taken orally when the participant is confident that a headache will follow within 1-6 hours; For each qualifying prodrome event, 2 compressed tablets containing placebo will be taken orally when the participant is confident that a headache will follow within 1-6 hours
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 518.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Migraine

Summary:

      Study to Evaluate the Efficacy, Safety, and Tolerability of Oral Ubrogepant in the Acute
      Treatment of Migraine When Administered During the Prodrome
    

Eligibility criteria:

        Inclusion Criteria:

          -  At least a 1-year history of migraine with or without aura consistent with a diagnosis
             according to the ICHD-3 (International Classification of Headache Disorders 3rd
             edition)

          -  Migraine onset before age 50 years

          -  By history, the participant's migraines typically last between 4 and 72 hours if
             untreated or treated unsuccessfully and migraine episodes are separated by at least 48
             hours of headache pain freedom

          -  History of 2 to 8 migraine attacks per month with moderate to severe headache in each
             of the 3 months prior to the Screening Visit

        Exclusion Criteria:

          -  Difficulty distinguishing migraine headache from tension-type or other headaches

          -  Participants who overuse medication for migraine defined as use of opioids or
             barbiturates > 2 days/month, triptans or ergots ≥ 10 days/month, or simple analgesics
             (eg, aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen) ≥ 15
             days/month in the 3 months prior to Visit 1 per investigator's judgment

          -  Has a history of migraine aura with diplopia or impairment of level of consciousness,
             hemiplegic migraine, or retinal migraine as defined by ICHD-3

          -  A current diagnosis of chronic migraine as defined by ICHD-3 or a history of 15 or
             more headache days per month on average in the 6 months prior to Visit 1 in the
             investigator's judgment. A headache day is defined as a day in which there was any
             occurrence of a headache of a minimum duration of 2 hours or a headache of any
             duration for which acute medication was taken

          -  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 hospital treatment of a migraine attack 3 or more times in the 6 months prior
             to Visit 1

          -  History of malignancy in the 5 years prior to Visit 1, except for adequately treated
             basal cell or squamous cell skin cancer, or in situ cervical cancer

          -  History of any prior gastrointestinal conditions (eg, diarrhea syndromes, inflammatory
             bowel disease) that, per investigator judgment, may affect the absorption or
             metabolism of the study intervention; participants with prior gastric bariatric
             interventions (eg, Lap Band) which have been reversed are not excluded