Phase 3
Completed N=518
Study to Evaluate Oral Ubrogepant in the Acute Treatment of Migraine During the Prodrome in Adult Participants
Source: ClinicalTrials.gov NCT04492020 ↗Enrolled (actual)
518
Serious AEs
0.1%
Results posted
May 2023
Primary outcomePrimary: Percentage of Participants Reporting Absence of Headache of Moderate/Severe Intensity Within 24 Hours Post-dose — 121; 190 Participants — p=<.0001
◆ Published Evidence
Established
87citations · ~29 / year
Ubrogepant for the treatment of migraine attacks during the prodrome: a phase 3, multicentre, randomised, double-blind, placebo-controlled, crossover trial in the USA.
Summary
Study to Evaluate the Efficacy, Safety, and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine When Administered During the Prodrome
Linked Publications (4)
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Ubrogepant for the treatment of migraine attacks during the prodrome: a phase 3, multicentre, randomised, double-blind, placebo-controlled, crossover trial in the USA.
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Characterizing Prodrome (Premonitory Phase) in Migraine: Results From the PRODROME Trial Screening Period.
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Efficacy of ubrogepant and atogepant in males and females with migraine: A secondary analysis of randomized clinical trials.
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Effect of Ubrogepant on Patient-Reported Outcomes When Administered During the Migraine Prodrome: Results From the Randomized PRODROME Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Reporting Absence of Headache of Moderate/Severe Intensity Within 24 Hours Post-dose |
121; 190 | <.0001 sig |
| SECONDARY Percentage of Participants Reporting Absence of Headache of Moderate or Severe Intensity Within 48 Hours Post-dose |
100; 159 | <.0001 sig |
| SECONDARY Percentage of Participants Reporting Improvement in the Ability to Function Normally Over 24 Hours Post-dose |
96; 107; 336; 311; 110; 156 | <.0001 sig |
| SECONDARY Percentage of Participants Reporting Absence of Headache of Any Intensity Within 24 Hours Post-dose |
61; 103 | <.0001 sig |
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
Data sourced from ClinicalTrials.gov (NCT04492020) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.