Phase 3
Completed N=1,686
Efficacy, Safety, and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine
Source: ClinicalTrials.gov NCT02867709 ↗Enrolled (actual)
1,686
Serious AEs
0.1%
Results posted
Jan 2019
Primary outcomePrimary: Percentage of Participants With Pain Freedom at 2 Hours After Initial Dose — 14.3; 20.7; 21.8 percentage of participants — p=0.0285
◆ Published Evidence
Established
36citations · ~7 / year
Safety and efficacy of ubrogepant in participants with major cardiovascular risk factors in two single-attack phase 3 randomized trials: ACHIEVE I and II.
Summary
This study will evaluate the efficacy, safety, and tolerability of 2 doses of ubrogepant (25 and 50 mg) compared to placebo for the acute treatment of a single migraine attack.
Linked Publications (5)
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Safety and efficacy of ubrogepant in participants with major cardiovascular risk factors in two single-attack phase 3 randomized trials: ACHIEVE I and II.
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Functionality, satisfaction, and global impression of change with ubrogepant for the acute treatment of migraine in triptan insufficient responders: a post hoc analysis of the ACHIEVE I and ACHIEVE II randomized trials.
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Ubrogepant Is Safe and Efficacious in Participants Taking Concomitant Preventive Medication for Migraine: A Pooled Analysis of Phase 3 Trials.
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Rimegepant, Ubrogepant, and Lasmiditan in the Acute Treatment of Migraine Examining the Benefit-Risk Profile Using Number Needed to Treat/Harm.
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Efficacy of ubrogepant and atogepant in males and females with migraine: A secondary analysis of randomized clinical trials.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Pain Freedom at 2 Hours After Initial Dose |
14.3; 20.7; 21.8 | 0.0285 sig |
| PRIMARY Percentage of Participants With Absence of the Most Bothersome Migraine-Associated Symptom Identified at Baseline at 2-Hours After Initial Dose |
27.4; 34.1; 38.9 | 0.0711 |
| SECONDARY Percentage of Participants With Pain Relief at 2 Hours After the Initial Dose |
48.2; 60.5; 62.7 | 0.0711 |
| SECONDARY Percentage of Participants With Sustained Pain Relief From 2 to 24 Hours After Initial Dose |
21.0; 32.5; 36.7 | 0.0711 |
| SECONDARY Percentage of Participants With Sustained Pain Freedom From 2 to 24 Hours After Initial Dose |
8.2; 12.7; 14.4 | 0.0711 |
| SECONDARY Percentage of Participants With the Absence of Photophobia at 2 Hours After the Initial Dose |
35.5; 39.3; 43.8 | 0.1833 |
| SECONDARY Percentage of Participants With the Absence of Phonophobia at 2 Hours After the Initial Dose |
46.3; 53.6; 54.1 | 0.1066 |
| SECONDARY Percentage of Participants With Absence of Nausea at 2 Hours After the Initial Dose |
70.0; 70.6; 71.3 | 0.9522 |
Eligibility Criteria
Inclusion Criteria
- At least a 1-year history of migraine with or without aura consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd edition, beta version
- Migraine onset before age 50
- History of migraines typically lasting 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 pain in each of the previous 3 months.
Exclusion Criteria
- Difficulty distinguishing migraine headache from tension-type other headaches
- Has taken medication for acute treatment of headache (including acetaminophen, nonsteroidal anti-inflammatory drugs [NSAIDs], triptans, ergotamine, opioids, or combination analgesics) on 10 or more days per month in the previous 3 months
- Has a history of migraine aura with diplopia or impairment of level of consciousness, hemiplegic migraine, or retinal migraine
- Has a current diagnosis of new persistent daily headache, trigeminal autonomic cephalgia (eg, cluster headache), or painful cranial neuropathy
- Required hospital treatment of a migraine attack 3 or more times in the previous 6 months
- Has a chronic non-headache pain condition requiring daily pain medication
- Has a history of malignancy in the prior 5 years, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer
- Has a history of any prior gastrointestinal conditions (eg, diarrhoea syndromes, inflammatory bowel disease) that may affect the absorption or metabolism of investigational product; participants with prior gastric bariatric interventions which have been reversed are not excluded
- Has a history of hepatitis within previous 6 months.
Data sourced from ClinicalTrials.gov (NCT02867709) 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.