Status:
COMPLETED
Study to Evaluate Oral Ubrogepant in the Acute Treatment of Migraine During the Prodrome in Adult Participants
Lead Sponsor:
AbbVie
Conditions:
Migraine
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief 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
- 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
- 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
Key Trial Info
Start Date :
August 21 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 19 2022
Estimated Enrollment :
518 Patients enrolled
Trial Details
Trial ID
NCT04492020
Start Date
August 21 2020
End Date
April 19 2022
Last Update
May 31 2023
Active Locations (73)
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1
Achieve Clinical Research, LLC /ID# 237098
Birmingham, Alabama, United States, 35216
2
Barrow Neuro Institute /ID# 236775
Phoenix, Arizona, United States, 85013
3
Arkansas Clinical Research /ID# 238032
Little Rock, Arkansas, United States, 72205
4
California Headache and Balance Center /ID# 236247
Fresno, California, United States, 93720