Ubrogepant in the Acute Treatment of Migraine
Research type
Research Study
Full title
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Multiple-Attack, Crossover Study to Evaluate the Efficacy, Safety, and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine.
IRAS ID
227936
Contact name
Amrit Rai
Contact email
Sponsor organisation
Allergan Ltd
Eudract number
2016-003119-36
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
The purpose of this study is to investigate if ubrogepant is safe and effective in the treatment of migraine, with or without aura. Migraine is typically characterised by attacks of throbbing, unilateral (one sided) headache of moderate or severe pain intensity, associated with nausea, vomiting, and/or sensitivity to light (photophobia) and sound (phonophobia). Aura are symptoms related to migraines and can include visual changes such as flashes of light, blind spots, or tingling in your hand or face.
Participants will be randomised to receive either 50mg Ubrogepant or 100mg Ubrogepant for treatment of 4 migraine attacks and placebo for 1 migraine attack. In total, they will be asked to treat 5 migraine attacks and will be randomly assigned to 1 of 10 treatment sequences.
Participants will be asked to take 2 tablets to treat each qualifying migraine. After treating each migraine with study medication, participants will be allowed to take an optional second dose of study medication or take rescue medication. When taking the optional second dose they will receive either the same treatment as the initial dose or placebo. If they received placebo for the initial dose they will also receive placebo for the optional second dose. They may also choose to take rescue medication, which is medication they would usually take to treat a migraine such as paracetamol and ibuprofen.
Study will last approximately 7 months. There will be at least 5 and up to 10 study site visits. After the first visit (Screening Visit), the second visit (randomisation) will take place within 14 days. If eligible, participants will have up to 24 weeks to treat 5 migraine headaches.
The first migraine must be treated within 8 weeks. After the first migraine is treated, participants will be asked to return to the study site in about 4 days. They will visit the study site every 4 weeks post randomisation until all 5 qualifying migraine attacks have been treated. Final site visit will take place 4 days after the fifth migraine headache is treated. A safety follow up visit will take place 4 weeks later.
Approximately 1752 patients will be randomised globally (UK, EU, Canada, Russian Federation & USA)
REC name
London - Westminster Research Ethics Committee
REC reference
17/LO/1059
Date of REC Opinion
10 Jul 2017
REC opinion
Favourable Opinion