A Phase 3, Multicenter, Randomized, Double-Blind, Placebo Controlled Single Attack Study to Evaluate the Efficacy, Safety, and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Allergan
- Enrollment
- 1,686
- Locations
- 105
- Primary Endpoint
- Percentage of Participants With Pain Freedom at 2 Hours After Initial Dose
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Ubrogepant 25 mg
1 ubrogepant 25 milligram (mg) tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.
Intervention: Ubrogepant (Drug)
Ubrogepant 25 mg
1 ubrogepant 25 milligram (mg) tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.
Intervention: Placebo-matching Ubrogepant (Drug)
Ubrogepant 50 mg
1 ubrogepant 50 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.
Intervention: Ubrogepant (Drug)
Ubrogepant 50 mg
1 ubrogepant 50 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.
Intervention: Placebo-matching Ubrogepant (Drug)
Placebo
1 placebo-matching ubrogepant tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.
Intervention: Placebo-matching Ubrogepant (Drug)
Outcomes
Primary Outcomes
Percentage of Participants With Pain Freedom at 2 Hours After Initial Dose
Time Frame: Baseline (Predose) to 2 hours after initial dose
Pain freedom was defined as a reduction in headache pain severity from moderate/severe at baseline to no pain at 2 hours after the initial dose of investigational product. Participants were provided with electronic diary (eDiary) to rate headache severity on a scale from no pain to severe pain. Number analyzed is the number of participants with non-missing postdose pain severity assessment at or before 2 hours after initial dose.
Percentage of Participants With Absence of the Most Bothersome Migraine-Associated Symptom Identified at Baseline at 2-Hours After Initial Dose
Time Frame: Baseline (Predose) to 2 hours after initial dose
The most bothersome migraine-associated symptom was the symptom (photophobia, phonophobia or nausea) present at pre-dose baseline identified by the participant to be 'most bothersome'. Participants were provided with an eDiary to record absence or presence of migraine-associated symptoms. Number analyzed is the number of participants with non-missing postdose most bothersome migraine-associated symptoms assessed.
Secondary Outcomes
- Percentage of Participants With Pain Relief at 2 Hours After the Initial Dose(Baseline (Predose) to 2 hours after initial dose)
- Percentage of Participants With Absence of Nausea at 2 Hours After the Initial Dose(2 hours after initial dose)
- Percentage of Participants With Sustained Pain Relief From 2 to 24 Hours After Initial Dose(2 to 24 hours after initial dose)
- Percentage of Participants With the Absence of Photophobia at 2 Hours After the Initial Dose(2 hours after initial dose)
- Percentage of Participants With Sustained Pain Freedom From 2 to 24 Hours After Initial Dose(2 to 24 hours after initial dose)
- Percentage of Participants With the Absence of Phonophobia at 2 Hours After the Initial Dose(2 hours after initial dose)