Efficacy, Safety, and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine

Allergan1,686 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

1,686

Conditions

Migraine, With or Without Aura

Interventions

UbrogepantDRUG

Ubrogepant tablet(s) orally for the treatment of a qualifying migraine attack.

Placebo-matching UbrogepantDRUG

Placebo-matching ubrogepant tablet(s) orally for the treatment of a qualifying migraine attack.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (109)

Outcomes

Primary Outcomes

Percentage of Participants With Pain Freedom at 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.

Time frame: Baseline (Predose) to 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

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.

Time frame: Baseline (Predose) to 2 hours after initial dose

Secondary Outcomes

Percentage of Participants With Pain Relief at 2 Hours After the Initial Dose

Pain relief was defined as a reduction of a moderate/severe migraine headache to a mild headache or to no headache. Participants were provided with an eDiary to rate headache severity on a scale from no pain to severe pain. Number analyzed is the number of participants with non-missing pain severity assessment at or before 2 hours after initial dose.

Time frame: Baseline (Predose) to 2 hours after initial dose

Percentage of Participants With Sustained Pain Relief From 2 to 24 Hours After Initial Dose

Sustained pain relief was defined as a pain relief at 2 hours with no administration of either rescue medication or the second dose of study drug, and with no occurrence thereafter of a moderate/severe headache up to 24 hours after dosing with study drug. Participants were provided with an eDiary to rate headache severity on a scale from no pain to severe pain. Determinable cases: participants for whom sustained pain relief from 2 to 24 hours status can be determined based on the observed headache severity at scheduled time points, use of rescue medication or optional second dose between 2 and 24 hours, and the answer to the headache recurrence question at 24 hours. Number analyzed is the number of participants with assessment of determinable sustained pain relief from 2 to 24 hours after initial dose.

Data from ClinicalTrials.gov

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