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

Phase 3

Completed

Conditions: Migraine, With or Without Aura

Interventions: Drug: Ubrogepant
Drug: Placebo-matching Ubrogepant

Registration Number: NCT02828020

Lead Sponsor: Allergan

Brief Summary: This study will evaluate the efficacy, safety, and tolerability of 2 doses of ubrogepant (50 and 100 mg) compared to placebo for the acute treatment of a single migraine attack.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1672

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 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, diarrhea 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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ubrogepant 100 mg	Ubrogepant	2 Ubrogepant 50 mg tablets, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, 2 placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.
Placebo	Placebo-matching Ubrogepant	2 placebo-matching ubrogepant 50 mg tablets, orally for treatment of a qualifying migraine attack. Participants had the option to take 2-placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.
Ubrogepant 50 mg	Ubrogepant	1 ubrogepant 50 mg tablet and 1 placebo-matching ubrogepant 50 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, 2 placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.
Ubrogepant 100 mg	Placebo-matching Ubrogepant	2 Ubrogepant 50 mg tablets, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, 2 placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.
Ubrogepant 50 mg	Placebo-matching Ubrogepant	1 ubrogepant 50 mg tablet and 1 placebo-matching ubrogepant 50 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, 2 placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Absence of the Most Bothersome Migraine-Associated Symptom Identified at Baseline at 2-Hours After Initial Dose	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.
Percentage of Participants With Pain Freedom at 2 Hours After Initial Dose	Baseline (Predose) to 2 hours after initial dose	Pain freedom was defined as a reduction in headache severity from moderate/severe at baseline to no pain at 2 hours after the initial dose. Participants were provided with an 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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With the Absence of Photophobia at 2 Hours After the Initial Dose	2 hours after initial dose	Photophobia was defined as sensitivity to light, a migraine-associated symptom. Participants were provided with an eDiary to record absence or presence photophobia. Number analyzed is the number of participants with non-missing postdose photophobia assessment at or before 2 hours after initial dose.
Percentage of Participants With the Absence of Phonophobia at 2 Hours After the Initial Dose	2 hours after initial dose	Phonophobia was defined as sensitivity to sound, a migraine-associated symptom. Participants were provided with an eDiary to record absence or presence of phonophobia. Number analyzed is the number of participants with non-missing postdose phonophobia assessment at or before 2 hours after initial dose.
Percentage of Participants With Pain Relief at 2 Hours After the Initial Dose	Baseline (Predose) to 2 hours after 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.
Percentage of Participants With Sustained Pain Relief From 2 to 24 Hours After Initial Dose	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 determinable sustained pain relief from 2 to 24 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	Sustained pain freedom was defined as a pain freedom at 2 hours with no administration of either rescue medication or the second dose of study drug, and with no occurrence thereafter of a mild/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 determinable sustained pain freedom from 2 to 24 hours after initial dose.
Percentage of Participants With Absence of Nausea at 2 Hours After the Initial Dose	2 hours after initial dose	Nausea was a migraine-associated symptom. Participants were provided with an eDiary to record absence or presence of nausea. Number analyzed is the number of participants with non-missing postdose nausea assessment at or before 2 hours after initial dose.

Trial Locations

Locations (87): Clinical Research Advantage, Inc./Desert Clinical Research, LLC.
🇺🇸
Mesa, Arizona, United States
Xenoscience, Inc.
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Phoenix, Arizona, United States
Clinical Research Advantage, Inc./Orange Grove Family Practice
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Tucson, Arizona, United States
Principals Research Group, Inc.
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Hot Springs, Arkansas, United States
KLR Business Group, Inc. dba Arkansas Clinical Research
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Little Rock, Arkansas, United States
The Research Center of Southern California, LLC
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Carlsbad, California, United States
Med Center
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Carmichael, California, United States
T. Joseph Raoof MD, Inc./Encino Research Center
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Encino, California, United States
Neurology Center of North Orange County
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Fullerton, California, United States
Behavioral Research Specialists, LLC
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Glendale, California, United States
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Clinical Research Advantage, Inc./Desert Clinical Research, LLC.
🇺🇸Mesa, Arizona, United States