Atogepant for Prophylaxis of Migraine in Participants Who Failed Previous Oral Prophylactic Treatments. (ELEVATE)

Allergan

Status and phase: Completed; Phase 3

Conditions: Episodic Migraine

Treatments: Drug: Placebo; Drug: Atogepant 60 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT04740827

2019-003448-58 (EudraCT Number)

3101-304-002

Details and patient eligibility

About

This study will assess the safety, tolerability, and efficacy of Atogepant 60 mg compared with placebo in participants with episodic migraine and who have previously failed 2 to 4 classes of oral prophylactic treatments.

Enrollment: 315 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• At least a 1-year history of migraine with or without aura consistent with a diagnosis according to the ICHD-3, 2018.
• Age of the participant at the time of migraine onset < 50 years -History of 4 to 14 migraine days per month on average in the 3 months prior to Visit 1 in the investigator's judgment
• Female participants willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up period. Male participants willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up period.
• 4 to 14 migraine days in the 28-day baseline period per eDiary
• Failed oral migraine prophylaxis medications from 2 to 4 medication classes

Exclusion criteria

• Any clinically significant hematologic, endocrine, pulmonary, hepatic, gastrointestinal, or neurologic disease
• Participant has any other concurrent pain condition that, in the opinion of the investigator, may significantly impact the current headache disorder
• In the opinion of the investigator, confounding psychiatric conditions, dementia, epilepsy, or significant neurological disorders other than migraine
• Has ≥ 15 headache days per month on average across the 3 months prior to Visit 1 in the investigator's judgment
• Has ≥ 15 headache days in the 28-day baseline period per eDiary
• Clinically significant cardiovascular or cerebrovascular disease
• Has a history of migraine accompanied by diplopia or decreased level of consciousness or retinal migraine as defined by ICHD-3, 2018
• Has a current diagnosis of chronic migraine, new persistent daily headache, medication overuse headache, trigeminal autonomic cephalgia (eg, cluster headache), or painful cranial neuropathy as defined by ICHD-3, 2018

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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315 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants received atogepant-matching placebo tablets, orally, once daily (QD) for up to 12 weeks in a double-blind (DB) treatment period.

Treatment:

Drug: Placebo

Atogepant 60 mg

Active Comparator group

Description:

Participants received atogepant 60 mg, orally, QD for up to 12 weeks in a DB treatment period.

Treatment:

Drug: Atogepant 60 mg