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

Completed · Phase 3 · Has a placebo group

Conditions studied: Episodic Migraine

In brief

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.

Key facts

Study ID

NCT04740827

Run by

Allergan

People needed

315

Starts

2021-03-05

Expected to finish

2022-08-04

Last updated by the study team

2023-09-21

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Pharmacology Research Institute (PRI) - Encino (Wake) /ID# 226434 — Encino, California, United States
• Pharmacology Research Institute (PRI) - Los Alamitos (Wake) /ID# 226388 — Los Alamitos, California, United States
• Pharmacology Research Institute (PRI) - Los Alamitos (Wake) /ID# 226405 — Los Alamitos, California, United States
• Excell Research, Inc /ID# 228386 — Oceanside, California, United States
• Alpine Clinical Research Center /ID# 226201 — Boulder, Colorado, United States
• Sensible Healthcare /ID# 226197 — Ocoee, Florida, United States
• Meridien Research /ID# 226224 — St. Petersburg, Florida, United States
• Meridien Research /ID# 226302 — St. Petersburg, Florida, United States
• Velocity Clinical Research - Boise /ID# 226320 — Meridian, Idaho, United States
• Allied Physicians - Fort Wayne Neurological Center /ID# 226350 — Fort Wayne, Indiana, United States
• Deaconess Clinic - Gateway Health Center /ID# 226481 — Newburgh, Indiana, United States
• Pharmasite Research, Inc. /ID# 226445 — Baltimore, Maryland, United States
• StudyMetrix Research /ID# 226297 — City of Saint Peters, Missouri, United States
• Clinvest Research LLC /ID# 226273 — Springfield, Missouri, United States
• Methodist Physicians Clinic /ID# 226470 — Fremont, Nebraska, United States
• Amici Clinical Research - Raritan /ID# 226282 — Raritan, New Jersey, United States
• Albuquerque Clinical Trials, Inc /ID# 233445 — Albuquerque, New Mexico, United States
• CTI Clinical Trial and Consulting /ID# 226281 — Cincinnati, Ohio, United States
• FutureSearch Trials of Neurology /ID# 226423 — Austin, Texas, United States
• Austin Clinical Trial Partners /ID# 228387 — Austin, Texas, United States
• DiscoveResearch, Inc /ID# 226491 — Bryan, Texas, United States
• FutureSearch Trials of Dallas, LP /ID# 226493 — Dallas, Texas, United States
• LinQ Research, LLC /ID# 226227 — Pearland, Texas, United States
• Highland Clinical Research /ID# 226288 — Salt Lake City, Utah, United States
• Axiom Research /ID# 226379 — Colton, California, United States

Full record on ClinicalTrials.gov

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