RecruitingPhase 3interventionalRules rewrite

Phase 3: testing Atogepant for Chronic Migraine

Migraine is a disease that most often causes moderate to severe headache on one side of the head. A migraine attack is a headache that may be accompanied by throbbing, nausea, vomiting, sensitivity to light and sound, or other symptoms.

Official registry: https://clinicaltrials.gov/study/NCT06810505 · AbbVie · enrollment listed as 420

What this phase means

Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Atogepant, or Placebo for Atogepant. The registry lists allocation as randomized. Migraine is a disease that most often causes moderate to severe headache on one side of the head.

They plan to enroll about 420 people at 66 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

A Phase 3, Multicenter, 12-Week, Double Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Atogepant for the Preventive Treatment of Chronic Migraine in Pediatric Subjects 12 to 17 Years of Age

Interventions: Atogepant, Placebo for Atogepant

Primary outcome (registry wording): Number of Participants Experiencing Adverse Events (AEs)

Who it is for (from inclusion criteria)

Ages 12 Years to 17 Years
History of chronic migraine with or without aura consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition (ICHD-3) (2018) for at least 6 months as of Visit 1
During the last 28 days of the screening/baseline period, and as per eDiary:
Participant must have completed the eDiary for a minimum of 20 out of 28 days
Participant has \>= 15 headache days
Participant has \>= 8 migraine days

Who the registry excludes

Clinically significant hypertension per investigator's judgment
History of any clinically significant hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal, cardiovascular or neurologic disease

Public study contact (from the registry)

ABBVIE CALL CENTER

844-663-3742

abbvieclinicaltrials@abbvie.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

66 listed

Rehabilitation and Neurological Services /ID# 270782 — Huntsville, Alabama (recruiting)
Preferred Research Partners - Fayetteville /ID# 270419 — Fayetteville, Arkansas (completed)
Preferred Research Partners /ID# 270389 — Little Rock, Arkansas (recruiting)
Advanced Research Center /ID# 270257 — Anaheim, California (recruiting)
Neuro Pain Research Center /ID# 271048 — Fresno, California (recruiting)
Alliance for Research Alliance for Wellness /ID# 270398 — Long Beach, California (recruiting)
Excell Research /ID# 270258 — Oceanside, California (recruiting)
Lumos Clinical Research Center /ID# 270582 — San Jose, California (recruiting)
Sunwise Clinical Research /ID# 270431 — Walnut Creek, California (recruiting)
Northwest Florida Clinical Research Group, LLC /ID# 270833 — Gulf Breeze, Florida (recruiting)
Auzmer Research /ID# 271158 — Lakeland, Florida (completed)
My Preferred Research /ID# 270312 — Miami, Florida (recruiting)

+ 34 sites outside the US on the same record

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FAQ about this NCT record

Is NCT06810505 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06810505?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06810505?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary