Atogepant for Pediatric Migraine
(Kaleidoscope Trial)

Recruiting in Palo Alto (17 mi)

+116 other locations

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: AbbVie

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?A migraine is a 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. A number of treatments are available for adults with migraine but there are limited approved treatments available for participants less than 18 years of age. The main goal of the study is to evaluate the long-term safety and tolerability of atogepant in pediatric participants between the ages of 6 and 17 with migraine. Atogepant is a medicine currently approved to treat adults with migraine (0 to 14 migraine days per month) and is being studied in pediatric participants between the ages of 6 and 17 with a history of migraine. This is a Phase 3, open-label study of atogepant in participants with a history of migraine. Participants must have completed participation in another study of atogepant (lead-in study). Participants must have 4 to 14 migraine days and less than 15 headache days for episodic migraine, and \>= 15 headache days and \>= 8 migraine days for chronic migraine in the 4-week screening electronic diary (eDiary; similar to a smart phone). Around 650 participants will be enrolled in the study at approximately 100 sites worldwide. Atogepant is a tablet taken once a day by mouth. Participants between the ages of 12 and 17 will receive high dose atogepant for 52 Weeks. Participants between the ages of 6 and 11 will receive an atogepant dose determined in the lead-in study for 52 Weeks. There may be a bigger responsibility for participants in this study. Participants will attend regular visits during the study at a hospital or clinic. The effects of treatment will be checked by medical assessments, blood tests, checking for side effects, and completing questionnaires.

Eligibility Criteria

This trial is for kids aged 6-17 with episodic migraines, weighing between 44 and 298 lbs. They must have had migraines for at least six months and experience them on 4 to14 days per month. Participants should have finished a prior study or its screening phase but not met the migraine day count required there.

Inclusion Criteria

I have had migraines for at least 6 months.

I am between 6 and 17 years old and have a history of migraine attacks.

Participant must have completed specific study requirements or screening criteria

+1 more

Exclusion Criteria

I have been diagnosed with a specific type of migraine.

I have been diagnosed with chronic migraine or a specific headache disorder.

I have a serious health condition affecting my blood, hormones, lungs, kidneys, liver, stomach, heart, or nervous system.

Participant Groups

The trial tests Atogepant's long-term safety in children with migraines. It's an open-label Phase 3 study where participants take Atogepant daily for a year. The dosage varies by age: high dose for ages 12-17, and a specific dose determined earlier for ages 6-11.

2Treatment groups

Experimental Treatment

Group I: Atogepant Dose B (6-11 yrs)Experimental Treatment1 Intervention

Participants aged 6-11 will receive the highest dose of oral tablets of atogepant tested in the lead-in study M21-201.

Group II: Atogepant Dose A (12-17 yrs)Experimental Treatment1 Intervention

Participant aged 12-17 will receive oral tablets of atogepant Dose A once a day for up to 52 weeks.

Atogepant is already approved in United States for the following indications:

🇺🇸 Approved in United States as Qulipta for: