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CGRP Antagonist
Oral Atogepant Tablets for Migraine (Kaleidoscope Trial)
Phase 3
Recruiting
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Weight is >= 20 kg (44 lbs) and < 135 kg (298 lbs).
History of episodic migraine with or without aura consistent with a diagnosis according to the International Classification of Headache Disorders (ICHD) -3 (2018) for at least 6 months.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (week 0) to 3 months
Awards & highlights
Kaleidoscope Trial Summary
This trial studies a medicine, atogepant, to see how safe and effective it is in children (ages 6-17) with episodic migraine headaches. Participants will be randomized to receive placebo, low or high doses of the medicine for 12 weeks.
Who is the study for?
This trial is for kids aged 6-17 with episodic migraines, weighing between 44 and 298 lbs. They must have had 4 to 14 migraine days in the past month but less than 15 headache days overall. It's not for those with certain other headaches or who've needed hospital treatment for migraines three times in six months.Check my eligibility
What is being tested?
The study tests low and high doses of atogepant, a migraine medication approved for adults, now being studied in children. Participants are randomly assigned to receive either a placebo or atogepant daily for twelve weeks, with some continuing up to a year.See study design
What are the potential side effects?
While specific side effects aren't listed here, participants will be monitored through medical assessments and blood tests. Side effects could include typical drug reactions such as nausea, fatigue, digestive issues or allergic responses.
Kaleidoscope Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My weight is between 44 lbs and 298 lbs.
Select...
I have been diagnosed with migraines, with or without aura, for at least 6 months.
Select...
I experience 4 to 14 migraine days and less than 15 headache days in a month.
Kaleidoscope Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (week 0) to 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (week 0) to 3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from Baseline in Mean Monthly Migraine Days
Secondary outcome measures
Change from Baseline in Mean Monthly Acute Medication Use Days
Change from Baseline in Mean Monthly Headache Days
Change from Baseline in the Pediatric Quality of Life Inventory (PedsQL) total score
+2 moreKaleidoscope Trial Design
8Treatment groups
Experimental Treatment
Group I: Open-Label PK Substudy: Atogepant Dose B (6-11 yrs)Experimental Treatment1 Intervention
Participants aged 6 to 11 will receive oral tablets of atogepant Dose B to determine appropriate dose for the 6-11 year old group in double-blind treatment period.
Group II: Open-Label PK Substudy: Atogepant Dose A (6-11 yrs)Experimental Treatment1 Intervention
Participants aged 6 to 11 will receive oral tablets of atogepant Dose A to determine appropriate dose for the 6-11 year old group in double-blind treatment period.
Group III: Double-Blind Treatment Period: Placebo (6-11 yrs)Experimental Treatment1 Intervention
Participants aged 6 to 11 will receive oral tablets of placebo-matching atogepant once a day for 12 weeks.
Group IV: Double-Blind Treatment Period: Placebo (12-17 yrs)Experimental Treatment1 Intervention
Participants aged 12 to 17 will receive oral tablets of placebo-matching atogepant once a day for 12 weeks.
Group V: Double-Blind Treatment Period: Low Dose Atogepant (6-11 yrs)Experimental Treatment1 Intervention
Participants aged 6-11 will receive oral tablets of low dose atogepant once a day for 12 weeks.
Group VI: Double-Blind Treatment Period: Low Dose Atogepant (12-17 yrs)Experimental Treatment1 Intervention
Participants aged 12 to 17 will receive oral tablets of low dose atogepant once a day for 12 weeks.
Group VII: Double-Blind Treatment Period: High Dose Atogepant (6-11 yrs)Experimental Treatment1 Intervention
Participants aged 6-11 will receive oral tablets of high dose atogepant once a day for 12 weeks.
Group VIII: Double-Blind Treatment Period: High Dose Atogepant (12-17 yrs)Experimental Treatment1 Intervention
Participants aged 12 to 17 will receive oral tablets of high dose atogepant once a day for 12 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atogepant
2018
Completed Phase 4
~3490
Find a Location
Who is running the clinical trial?
AbbVieLead Sponsor
958 Previous Clinical Trials
501,934 Total Patients Enrolled
10 Trials studying Migraine
7,659 Patients Enrolled for Migraine
ABBVIE INC.Study DirectorAbbVie
397 Previous Clinical Trials
146,648 Total Patients Enrolled
10 Trials studying Migraine
7,659 Patients Enrolled for Migraine
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had specific severe migraines, as defined by a 2018 standard.I am between 6 to 11 years old and need preventive treatment for my migraines.I have been diagnosed with a specific type of severe headache or facial pain.My weight is between 44 lbs and 298 lbs.I experience 4 to 14 migraine days and less than 15 headache days in a month.I have been diagnosed with chronic migraines.I have been diagnosed with migraines, with or without aura, for at least 6 months.I've been hospitalized for migraine 3+ times in the last 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Double-Blind Treatment Period: Low Dose Atogepant (12-17 yrs)
- Group 2: Open-Label PK Substudy: Atogepant Dose A (6-11 yrs)
- Group 3: Open-Label PK Substudy: Atogepant Dose B (6-11 yrs)
- Group 4: Double-Blind Treatment Period: Low Dose Atogepant (6-11 yrs)
- Group 5: Double-Blind Treatment Period: High Dose Atogepant (6-11 yrs)
- Group 6: Double-Blind Treatment Period: Placebo (12-17 yrs)
- Group 7: Double-Blind Treatment Period: High Dose Atogepant (12-17 yrs)
- Group 8: Double-Blind Treatment Period: Placebo (6-11 yrs)
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this clinical trial include any participants of advanced age?
"The study seeks to enrol participants who are six years old or older, but not yet 17."
Answered by AI
How many geographic areas have been selected to host this research endeavor?
"This trial is taking place in 45 different medical centres, ranging from Little Rock to Lafayette and Anaheim. To reduce potential travel burdens, it would be most sensible for patients to participate at the site nearest them."
Answered by AI
Has the Federal Drug Administration (FDA) sanctioned Open-Label PK Substudy: Atogepant Dose A (6-11 yrs)?
"This Phase 3 trial has accumulated sufficient evidence to rate the safety of Open-Label PK Substudy: Atogepant Dose A (6-11 yrs) as a 3."
Answered by AI
Does this medical experiment have any openings for participants?
"Data housed on clinicaltrials.gov indicates that this particular trial, which was originally posted in February of 2023 and last updated at the end of January, is no longer seeking participants. However, 159 other medical studies are actively recruiting patients currently."
Answered by AI
What prerequisites must individuals meet to be eligible for enrollment in this clinical trial?
"This clinical trial seeks 450 kids aged 6 to 17 who suffer from migraine with aura. Applicants must weigh between 44 lbs and 298 lbs, have a history of episodic migraines (in accordance with the International Classification of Headache Disorders), experience 4-14 migraine days in a 28 day period according to their eDiary, and be eligible for preventive treatment (for those interested in participating in the PK substudy)."
Answered by AI
Who else is applying?
What state do they live in?
Florida
What site did they apply to?
FutureSearch Trials of Neurology /ID# 247470
My Preferred Research LLC /ID# 249720
What portion of applicants met pre-screening criteria?
Did not meet criteria
Why did patients apply to this trial?
I’ve tried many many migraine meds and wish to try something new to help relieve migraines.
PatientReceived 2+ prior treatments
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