What side effects are associated with this type of intervention?

Common treatments for migraines, particularly CGRP receptor antagonists like Atogepant, often include side effects such as nausea, constipation, and fatigue. Other treatments for migraines, such as triptans, can cause dizziness, dry mouth, and chest discomfort. Preventive medications like topiramate may lead to weight loss, cognitive disturbances, and tingling sensations. It is important to discuss these potential side effects with a healthcare provider to determine the most appropriate treatment plan.

What prior FDA approvals exist?

The FDA has approved several treatments for migraine, including CGRP receptor antagonists like Atogepant. Other similar drugs include Erenumab (Aimovig), Fremanezumab (Ajovy), and Galcanezumab (Emgality), which are used for the preventive treatment of migraine. These medications work by blocking the calcitonin gene-related peptide (CGRP) receptor, which plays a key role in migraine pathophysiology. These treatments have shown efficacy in reducing the frequency and severity of migraine attacks in clinical trials.

What other types of research exist?

Promising novel alternatives to Atogepant for migraine patients include Ubrogepant and Lasmiditan. Ubrogepant is another CGRP receptor antagonist shown to be effective in acute migraine treatment. Lasmiditan, a serotonin (5-HT1F) receptor agonist, is also approved for acute migraine treatment and offers a different mechanism of action. Both have demonstrated efficacy and safety in clinical trials.

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CGRP Antagonist

Oral Atogepant Tablets for Migraine (Kaleidoscope Trial)

Q: What is the mechanism of action of this treatment?

CGRP receptor antagonists, such as Atogepant, work by blocking the calcitonin gene-related peptide (CGRP) receptors, which play a crucial role in mediating trigeminovascular pain transmission and neurogenic inflammation associated with migraines. This mechanism helps reduce the frequency and severity of migraine attacks. Other common treatments include NSAIDs and acetaminophen, which alleviate pain by reducing inflammation and blocking pain signals, and triptans, which activate serotonin receptors to constrict blood vessels and reduce inflammation. Understanding these mechanisms is vital for migraine patients as it helps tailor treatment plans to effectively manage symptoms and improve quality of life.

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.

Must not have

History of migraine aura with diplopia or impairment of level of consciousness, hemiplegic migraine, or retinal migraine as defined by ICHD-3 (2018).

Have a current diagnosis of chronic migraine as defined by ICHD-3 (2018).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (week 0) to 3 months

Awards & highlights

Pivotal Trial

Summary

This trial is testing a medication called atogepant to treat migraines in children and teenagers aged 6 to 17. The study aims to see if atogepant is safe and effective for this age group. Atogepant helps by blocking a protein that triggers migraines, potentially reducing their occurrence and intensity. Atogepant is a newly approved oral medication for the prevention of episodic migraine in adults.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My weight is between 44 lbs and 298 lbs.

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I have been diagnosed with migraines, with or without aura, for at least 6 months.

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I experience 4 to 14 migraine days and less than 15 headache days in a month.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had specific severe migraines, as defined by a 2018 standard.

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I have been diagnosed with chronic migraines.

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I have been diagnosed with a specific type of severe headache or facial pain.

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I've been hospitalized for migraine 3+ times in the last 6 months.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (week 0) to 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from Baseline in Mean Monthly Migraine Days

Secondary study objectives

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 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

CGRP receptor antagonists, such as Atogepant, work by blocking the calcitonin gene-related peptide (CGRP) receptors, which play a crucial role in mediating trigeminovascular pain transmission and neurogenic inflammation associated with migraines. This mechanism helps reduce the frequency and severity of migraine attacks. Other common treatments include NSAIDs and acetaminophen, which alleviate pain by reducing inflammation and blocking pain signals, and triptans, which activate serotonin receptors to constrict blood vessels and reduce inflammation. Understanding these mechanisms is vital for migraine patients as it helps tailor treatment plans to effectively manage symptoms and improve quality of life.

Prevention of migraine with monoclonal antibodies against CGRP or the CGRP receptor: Addition to the S1 guideline: Therapy of migraine attacks and prevention of migraine. Recommendations of the Germany Society of Neurology and the German Migraine and Headache Society.Calcitonin gene-related peptide receptor antagonists for migraine.