A Study to Assess the Adverse Events and Change in Disease Activity of Oral Atogepant Tablets in Pediatric Participants (6-17 Years of Age) With Episodic Migraine (Kaleidoscope)

AbbVie

Status and phase: Enrolling; Phase 3

Conditions: Episodic Migraine

Treatments: Drug: Atogepant; Drug: Placebo-Matching Atogepant

Study type: Interventional

Funder types: Industry

Identifiers

NCT05711394

M21-201

2022-501100-94-00 (Other Identifier)

Details and patient eligibility

About

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 pediatric participants. The main goal of the study is to evaluate the safety and efficacy (how well treatment works) of a low-dose and high-dose of atogepant in pediatric participants between the ages of 6 and 17.

Atogepant is a medicine currently approved to treat adults with episodic 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 episodic migraine. This is a Phase 3, randomized, double-blind study of atogepant in participants with a history of episodic migraine with an open-label pharmacokinetic substudy. Eligible participants will be randomized into 6 different groups. Participants between the ages of 12 and 17 will be randomized to receive placebo, low-dose atogepant, or high-dose atogepant for 12 weeks. Participants between the ages of 6 and 11 will also be randomized to receive placebo, low-dose atogepant, or high-dose atogepant for 12 weeks. The specific atogepant doses to be used in participants between the ages of 6 and 11 will be determined after the PK substudy is complete. Around 450 participants will be enrolled in approximately 100 sites.

Placebo, low-dose atogepant, and high-dose atogepant are given as a tablet to take by mouth once a day. At the end of Week 12, participants will either undergo a follow-up visit 4 weeks after last study treatment or join an extension study where they can continue to receive atogepant for another 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.

Enrollment: 450 estimated patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.
• Participant has to have 4 to 14 migraine days and < 15 headache days in the 28-day baseline period per eDiary.
• To be eligible for the PK substudy, participants must be 6 to 11 years of age (inclusive), with a history of migraine and per investigator judgment is appropriate to receive preventive treatment for migraine.

Exclusion criteria

• History of migraine brainstem aura, hemiplegic migraine, or retinal migraine as defined by ICHD-3 (2018).
• Have a current diagnosis of chronic migraine as defined by ICHD-3 (2018).
• Have a current diagnosis of new persistent daily headache, trigeminal autonomic cephalgia (e.g., cluster headache), or painful cranial neuropathy as defined by ICHD-3 (2018).
• Have required in-hospital (excluding emergency department visits) treatment for migraine 3 or more times in the 6 months prior to Visit 1.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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450 participants in 8 patient groups

Open-Label PK Substudy: Atogepant Dose A (6-11 yrs)

Experimental group

Description:

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.

Treatment:

Drug: Atogepant

Open-Label PK Substudy: Atogepant Dose B (6-11 yrs)

Experimental group

Description:

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.

Treatment:

Drug: Atogepant

Double-Blind Treatment Period: High Dose Atogepant (12-17 yrs)

Experimental group

Description:

Participants aged 12 to 17 will receive oral tablets of high dose atogepant once a day for 12 weeks.

Treatment:

Drug: Atogepant

Double-Blind Treatment Period: Placebo (12-17 yrs)

Experimental group

Description:

Participants aged 12 to 17 will receive oral tablets of placebo-matching atogepant once a day for 12 weeks.

Treatment:

Drug: Placebo-Matching Atogepant

Double-Blind Treatment Period: Low Dose Atogepant (12-17 yrs)

Experimental group

Description:

Participants aged 12 to 17 will receive oral tablets of low dose atogepant once a day for 12 weeks.

Treatment:

Drug: Atogepant

Double-Blind Treatment Period: High Dose Atogepant (6-11 yrs)

Experimental group

Description:

Participants aged 6-11 will receive oral tablets of high dose atogepant once a day for 12 weeks.

Treatment:

Drug: Atogepant

Double-Blind Treatment Period: Placebo (6-11 yrs)

Experimental group

Description:

Participants aged 6 to 11 will receive oral tablets of placebo-matching atogepant once a day for 12 weeks.

Treatment:

Drug: Placebo-Matching Atogepant

Double-Blind Treatment Period: Low Dose Atogepant (6-11 yrs)

Experimental group

Description:

Participants aged 6-11 will receive oral tablets of low dose atogepant once a day for 12 weeks.

Treatment:

Drug: Atogepant