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

Conditions

• Episodic Migraine

Eligibility Criteria

Sex

ALL

Age

6 Years - 17 Years

Healthy Volunteers

Not accepted

Interventions

• Atogepant — DRUG
  Oral Tablet
• Placebo-Matching Atogepant — DRUG
  Oral Tablet

Study Details

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 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 worldwide. 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.

Key Dates

Start date

May 1, 2023

Status verified

May 2026

Primary completion

Mar 31, 2028

Completion

May 31, 2028

Study Design

Enrollment

450 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Open-Label PK Substudy: Atogepant Dose A (6-11 yrs)
  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.
• Experimental: Open-Label PK Substudy: Atogepant Dose B (6-11 yrs)
  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.
• Experimental: Double-Blind Treatment Period: High Dose Atogepant (12-17 yrs)
  Participants aged 12 to 17 will receive oral tablets of high dose atogepant once a day for 12 weeks.
• Placebo Comparator: Double-Blind Treatment Period: Placebo (12-17 yrs)
  Participants aged 12 to 17 will receive oral tablets of placebo-matching atogepant once a day for 12 weeks.
• Experimental: Double-Blind Treatment Period: Low Dose Atogepant (12-17 yrs)
  Participants aged 12 to 17 will receive oral tablets of low dose atogepant once a day for 12 weeks.
• Experimental: Double-Blind Treatment Period: High Dose Atogepant (6-11 yrs)
  Participants aged 6-11 will receive oral tablets of high dose atogepant once a day for 12 weeks.
• Placebo Comparator: Double-Blind Treatment Period: Placebo (6-11 yrs)
  Participants aged 6 to 11 will receive oral tablets of placebo-matching atogepant once a day for 12 weeks.
• Experimental: Double-Blind Treatment Period: Low Dose Atogepant (6-11 yrs)
  Participants aged 6-11 will receive oral tablets of low dose atogepant once a day for 12 weeks.

Primary Outcome Measure

Change from Baseline in Mean Monthly Migraine Days [ Time Frame: Baseline (Week 0) through Week 12 ]

Central Contacts

• ABBVIE CALL CENTER
  844-663-3742
  [email protected]

Locations (42)

Find similar trials in Huntsville, AL

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