2022-501100-94-00
Recruiting
Phase 3
A Phase 3, Multicenter, 12-Week, Double Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Atogepant for the Preventive Treatment of Episodic Migraine in Pediatric Subjects 6 to 17 years of age
Abbvie Deutschland GmbH & Co. KG37 sites in 10 countries151 target enrollmentStarted: July 31, 2023Last updated:
Overview
- Phase
- Phase 3
- Status
- Recruiting
- Enrollment
- 151
- Locations
- 37
- Primary Endpoint
- Change from baseline in mean monthly migraine days across the 12-week treatment period.
Overview
Brief Summary
To evaluate the safety and efficacy of two doses of atogepant (low and high) when administered daily for the treatment of episodic migraine in pediatric participants 6 to 17 years of age.
Study Design
- Allocation
- Not Applicable
- Primary Purpose
- Follow-Up Period
- Masking
- None
Eligibility Criteria
- Ages
- 0 years to 17 years (0-17 Years)
- Accepts Healthy Volunteers
- Yes
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 last 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 daily persistent headache, trigeminal autonomic cephalgia (e.g., cluster headache), or painful cranial neuropathy as defined by ICHD-3 (2018).
Outcomes
Primary Outcomes
Change from baseline in mean monthly migraine days across the 12-week treatment period.
Change from baseline in mean monthly migraine days across the 12-week treatment period.
Secondary Outcomes
- Change from baseline in mean monthly headache days across the 12-week treatment period.
- Change from baseline in mean monthly acute medication use days across the 12-week treatment period.
- Achievement of at least a 50% reduction in 3-month average of monthly migraine days.
- Change from baseline in the PedsQL total score at Week 12.
- Change from baseline in the PedMIDAS total score at Week 12.
Investigators
Global Clinical Trials Helpdesk
Scientific
Abbvie Deutschland GmbH & Co. KG
Study Sites (37)
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