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

JRCT ID: jRCT2051230212

Registered date:29/03/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Episodic migraine
• Date of first enrollment: 29/03/2024
• Target sample size: 450
• Countries of recruitment: Belgium,Japan,Canada,Japan,Denmark,Japan,France,Japan,Hungary,Japan,Israel,Japan,Italy,Japan,Netherlands,Japan,Poland,Japan,Puerto Rico,Japan,Romania,Japan,Spain,Japan,Sweden,Japan,United Kingdom,Japan,United States,Japan
• Study type: Interventional
• Intervention(s): Atogepant Oral Tablet or Placebo-Matching Atogepant Oral Tablet for 12 weeks

Outcome(s)

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

Key inclusion & exclusion criteria

• Age minimum: >= 6age old
• Age maximum: <= 17age old
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Otani Tetsuya