Long-term Extension Study to Assess Adverse Events of Oral Atogepant Tablets in Pediatric Participants (6 to 17 Years of Age) With Episodic Migraine

JRCT ID: jRCT2051240027

Registered date:09/05/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Episodic Migraine
• Date of first enrollment: 09/05/2024
• Target sample size: 25
• 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 for 52 weeks

Outcome(s)

Primary Outcome

Percentage of Participants with Adverse Events (AEs) [Time Frame: Up to 56 Weeks]
AE, defined as any unfavorable medical event that is temporarily related to the use of the investigational product, which does not necessarily have a causal relationship with the investigational product.
Percentage of Participants with Potentially Clinically Significant Lab Values [Time Frame: Up to 52 Weeks]
Percentage of participants with abnormal change in clinical laboratory test results like hematology, chemistry and urinalysis will be assessed.
Percentage of Participants with Potentially Clinically Significant Clinical 12-lead Electrocardiogram (ECG) [Time Frame: Up to 52 Weeks]
12-lead resting ECGs will be recorded. Parameters include heart rate, PR interval, QT interval, QRS duration, and QT interval corrected using Fridericia's formula (QTcF).
Percentage of Participants with Potentially Clinically Significant Vital Sign Parameters [Time Frame: Up to 52 Weeks]
Number of participants with abnormal change from baseline in vital sign measurements like systolic and diastolic blood pressure will be assessed.
Percentage of with Participants with Treatment-Emergent Suicidal Ideations with Intent, with or without a Plan (i.e., Type 4 or 5 on Columbia-Suicide Severity Rating Scale [C-SSRS]), or any Suicidal Behaviors [Time Frame: Up to 52 Weeks]
The C-SSRS is a clinician-rated instrument that reports the severity of both suicidal ideation and behavior. Suicidal ideation was classified on a 5-item scale: 1 (wish to be dead), 2 (nonspecific active suicidal thoughts), 3 (active suicidal ideation with any methods [not plan] without intent to act), 4 (active suicidal ideation with some intent to act, without specific plan), and 5 (active suicidal ideation with specific plan and intent). Suicidal behavior is classified on a 5-item scale: 0 (no suicidal behavior), 1 (preparatory acts or behavior), 2 (aborted attempt), 3 (interrupted attempt), and 4 (actual attempt).
Percentage of Participants with Change in Menstrual Cycle (Female Participants Only) [Time Frame: Up to 52 Weeks]
Female participants who have entered menarche are to be asked for the date of the first and last day of their most recent menstrual period.
Change from Baseline in Tanner Staging Score [Time Frame: Baseline (Week 0) through Week 52]
Tanner's staging is used to assess growth and pubertal development.
Change from Baseline in Behavior Rating Inventory of Executive Function, 2nd Edition (BRIEF 2) questionnaire [Time Frame: Baseline (Week 0) through Week 52]
The BRIEF 2 is an 86-item questionnaire assessing executive function. It consists of 2 indexes, Behavioral Regulation and Metacognition, which are then used to calculate an overall composite score. Higher scores indicate more executive difficulties

Key inclusion & exclusion criteria

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

Include criteria

Participants must be between 6 and 17 years of age (inclusive), with a history of episodic migraine.
The participant must have completed the lead-in Study M21-201, the pharmacokinetic (PK) substudy in Study M21-201, or completed the 4-week screening/baseline period and screen failed due to not meeting the number of migraine day requirements for the inclusion criteria in Study M21-201, and, in the judgment of the investigator, the participant is an appropriate candidate to be treated with a daily preventive migraine treatment with atogepant (not applicable for de novo migraine participants)
Weight is >= 20 kg (44 lbs) and < 135 kg (298 lbs).
A history of migraine with or without aura consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition (ICHD-3; 2018) for at least 6 months.

Exclude criteria

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).
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 any clinically significant hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal, cardiovascular, or neurologic disease.

Related Information

• Primary Sponsor: Otani Tetsuya
• Secondary ID(s): NCT05707949