Trial Outcomes & Findings for Study to Assess Adverse Events (AEs) When Oral Atogepant Tablet is Given to Adult Chinese Participants Who Completed Study 3101-303-002 to Prevent Chronic Migraine (NCT NCT04829747)

NCT ID: NCT04829747

Last Updated: 2023-05-24

Results Overview

An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

3 participants

Primary outcome timeframe

Baseline of the study 3101-303-002 to 16 weeks

Results posted on

2023-05-24

Participant Flow

A total of 2 subjects were included in the modified intent-to-treat (mITT) population, defined as all subjects who received ≥1 dose of study treatment (atogepant) in this extension study and had ≥1 evaluable postbaseline 4-week period of electronic diary (eDiary) data in this extension study. A total of 3 subjects were included in the safety population, defined as all subjects who received ≥1 dose of the study treatment (atogepant) in this extension study.

Participant milestones

Participant milestones
Measure	Atogepant Participants will receive fixed dose of Atogepant once daily for 12 weeks. Atogepant: Oral Tablet
Overall Study STARTED	3
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Atogepant Participants will receive fixed dose of Atogepant once daily for 12 weeks. Atogepant: Oral Tablet
Overall Study Protocol Violation	1

Baseline Characteristics

Study to Assess Adverse Events (AEs) When Oral Atogepant Tablet is Given to Adult Chinese Participants Who Completed Study 3101-303-002 to Prevent Chronic Migraine

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Atogepant n=3 Participants Participants will receive fixed dose of Atogepant once daily for 12 weeks. Atogepant: Oral Tablet
Age, Customized Years of Age · 33 Years Old	1 Participants n=5 Participants
Age, Customized Years of Age · 41 Years Old	1 Participants n=5 Participants
Age, Customized Years of Age · 51 Years Old	1 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment China	3 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline of the study 3101-303-002 to 16 weeks

Population: Safety population: all subjects who received ≥1 dose of the study treatment (atogepant) in this extension study

An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity.

Outcome measures

Outcome measures
Measure	Atogepant n=3 Participants Participants will receive fixed dose of Atogepant once daily for 12 weeks. Atogepant: Oral Tablet
Number of Participants With Adverse Events	1 Participants

PRIMARY outcome

Timeframe: Baseline of the study 3101-303-002 to 16 weeks

Population: Safety population: all subjects who received ≥1 dose of the study treatment (atogepant) in this extension study

Number of participants with clinically significant change from baseline for any detectable clinical laboratory tests like hematology will be reported.

Outcome measures

Outcome measures
Measure	Atogepant n=3 Participants Participants will receive fixed dose of Atogepant once daily for 12 weeks. Atogepant: Oral Tablet
Number of Participants With Significant Change in Clinical Laboratory Determinations	0 Participants

PRIMARY outcome

Timeframe: Baseline of the study 3101-303-002 to 16 weeks

Population: Safety population: all subjects who received ≥1 dose of the study treatment (atogepant) in this extension study

Number of participants with clinically significant change from baseline for any vital signs like standing BP, sitting and standing pulse rate will be reported.

Outcome measures

Outcome measures
Measure	Atogepant n=3 Participants Participants will receive fixed dose of Atogepant once daily for 12 weeks. Atogepant: Oral Tablet
Number of Participants With Significant Change in Vital Sign Measurements	0 Participants

PRIMARY outcome

Timeframe: Baseline of the study 3101-303-002 to 12 weeks

Population: Safety population: all subjects who received ≥1 dose of the study treatment (atogepant) in this extension study

12-lead ECG will be performed.

Outcome measures

Outcome measures
Measure	Atogepant n=3 Participants Participants will receive fixed dose of Atogepant once daily for 12 weeks. Atogepant: Oral Tablet
Number of Participants With Significant Change in Electrocardiogram (ECG) Parameters	0 Participants

PRIMARY outcome

Timeframe: Baseline of the study 3101-303-002 to 16 weeks

Population: Safety population: all subjects who received ≥1 dose of the study treatment (atogepant) in this extension study

The C-SSRS is a clinician-rated instrument that reports the severity of both suicidal ideation and behavior. Suicidal ideation is classified on a 5-item scale: 1 being wish to be dead and 5 being active suicidal ideation with specific plan and intent. Suicidal behavior is classified on a 5-item scale: 0 being no suicidal behavior and 4 being actual attempt.

Outcome measures

Outcome measures
Measure	Atogepant n=3 Participants Participants will receive fixed dose of Atogepant once daily for 12 weeks. Atogepant: Oral Tablet
Number of Participants With a Change in Columbia-Suicide Severity Rating Scale (C-SSRS)	0 Participants

Adverse Events

Atogepant

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Atogepant n=3 participants at risk Participants will receive fixed dose of Atogepant once daily for 12 weeks. Atogepant: Oral Tablet
Reproductive system and breast disorders DYSMENORRHEA	33.3% 1/3 • Number of events 1 • Up to 16 Weeks An AE was considered a treatment-emergent adverse event (TEAE) if it began or worsened (increased in severity or became serious) on or after the date of the first dose of double-blind study treatment in the lead-in study. TEAEs could have been identified as those AEs captured in this study with recorded onset date on or after the date of the first dose of lead-in double-blind study treatment and within 30 days after the last dose of open-label study treatment or Visit 5, whichever came later.
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	33.3% 1/3 • Number of events 1 • Up to 16 Weeks An AE was considered a treatment-emergent adverse event (TEAE) if it began or worsened (increased in severity or became serious) on or after the date of the first dose of double-blind study treatment in the lead-in study. TEAEs could have been identified as those AEs captured in this study with recorded onset date on or after the date of the first dose of lead-in double-blind study treatment and within 30 days after the last dose of open-label study treatment or Visit 5, whichever came later.

Additional Information

Global Medical Services

AbbVie

Phone: 800-633-9110

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
Publication restrictions are in place

Restriction type: OTHER