Chronic Migraine
Conditions
Keywords
Chronic Migraine, Migraine, Atogepant, AGN-241689
Brief summary
Migraine is characterized by attacks of throbbing, moderate or severe headache, associated with nausea, vomiting, and/or sensitivity to light and sound. The main objective of the study is to evaluate how safe and effective the atogepant is in preventing chronic migraine in adult Chinese participants who completed study 3101-303-002. Adverse events will be monitored. Atogepant is an investigational drug being developed to prevent chronic migraine. All participants will receive the same treatment. Approximately 120 adult participants who completed study 3101-303-002 will be enrolled at approximately 25 centers in China. All participants will receive atogepant oral tablet once daily for 12 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Interventions
DRUGAtogepant
Oral Tablet
Sponsors
Allergan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Eligible participants completed the double-blind treatment period, and the safety follow-up period, if applicable, depending on the timing of study initiation, of Study 3101-303-002 without significant protocol deviations and who did not experience an adverse event (AE) that, in the investigator's opinion, may indicate an unacceptable safety risk.
Exclusion criteria
* Participants requiring any medication, diet, or nonpharmacological treatment on the list of prohibited concomitant medications or treatments, that cannot be discontinued or switched to an allowable alternative. Concomitant medications with demonstrated efficacy for the prevention of migraine is exclusionary, except that participants from lead-in study 3101-303-002 taking 1 medication with demonstrated efficacy for the prevention of migraine may participate in the current study provided that the dose was stable prior to the lead-in study and the participant is willing to continue taking that medication. * Participants with an electrocardiogram (ECG) indicating clinically significant abnormalities at Visit 1. * Participants with hypertension (sitting systolic blood pressure (BP) \> 160 mm Hg or sitting diastolic BP \> 100 mm Hg) at Visit 1. * Participants with a significant risk of self-harm Columbia-Suicide Severity Rating Scale (C-SSRS), or of harm to others (investigator opinion); participants who report suicidal ideation with intent, with or without a plan, since the last visit, must be excluded. * Participants with clinically significant hematologic, endocrine, cardiovascular, pulmonary, renal, hepatic, gastrointestinal, or neurologic disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events | Baseline of the study 3101-303-002 to 16 weeks | 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. |
| Number of Participants With Significant Change in Clinical Laboratory Determinations | Baseline of the study 3101-303-002 to 16 weeks | Number of participants with clinically significant change from baseline for any detectable clinical laboratory tests like hematology will be reported. |
| Number of Participants With Significant Change in Vital Sign Measurements | Baseline of the study 3101-303-002 to 16 weeks | Number of participants with clinically significant change from baseline for any vital signs like standing BP, sitting and standing pulse rate will be reported. |
| Number of Participants With Significant Change in Electrocardiogram (ECG) Parameters | Baseline of the study 3101-303-002 to 12 weeks | 12-lead ECG will be performed. |
| Number of Participants With a Change in Columbia-Suicide Severity Rating Scale (C-SSRS) | Baseline of the study 3101-303-002 to 16 weeks | 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. |
Countries
China
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Atogepant Participants will receive fixed dose of Atogepant once daily for 12 weeks.
Atogepant: Oral Tablet | 3 |
| Total | 3 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 1 |
Baseline characteristics
| Characteristic | Atogepant |
|---|---|
| Age, Customized Years of Age 33 Years Old | 1 Participants |
| Age, Customized Years of Age 41 Years Old | 1 Participants |
| Age, Customized Years of Age 51 Years Old | 1 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment China | 3 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 3 |
| other Total, other adverse events | 1 / 3 |
| serious Total, serious adverse events | 0 / 3 |
Outcome results
Primary
Number of Participants With a Change in Columbia-Suicide Severity Rating Scale (C-SSRS)
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.
Time frame: 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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Atogepant | Number of Participants With a Change in Columbia-Suicide Severity Rating Scale (C-SSRS) | 0 Participants |
Primary
Number of Participants With Adverse Events
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.
Time frame: 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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Atogepant | Number of Participants With Adverse Events | 1 Participants |
Primary
Number of Participants With Significant Change in Clinical Laboratory Determinations
Number of participants with clinically significant change from baseline for any detectable clinical laboratory tests like hematology will be reported.
Time frame: 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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Atogepant | Number of Participants With Significant Change in Clinical Laboratory Determinations | 0 Participants |
Primary
Number of Participants With Significant Change in Electrocardiogram (ECG) Parameters
12-lead ECG will be performed.
Time frame: 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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Atogepant | Number of Participants With Significant Change in Electrocardiogram (ECG) Parameters | 0 Participants |
Primary
Number of Participants With Significant Change in Vital Sign Measurements
Number of participants with clinically significant change from baseline for any vital signs like standing BP, sitting and standing pulse rate will be reported.
Time frame: 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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Atogepant | Number of Participants With Significant Change in Vital Sign Measurements | 0 Participants |