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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atogepant | Experimental | Participants will receive fixed dose of Atogepant once daily for 12 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atogepant | Drug | Oral Tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline of the study 3101-303-002 to 16 weeks |
| 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. | Baseline of the study 3101-303-002 to 16 weeks |
| 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. | Baseline of the study 3101-303-002 to 16 weeks |
| Number of Participants With Significant Change in Electrocardiogram (ECG) Parameters | 12-lead ECG will be performed. | Baseline of the study 3101-303-002 to 12 weeks |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ALLERGAN INC. | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese PLA General Hospital /ID# 227546 | Beijing | Beijing Municipality | 100853 | China | ||
| The Second Hospital of Shanxi Medical University /ID# 227567 |
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
For details on when studies are available for sharing, please refer to the link below
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Atogepant | Participants will receive fixed dose of Atogepant once daily for 12 weeks. Atogepant: Oral Tablet |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 6, 2020 | Jan 23, 2023 |
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| Baseline of the study 3101-303-002 to 16 weeks |
| Taiyuan |
| Shanxi |
| 030000 |
| China |
| The second Affiliated hospital of Zhejiang University school of Medicine /ID# 227558 | Hangzhou | Zhejiang | 310009 | China |
| COMPLETED |
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| NOT COMPLETED |
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The safety population, consisting of all participants who received at least 1 dose of study intervention (atogepant) in this extension study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Atogepant | Participants will receive fixed dose of Atogepant once daily for 12 weeks. Atogepant: Oral Tablet |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Safety population: all subjects who received ≥1 dose of the study treatment (atogepant) in this extension study | Posted | Count of Participants | Participants | Baseline of the study 3101-303-002 to 16 weeks |
|
|
| ||||||||||||||||||||||||||
| 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. | Safety population: all subjects who received ≥1 dose of the study treatment (atogepant) in this extension study | Posted | Count of Participants | Participants | Baseline of the study 3101-303-002 to 16 weeks |
|
| |||||||||||||||||||||||||||
| 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. | Safety population: all subjects who received ≥1 dose of the study treatment (atogepant) in this extension study | Posted | Count of Participants | Participants | Baseline of the study 3101-303-002 to 16 weeks |
|
| |||||||||||||||||||||||||||
| Primary | Number of Participants With Significant Change in Electrocardiogram (ECG) Parameters | 12-lead ECG will be performed. | Safety population: all subjects who received ≥1 dose of the study treatment (atogepant) in this extension study | Posted | Count of Participants | Participants | Baseline of the study 3101-303-002 to 12 weeks |
|
| |||||||||||||||||||||||||||
| 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. | Safety population: all subjects who received ≥1 dose of the study treatment (atogepant) in this extension study | Posted | Count of Participants | Participants | Baseline of the study 3101-303-002 to 16 weeks |
|
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Atogepant | Participants will receive fixed dose of Atogepant once daily for 12 weeks. Atogepant: Oral Tablet | 0 | 3 | 0 | 3 | 1 | 3 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| DYSMENORRHEA | Reproductive system and breast disorders | MedDRA 24.0 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 | abbvieclinicaltrials@abbvie.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 31, 2022 | Jan 23, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C000718987 | atogepant |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Title | Denominators | Categories | ||||
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