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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

Primary Purpose

Chronic Migraine

Status

Completed

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Atogepant

About this trial

This is an interventional prevention trial for Chronic Migraine focused on measuring Chronic Migraine, Migraine, Atogepant, AGN-241689

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Chinese PLA General Hospital /ID# 227546
The Second Hospital of Shanxi Medical University /ID# 227567
The second Affiliated hospital of Zhejiang University school of Medicine /ID# 227558

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Atogepant

Arm Description

Participants will receive fixed dose of Atogepant once daily for 12 weeks.

Outcomes

Primary Outcome Measures

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.

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.

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.

Number of Participants With Significant Change in Electrocardiogram (ECG) Parameters

12-lead ECG will be performed.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04829747

First Posted

April 1, 2021

Last Updated

April 28, 2023

Sponsor

Allergan

1. Study Identification

Unique Protocol Identification Number

NCT04829747

Brief Title

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

Official Title

A Phase 3, Multicenter, Open-Label, 12-Week Study to Evaluate the Safety and Tolerability of Oral Atogepant for the Prevention of Migraine in Chinese Participants With Chronic Migraine

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Completed

Study Start Date

August 2, 2021 (Actual)

Primary Completion Date

January 20, 2022 (Actual)

Study Completion Date

January 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Allergan

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Migraine

Keywords

Chronic Migraine, Migraine, Atogepant, AGN-241689

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

3 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Atogepant

Arm Type

Experimental

Arm Description

Participants will receive fixed dose of Atogepant once daily for 12 weeks.

Intervention Type

Drug

Intervention Name(s)

Atogepant

Intervention Description

Oral Tablet

Primary Outcome Measure Information:

Title

Number of Participants With Adverse Events

Description

Time Frame

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

Title

Number of Participants With Significant Change in Clinical Laboratory Determinations

Description

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

Title

Number of Participants With Significant Change in Vital Sign Measurements

Description

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

Title

Number of Participants With Significant Change in Electrocardiogram (ECG) Parameters

Description

12-lead ECG will be performed.

Time Frame

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

Title

Number of Participants With a Change in Columbia-Suicide Severity Rating Scale (C-SSRS)

Description

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

ALLERGAN INC.

Organizational Affiliation

Allergan

Official's Role

Study Director

Facility Information:

Facility Name

Chinese PLA General Hospital /ID# 227546

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100853

Country

China

Facility Name

The Second Hospital of Shanxi Medical University /ID# 227567

City

Taiyuan

State/Province

Shanxi

ZIP/Postal Code

030000

Country

China

Facility Name

The second Affiliated hospital of Zhejiang University school of Medicine /ID# 227558

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310009

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

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.

IPD Sharing Time Frame

For details on when studies are available for sharing, please refer to the link below

IPD Sharing Access Criteria

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.

IPD Sharing URL

https://vivli.org/ourmember/abbvie/

Learn more about this trial

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

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