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

NCT04829747 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 3101-311-002
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 3

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.

Conditions

Chronic Migraine

Keywords

Chronic Migraine; Migraine; Atogepant; AGN-241689

Outcome Measures

Primary Outcomes (5)

• 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.

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

Study Arms (1)

Atogepant

EXPERIMENTAL

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

Drug: Atogepant

Interventions

Atogepant DRUG

Oral Tablet

Atogepant

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Allergan: lead

Study Sites (3)

Chinese PLA General Hospital /ID# 227546

Beijing, Beijing Municipality, 100853, China

Location

The Second Hospital of Shanxi Medical University /ID# 227567

Taiyuan, Shanxi, 030000, China

Location

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

Hangzhou, Zhejiang, 310009, China

Location

MeSH Terms

Conditions

Migraine Disorders

Interventions

atogepant

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

800-633-9110

Study Officials

• ALLERGAN INC.

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2021
• First Posted: April 2, 2021
• Study Start: August 2, 2021
• Primary Completion: January 20, 2022
• Study Completion: January 20, 2022
• Last Updated: May 24, 2023
• Results First Posted: May 24, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: For details on when studies are available for sharing, please refer to the link below
• 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.

Locations

CN (3)