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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

NCT04829747 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2023-05-24

Study results available
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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

Interventions

DRUG

Atogepant

Oral Tablet

Sponsors & Collaborators

  • Allergan

    lead INDUSTRY

Principal Investigators

  • ALLERGAN INC. · Allergan

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-02
Primary Completion
2022-01-20
Completion
2022-01-20
FDA Drug
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04829747 on ClinicalTrials.gov