Specified Drug Use Survey on AJOVY Subcutaneous Injection for Long-term Use

NCT ID: NCT05342493

Last Updated: 2025-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-20

Study Completion Date

2029-06-22

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To evaluate the long-term safety of AJOVY in patients under actual use conditions and to specifically evaluate cardiovascular events. In addition, information on efficacy will be collected.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Migraine Disorders

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Drug

Ajovy syringe for SC injection 225 mg.

Fremanezumab 225 Mg/1.5 mL Subcutaneous Solution

Intervention Type DRUG

The usual adult dose is 225 mg of fremanezumab (genetical recombination) administered subcutaneously as a single dose once every 4 weeks or 675 mg administered subcutaneously as a single dose once every 12 weeks.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Fremanezumab 225 Mg/1.5 mL Subcutaneous Solution

The usual adult dose is 225 mg of fremanezumab (genetical recombination) administered subcutaneously as a single dose once every 4 weeks or 675 mg administered subcutaneously as a single dose once every 12 weeks.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

\-

Exclusion Criteria

* patients with a known hypersensitivity to components of AJOVY
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Otsuka Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Yasuhiko Fukuta, PhD

Role: STUDY_DIRECTOR

Otsuka Pharmaceutical Co., Ltd.

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Pharmacovigilance Department

Osaka, , Japan

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Japan

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Pharmacovigilance Department Otsuka Pharmaceutical Co., Ltd

Role: CONTACT

+81-6-6943-7722

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Satoshi Komaniwa, PhD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

406-101-00013

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Assessment of LBR-101 In Chronic Migraine
NCT02021773 COMPLETED PHASE2