Migraine DisordersNCT05342493
Specified Drug Use Survey on AJOVY Subcutaneous Injection for Long-term Use
An observational study of Migraine Disorders, run by Otsuka Pharmaceutical Co., Ltd. at 1 site in Japan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine Disorders
- What is being tested?
- Fremanezumab 225 Mg/1.5 mL Subcutaneous Solution
- Type of treatment
- Injection or infusion
- How many people
- 1,000 participants
- Where
- 1 siteJapan
- Study dates
- 20 Apr 2022to 22 Jun 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients in Japan who are planned to be newly started on Ajovy syringe for SC injection 225 mg therapy for the suppression of migraine attacks
Who may be able to join
- -
Who cannot join
- patients with a known hypersensitivity to components of AJOVY
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pharmacovigilance Department Otsuka Pharmaceutical Co., Ltd contact
Japan1 site, 1 recruiting
- Recruiting
Pharmacovigilance Department
Osaka, 540-0021
Satoshi Komaniwa, PhD
About this study
Official title: AJOVY Subcutaneous Injection Long-term Specified Use-results Survey
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.
- Conditions
- Migraine Disorders
- Being tested
- Fremanezumab 225 Mg/1.5 mL Subcutaneous Solution
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fremanezumab 225 Mg/1.5 mL Subcutaneous SolutionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Drug | Ajovy syringe for SC injection 225 mg. Receives: Drug: Fremanezumab 225 Mg/1.5 mL Subcutaneous Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety information (Adverse Event)
Any untoward medicinal occurrence in a patient or clinical study subject administered a Medicinal Product and which does not necessarily have a causal relationship with this treatment (see Annex Ⅳ, ICH-E2A Guideline).
An Adverse Event can therefore be any unfavorable and unintended sign (e.g. abnormal laboratory finding), symptom, or disease temporally associated with the use of a Medicinal Product, whether or not it is considered causally related to the Medicinal Product.
Measured: 2 years from the start date of treatment
Number of Special Situations
Collecting any Situations related to the use of an Otsuka product which may or may not be associated with an adverse event:
- Maternal (pregnancy and breastfeeding) or paternal (via semen) exposure;
- Exposure during breastfeeding;
- Overdose/Incorrect dosage, misuse, abuse (e.g. patient sharing products);
- Medication errors (e.g. patient took wrong dose);
- Lack of therapeutic efficacy (e.g. the product doesn't work);
- Occupational exposure (e.g.: nurse administering the product is exposed);
- Cases of suspected transmission of infectious agents;
- Use of suspected or confirmed falsified product(s) or quality defect of the product(s);
- Withdrawal reactions;
- Accidental exposure (e.g.: child takes parent's product);
- Drug-drug/drug-food interactions;
- Unintentional use of product in a non-approved population (e.g.: pediatric or geriatric population);
- Disease progression/exacerbation of existing disease
Measured: 2 years from the start date of treatment
Number of off-Label Use
Collecting any type of off-Label Use that refers to situations where a product is intentionally used for a medical purpose not in accordance with the authorized product information. Off-label use also includes the intentional use in non-authorized population categories not indicated in the label.
Measured: 2 years from the start date of treatment
Incidence of Serious Adverse Event (e.g. resulting in death or life-threatening)
Collecting the number of any adverse drug experience/event occurring at any dose which
- results in death
- is life-threatening
- requires inpatient hospitalization or prolonged of existing hospitalization
- results in persistent or significant disability or incapacity
- is a congenital anomaly/birth defect
- is medically significant.
Measured: 2 years from the start date of treatment
Incidence of Non-serious Adverse Events (i.e. all Adverse Events that do not meet the definition of a serious Adverse Event)
Collecting the number of non-serious Adverse Events
Measured: 2 years from the start date of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start20 Apr 2022
- Primary completion30 Sep 2026 (estimated)
- Study completion22 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine DisordersStudies of the same condition, open and under way.
- More trials run by Otsuka Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yasuhiko Fukuta, PhD, Study director, Otsuka Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05342493
- Sponsor's protocol ID
- 406-101-00013
- Status last verified
- Jun 2026
- First submitted
- 17 Apr 2022
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AJOVY Subcutaneous Injection Long-term Specified Use-results Survey
- ClinicalTrials.gov ID
- NCT05342493
- Acronym / sponsor ID
- 406-101-00013
- Conditions
- Migraine Disorders
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Apr 2022 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 22 Jun 2029 (estimated)
- First posted
- 22 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Drug | – | Drug: Fremanezumab 225 Mg/1.5 mL Subcutaneous SolutionAjovy syringe for SC injection 225 mg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in Japan who are planned to be newly started on Ajovy syringe for SC injection 225 mg therapy for the suppression of migraine attacks
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (1 listed)
- patients with a known hypersensitivity to components of AJOVY
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fremanezumab 225 Mg/1.5 mL Subcutaneous SolutionThe 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. | Drug | Drug |
Primary outcome
Safety information (Adverse Event)
Time frame: 2 years from the start date of treatment
Any untoward medicinal occurrence in a patient or clinical study subject administered a Medicinal Product and which does not necessarily have a causal relationship with this treatment (see Annex Ⅳ, ICH-E2A Guideline). An Adverse Event can therefore be any unfavorable and unintended sign (e.g. abnormal laboratory finding), symptom, or disease temporally associated with the use of a Medicinal Product, whether or not it is considered causally related to the Medicinal Product.
Number of Special Situations
Time frame: 2 years from the start date of treatment
Collecting any Situations related to the use of an Otsuka product which may or may not be associated with an adverse event: * Maternal (pregnancy and breastfeeding) or paternal (via semen) exposure; * Exposure during breastfeeding; * Overdose/Incorrect dosage, misuse, abuse (e.g. patient sharing products); * Medication errors (e.g. patient took wrong dose); * Lack of therapeutic efficacy (e.g. the product doesn't work); * Occupational exposure (e.g.: nurse administering the product is exposed); * Cases of suspected transmission of infectious agents; * Use of suspected or confirmed falsified product(s) or quality defect of the product(s); * Withdrawal reactions; * Accidental exposure (e.g.: child takes parent's product); * Drug-drug/drug-food interactions; * Unintentional use of product in a non-approved population (e.g.: pediatric or geriatric population); * Disease progression/exacerbation of existing disease
Number of off-Label Use
Time frame: 2 years from the start date of treatment
Collecting any type of off-Label Use that refers to situations where a product is intentionally used for a medical purpose not in accordance with the authorized product information. Off-label use also includes the intentional use in non-authorized population categories not indicated in the label.
Incidence of Serious Adverse Event (e.g. resulting in death or life-threatening)
Time frame: 2 years from the start date of treatment
Collecting the number of any adverse drug experience/event occurring at any dose which * results in death * is life-threatening * requires inpatient hospitalization or prolonged of existing hospitalization * results in persistent or significant disability or incapacity * is a congenital anomaly/birth defect * is medically significant.
Incidence of Non-serious Adverse Events (i.e. all Adverse Events that do not meet the definition of a serious Adverse Event)
Time frame: 2 years from the start date of treatment
Collecting the number of non-serious Adverse Events
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pharmacovigilance Department Otsuka Pharmaceutical Co., Ltd contact
Yasuhiko Fukuta, PhD study director
Otsuka Pharmaceutical Co., Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine Disorders, run by Otsuka Pharmaceutical Co., Ltd. at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pharmacovigilance Department Otsuka Pharmaceutical Co., Ltd (+81-6-6943-7722, komaniwa.satoshi@otsuka.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety information (Adverse Event) (time frame: 2 years from the start date of treatment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.