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

Migraine Disorders Clinical Trial

Official title:

AJOVY Subcutaneous Injection Long-term Specified Use-results Survey

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05342493
• Other study ID #: 406-101-00013
• Status: Recruiting
• Start date: April 20, 2022
• Est. completion date: June 22, 2029

Study information

• Verified date: November 2023
• Source: Otsuka Pharmaceutical Co., Ltd.
• Contact: Pharmacovigilance Department Otsuka Pharmaceutical Co., Ltd
• Phone: +81-6-6943-7722
• Email: komaniwa.satoshi[@]otsuka.jp
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: June 22, 2029
• Est. primary completion date: September 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

-

Exclusion Criteria:

• patients with a known hypersensitivity to components of AJOVY

Related Conditions & MeSH terms

• Migraine Disorders

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Japan	Pharmacovigilance Department	Osaka

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 ?, 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.	2 years from the start date of treatment
Primary	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	2 years from the start date of treatment
Primary	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.	2 years from the start date of treatment
Primary	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.	2 years from the start date of treatment
Primary	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	2 years from the start date of treatment