Specified Drug Use Survey on AJOVY Subcutaneous Injection for Long-term Use (NCT05342493) | Clinical Trial Compass
RecruitingNot Applicable
Specified Drug Use Survey on AJOVY Subcutaneous Injection for Long-term Use
Japan1,000 participantsStarted 2022-04-20
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
\-
Exclusion Criteria:
* patients with a known hypersensitivity to components of AJOVY
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety information (Adverse Event)
Timeframe: 2 years from the start date of treatment
2
Number of Special Situations
Timeframe: 2 years from the start date of treatment
3
Number of off-Label Use
Timeframe: 2 years from the start date of treatment
4
Incidence of Serious Adverse Event (e.g. resulting in death or life-threatening)
Timeframe: 2 years from the start date of treatment
5
Incidence of Non-serious Adverse Events (i.e. all Adverse Events that do not meet the definition of a serious Adverse Event)
Timeframe: 2 years from the start date of treatment
Trial details
NCT IDNCT05342493
SponsorOtsuka Pharmaceutical Co., Ltd.
Sponsor typeINDUSTRY
Study typeOBSERVATIONAL
Primary completion2026-09-30
Contact for this trial
Pharmacovigilance Department Otsuka Pharmaceutical Co., Ltd