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A safety evaluation trial of TEV-48125 self-administered in migraine patients

A multicenter, open-label trial to evaluate the safety of TEV-48125 when subcutaneously self-administered in migraine patients at the trial site and at home

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080225136
Enrollment
50
Registered
2020-03-19
Start date
2020-06-17
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Migraine

Interventions

investigational material(s) Generic name etc : TEV-48125 INN of investigational material : - Therapeutic category code : 119 Other agents affecting central nervous system Dosage and Administration for

Sponsors

Otsuka Pharmaceutical Co., LTD.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patient has a history of migraine (according to The International Classification of Headache Disorders, ICHD)or clinical judgment suggests a migraine diagnosis (not better accounted for by another ICHD diagnosis) for 12 months or over prior to informed consent.

Exclusion criteria

Exclusion criteria: The patient cannot participate or successfully complete the trial for other reasons in the opinion of the investigator.

Design outcomes

Primary

MeasureTime frame
safety Occurrence of adverse events

Secondary

MeasureTime frame
other Evaluation of the execution status of self-administration at home

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026