CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 71 enrolled
Drug / intervention
Each subject will subcutaneously self-administer TEV 48125 at 225 mg/1.5 mL (150 mg/mL) once monthly for a total of 2 doses.drug
Likely dose
Each subject will subcutaneously self-administer TEV 48125 at 225 mg/1.5 mL (150 mg/mL) once monthly for a total of 2 doses.from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04355117
NCT04355117Phase 3Completed
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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

Otsuka Pharmaceutical Co., Ltd.·interventional·Posted Apr 21, 2020·Updated Oct 28, 2021

In Brief

A Phase 3 clinical trial evaluating Each subject will subcutaneously self-administer TEV 48125 at 225 mg/1.5 mL (150 mg/mL) once monthly for a total of 2 doses. for Migraine. Completed, enrolled 71 participants across 1 site.

Detailed Summary

This trial assesses the safety of TEV-48125 when subcutaneously self-administered in Japanese migraine patients using an autoinjector (AI) at home. Each subject will subcutaneously self-administer TEV 48125 at 225 mg/1.5 mL (150 mg/mL) once monthly for a total of 2 doses. The first dose will be self-administered at the trial site under the supervision of the investigator and the second dose will be self-administered at home.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMigraine
CountriesJapan
Collaborators--

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedApr 21, 2020
Enrollment StartJun 17, 2020
Primary CompletionNov 11, 2020
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 6.2 years ago

Interventions

Each subject will subcutaneously self-administer TEV 48125 at 225 mg/1.5 mL (150 mg/mL) once monthly for a total of 2 doses.drug

Each subject will subcutaneously self-administer TEV 48125 at 225 mg/1.5 mL (150 mg/mL) once monthly for a total of 2 doses.