片頭痛患者におけるTEV-48125の自己投与に関する安全性評価試験

基本情報

NCT ID: NCT04355117
ステータス: 完了
試験のフェーズ: 第3相
試験タイプ: 介入
目標被験者数: 71
治験依頼者名: Otsuka Pharmaceutical Co., Ltd.

概要

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.

対象疾患

Migraine

介入

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)

依頼者（Sponsor）

大塚製薬株式会社(INDUSTRY)

実施施設 (1)

Sendai Zutsu No-Shinkei Clinic

Sendai, Japan