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片頭痛の予防治療におけるフレマネズマブ(TEV-48125)の皮下投与の有効性と安全性

基本情報

NCT ID
NCT02638103
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
1,890
治験依頼者名
Teva Branded Pharmaceutical Products R&D, Inc.

概要

A study to evaluate the long-term safety, tolerability, and efficacy of subcutaneous (SC) administration of TEV-48125 in adult participants with chronic migraine (CM) or episodic migraine (EM). Participants with CM or EM who complete the pivotal efficacy studies of TEV-48125 (TV48125-CNS-30049 \[NCT02621931\] and TV48125-CNS-30050 \[NCT02629861\]) and agree to participate in this study; and new participants meeting eligibility criteria (not rolling over from pivotal studies), will be enrolled in this study.

対象疾患

Migraine

介入

Fremanezumab(DRUG)
Placebo(DRUG)

依頼者(Sponsor)

実施施設 (13)

Teva Investigational Site 84063

Shinjuku-ku, Japan

Teva Investigational Site 84069

Kai, Japan

Teva Investigational Site 84070

Saitama, Japan

Teva Investigational Site 84064

Tokyo, Japan

Teva Investigational Site 84062

Osaka, Japan

Teva Investigational Site 84066

Kagoshima, Japan

Teva Investigational Site 84061

Sendai, Japan

Teva Investigational Site 84072

Chofu-shi, Japan

Teva Investigational Site 84067

Kyoto, Japan

Teva Investigational Site 84071

Toyonaka, Japan

Teva Investigational Site 84073

Kawasaki, Japan

Teva Investigational Site 84068

Shizuoka, Japan

Teva Investigational Site 84065

Tochigi, Japan