脳卒中後の痙縮治療のための新世代ボツリヌス毒素A2NTXの研究

基本情報

NCT ID: NCT01910363
ステータス: 不明
試験のフェーズ: 第2/第3相
試験タイプ: 介入
目標被験者数: 30
治験依頼者名: University of Tokushima

概要

To test the safety and efficacy of a new generation botulinum toxin preparation A2NTX for treating stroke patients with lower limb spasticity. * we study the degree of spasticity in the ankle and knee joints, and walking speed in 30 patients with stroke before and after injecting 300 units of BOTOX or A2NTX in a blinded manner as for the patient, the physician, and the examiner. * we also assess the safety of A2NTX and compare it to that of BOTOX.

対象疾患

Lower Limb Spasticity After Stroke

介入

A2NTX(DRUG)

BOTOX(DRUG)

依頼者（Sponsor）

Ministry Of Health, Labour And Welfare, Japan(OTHER_GOV)

University Of Tokushima(OTHER)

実施施設 (1)

徳島大学病院

Tokushima, Tokushima, Japan