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筋痛性脳脊髄炎/慢性疲労症候群(ME/CFS)におけるリツキシマブの有効性と安全性に関する研究

基本情報

NCT ID
NCT06952413
ステータス
募集中
試験のフェーズ
第2相
試験タイプ
介入
目標被験者数
30
治験依頼者名
National Center of Neurology and Psychiatry, Japan

概要

The efficacy and safety of rituximab on ME/CFS symptoms after administration to patients with myalgic encephalomyelitis/chronic fatigue syndrome will be compared in an exploratory, placebo-controlled, double-blind fashion. In the subsequent secondary evaluation period, subjects who received rituximab in the primary evaluation period will receive placebo, and the timing and duration of rituximab's effect will be explored throughout the entire evaluation period. Subjects who received placebo during the primary evaluation period will receive rituximab during the secondary evaluation period to explore changes in endpoints before and after switching from placebo to rituximab in the same subjects.

対象疾患

Myalgia Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)

介入

Rituximab(Genetical Recombination)(DRUG)
Placebo(DRUG)

実施施設 (1)

国立研究開発法人国立精神・神経医療研究センター病院

Kodaira, Tokyo, Japan(RECRUITING)