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TEV-56286が多系統萎縮症患者の治療に有効かどうかを検証する試験

基本情報

NCT ID
NCT06568237
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
350
治験依頼者名
Teva Branded Pharmaceutical Products R&D, Inc.

概要

The primary objective of the study is to evaluate the efficacy of TEV-56286 administered orally for the treatment of adult participants with Multiple System Atrophy (MSA). A secondary objective of the study is to evaluate specific efficacy parameters of TEV-56286. Another secondary objective is to evaluate the safety and tolerability of TEV-56286. The planned study period per participant is 56 weeks including a screening period (up to 4 weeks), a 48-week double-blind treatment period, and a follow-up visit (approximately 4 weeks after the end of the double-blind treatment period). The study duration will be approximately 27 months.

対象疾患

多系統萎縮症

介入

TEV-56286(DRUG)
Placebo(DRUG)

依頼者(Sponsor)

実施施設 (9)

新潟大学医歯学総合病院

Niigata, Japan(RECRUITING)

独立行政法人 国立病院機構 仙台西多賀病院

Sendai, Japan(RECRUITING)

独立行政法人国立病院機構相模原病院

Sagamihara, Japan(RECRUITING)

Teva Investigational Site 84136

Gifu, Japan(RECRUITING)

Teva Investigational Site 84136

Gifu, Japan(RECRUITING)

Teva Investigational Site 84139

Fuchū, Japan(RECRUITING)

独立行政法人国立病院機構兵庫中央病院

Sanda-shi, Japan(RECRUITING)

Teva Investigational Site 84139

Fuchū, Japan(RECRUITING)

千葉大学医学部附属病院

Chiba, Japan(RECRUITING)