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A Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study of Multiple Doses of BIIB014 Administered Orally in Subjects With Early Parkinson's Disease

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DataCite Commons2025-01-06 更新2026-05-07 收录
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https://search.vivli.org/doiLanding/studies/00007167/isLanding
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The main purpose of this study is to determine the safety of BIIB014 and how well BIIB014 is tolerated when given at different doses to patients with early-stage Parkinson's Disease. This study will also explore: - How BIIB014 is affected when given to patients with early-stage Parkinson's Disease (this will be done by measuring the levels of BIIB014 in the blood at several different times during the study), and - The activity of BIIB014 when given to early Parkinson's patients (this will be done by performing different Parkinson's Disease assessments and other tests during the study). Patients who enter this study will be randomly assigned to receive either BIIB014 or a placebo but because the study is blinded, neither they nor their study doctor will know which study treatment they are taking.

本研究的核心目的为评估BIIB014的安全性,以及不同给药剂量下,BIIB014在早期帕金森病(early-stage Parkinson's Disease)患者中的耐受性表现。 本研究同时将探索以下内容: - 早期帕金森病患者给药后BIIB014的体内暴露特征,该评估将通过在研究期间多个时间节点检测受试者血液中的BIIB014浓度完成; - BIIB014在早期帕金森病患者中的药理活性,该验证将通过在研究期间开展多项帕金森病评估及其他检测完成。 入组本研究的患者将被随机分配至BIIB014组或安慰剂(placebo)组;由于本研究采用盲法(blinded)设计,患者及其主治研究医师均无法知晓受试者实际接受的研究治疗方案。
提供机构:
Vivli
创建时间:
2021-06-10
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