計劃書編號YA-101-201
尚未開始召募
2025-01-01 - 2026-12-31
Phase II
召募中2
ICD-10G23.0
Hallervorden-Spatz氏病
ICD-10G23.1
進行性核上麻痺 [Steele-Richardson-Olszewski氏病]
ICD-10G23.2
紋狀體黑質退化
ICD-10G23.8
其他特定之基底核退化性疾病
ICD-10G23.9
基底核退化性疾病
ICD-10G90.3
自主神經系統多重系統退化
ICD-9333.0
基底神經節之其他退化性疾病
YA-101 對於多重系統退化症受試者中的安全性、耐受性、藥物動力學和療效研究：一雙盲、安慰劑對照、多中心、劑量遞增的臨床二期試驗
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試驗委託 / 贊助單位名稱
思捷優達股份有限公司
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臨床試驗規模
多國多中心
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更新日期
2026/02/01
試驗主持人及試驗醫院
實際收案人數
0 召募中
實際收案人數
0 召募中
適應症
多重系統退化症
試驗目的
NA
藥品名稱
N/A
主成份
NA
劑型
N/A
劑量
NA
評估指標
不良事件反應
主要納入條件
1.Able to understand the process of the clinical trial and give informed consent for the participation of the study.
2.Diagnosis of MSA according to MDS clinical criteria (Wenning et al, 2022), including subjects with MSA of either subtype (MSA-P or MSA-C).
3.Males or non-pregnant, non-lactating females with no child-bearing potential, or agree to use 2 forms of contraception.
4.Able to take oral medications.
5.Able to ambulate without the assistance of another person.
2.Diagnosis of MSA according to MDS clinical criteria (Wenning et al, 2022), including subjects with MSA of either subtype (MSA-P or MSA-C).
3.Males or non-pregnant, non-lactating females with no child-bearing potential, or agree to use 2 forms of contraception.
4.Able to take oral medications.
5.Able to ambulate without the assistance of another person.
主要排除條件
1.Positive urine test for drugs of abuse and/or alcohol test both at screening and Day 1.
2.Evidence of renal impairment or hepatic impairment.
3.Subject with a Mini-Mental State Examination (MMSE) score of 24 or lower.
4.Medical history includes severe systemic diseases such as cardiopulmonary failure, severe liver or kidney disease, and uncontrolled diabetes; significant 5.central nervous system disorders like stroke, encephalitis, and epilepsy and severe head trauma; peptic ulcer in one year prior to screening.
6.Positive results for active viral infections, including human immunodeficiency virus (HIV), hepatitis B, and hepatitis C.
2.Evidence of renal impairment or hepatic impairment.
3.Subject with a Mini-Mental State Examination (MMSE) score of 24 or lower.
4.Medical history includes severe systemic diseases such as cardiopulmonary failure, severe liver or kidney disease, and uncontrolled diabetes; significant 5.central nervous system disorders like stroke, encephalitis, and epilepsy and severe head trauma; peptic ulcer in one year prior to screening.
6.Positive results for active viral infections, including human immunodeficiency virus (HIV), hepatitis B, and hepatitis C.
試驗計畫預計收納受試者人數
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台灣人數
30 人
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全球人數
75 人
