A Phase IIA trial in amyotrophic lateral sclerosis of the safety and biological efficacy (increase in regulatory T cells) of narrow-band UVB phototherapy plus standard-of-care compared to standard-of-care only.

Western Sydney Local Health District0 个研究点目标入组 20 人开始时间: 2015年8月3日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•1. Possible, probable or definite sporadic or familial ALS using the Awaji criteria (de Carvahlo et al, 2008, Clin neurophysiol, 119: 497-503).
•2. Amyotrophic Lateral Sclerosis Functional Rating Scale Revised (ALSFRS-R) of greater than or equal to 38.
•3. Ability to comply with all study procedures including standing in the treatment cubicle, attending 36 phototherapy visits, blood collection, and clinical assessments.

•1. ALS symptoms, other cardiovascular/ respiratory disease or any condition that prevents standing in the enclosed treatment cubicle for up to 10 min.
•2. Any immunological conditions including autoimmunity or other inflammatory conditions, or immunosuppressive or immunomodulatory medication that may independently influence regulatory T cell numbers.
•3. Pregnancy or planning to become pregnant, as this alters regulatory T cell numbers.

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