Ropinirole hydrochloride remedy for amyotrophic lateral sclerosis - Protocol for a randomized, double-blind, placebo-controlled, single-center, and open-label continuation phase I/IIa clinical trial (ROPALS trial)

Regenerative Therapy
Satoru MorimotoJin Nakahara

Abstract

Amyotrophic lateral sclerosis (ALS) is an intractable and incurable neurological disease. It is a progressive disease characterized by muscle atrophy and weakness caused by selective vulnerability of upper and lower motor neurons. In disease research, it has been common to use mouse models carrying mutations in responsible genes for familial ALS as pathological models of ALS. However, there is no model that has reproduced the actual conditions of human spinal cord pathology. Thus, we developed a method of producing human spinal motor neurons using human induced pluripotent stem cells (iPSCs) and an innovative experimental technique for drug screening. As a result, ropinirole hydrochloride was eventually discovered after considering such results as its preferable transitivity in the brain and tolerability, including possible adverse reactions. Therefore, we explore the safety, tolerability and efficacy of ropinirole hydrochloride as an ALS treatment in this clinical trial. The ROPALS trial is a single-center double-blind randomized parallel group-controlled trial of the safety, tolerability, and efficacy of the ropinirole hydrochloride extended-release tablet (Requip CR) at 2- to 16-mg doses in patients with ALS. Twenty patients...Continue Reading

Citations

Aug 17, 2020·Current Opinion in Neurology·Ruben P A van EijkLeonard H van den Berg
Dec 19, 2019·International Journal of Molecular Sciences·María Del Carmen Ortuño-CostelaM Esther Gallardo
Nov 14, 2020·International Journal of Stroke : Official Journal of the International Stroke Society·Siobhan CrillyPaul R Kasher
Oct 31, 2020·Trends in Molecular Medicine·Svetlana Pasteuning-VuhmanR Jeroen Pasterkamp
Mar 2, 2021·Neural Regeneration Research·Yuri Matteo FalzoneNilo Riva
May 4, 2021·Frontiers in Cell and Developmental Biology·Marisa CappellaMaria Grazia Biferi
May 29, 2021·RSC Medicinal Chemistry·Matteo BorginiPeter Wipf
Oct 17, 2020·Molecular Neurodegeneration·Elisabetta ZucchiJessica Mandrioli
Sep 2, 2021·Annual Review of Biomedical Data Science·Jonathan Li, Ernest Fraenkel

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Methods Mentioned

BETA
RNA-seq
pregnancy test

Software Mentioned

Zarit
ALSAQ0
Requip

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