Masahide YAZAKI, MD, PhD
Institute for Biomedical Sciences, Shinshu University

Evaluation of therapeutic efficacy and safety of oral intake of LOLA (L-ornithine, L-aspartate) for CTLN2 patients: A non-double blind pilot study

A continuation of the clinical research study to seek for a new treatment method for CTLN2 led by Prof. Yazaki in Shinshu University in Japan. Citrin Foundation funds this clinical research.

This clinical research (*1) aims to study the efficacy and safety of oral administration of LOLA (L-Ornithine L-Aspartate) on CTLN2 patients and investigate the possibility of a new choice of treatment for CTLN2.

*1: Clinical Research is a medical study to be carried out with the purpose to seek for prevention of the onset, diagnosis method, improvement of treatment, understanding of the cause of sickness, and improvement in the quality of life of the patients.

Period:

Apr 1, 2019 to Sept 3, 2023

Method:

Oral administration of LOLA 3 to 6g 3 times a day after meal.

Flow:

In the beginning of the study, ten-day in-patient is required for the monitoring of the 1st LOLA administration. After 3 months of observation followed by the 1st in-patient, another 3-day in-patient is required. Oral administration of LOLA is to be continued for the total 6 months and there will be 4 out-patient visits during the period.

Fee:

This clinical research is supported by the study grant by Citrin Foundation.
Fee related to LOLA prescription, examination, in-patient fee including meals, and transportation from/to the hospital for the purpose of this study will be covered by the grant and there will be no financial burden on the participants.
LOLA will be provided to participants for 3 years after the study with free of charge if they wish.

Institutions:

Shinshu University Hospital
Osaka City University Hospital

Principle Investigator:

Dr. Masahide Yazaki, Shinshu University Hospital

Collaborating Principle Investigator:

Dr. Daisuke Tokuhara, Osaka City University Hospital

(Updated August 2022)