An exploratory clinical trial to Investigate the efficacy and safety of Meclizine hydrochloride in Achondroplasia patients (pediatrics). - MACH trial

Matsushita Masaki0 sites9 target enrollmentApril 3, 2023

Overview

No summary available.

Registry

who.int

Start Date

April 3, 2023

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Matsushita Masaki

•1\) Patients who have been confirmed to Definite or Probable among the achondroplasia diagnostic criteria created by the Intractable Diseases Research Group of the Ministry of Health, Labor and Welfare more than one year before obtaining consent.
•2\) Patients whose age at the time of obtaining consent is 5 to 11 years old.
•3\)Patients with documented height data between 12 and 3 months prior to enrollment

•1\) Patients who started treatment with a growth hormone preparation within 1\.5 years (78 weeks) before obtaining informed consent
•2\) Patients who have been treated with drugs (CNP analogues, statins, etc.) for which basic or clinical data have been reported to suppress FGFR3 signals within 1 year before obtaining informed consent
•3\) Patients who have taken medicines such as motion sickness medicines containing meclizine hydrochloride continuously for more than 2 weeks within 1 year before obtaining informed consent, expecting bone lengthening effects.
•4\) Patients who have undergone bone lengthening surgery within 1 year or patients who are planning to perform bone lengthening surgery during the study drug administration period
•5\)Pregnant, lactating, or potentially pregnant female patients, or both male and female patients who cannot agree to use contraception during the study period under the guidance of the princepal investigator or subinvestigator.