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

JRCT ID: jRCT2041230001

Registered date:03/04/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Achondroplasia
• Date of first enrollment: 15/05/2023
• Target sample size: 9
• Study type: Interventional
• Intervention(s): Administered MECLIZIN oraly once a daily for 26 weeks.

Outcome(s)

Primary Outcome

Safety: Safety data for 7 months from the first treatment
Efficacy: Growth rate

Key inclusion & exclusion criteria

• Age minimum: >= 5age old
• Age maximum: < 11age old
• Gender: Both

Include criteria

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

Exclude criteria

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.

Related Information

• Primary Sponsor: Matsushita Masaki