Randomized, double-blind, placebo-controlled, two way crossover, single centre study evaluating the acute and chronic effect of clonazepam on cognitive tests and patient-reported outcome measures in patients with ARID1B-related intellectual disability

Centre for Human Drug Research0 sites36 target enrollmentSeptember 7, 2022

Overview

2022 Results article in https://pubmed.ncbi.nlm.nih.gov/34811788/ (added 30/01/2023)

Registry

who.int

Start Date

September 7, 2022

End Date

June 3, 2022

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

•Part A: healthy volunteers
•1\. Healthy male or female volunteers aged 18\-30 years.
•2\. Informed consent provided by volunteer.
•Part B: ARID1B patients.
•1\. Informed consent provided by both parents, or the legal guardian prior to any study mandated procedure.
•2\. Known mutation in ARID1B.
•3\. Assent provided by the participant.
•4\. Aged 6 years or older.

•Part A: healthy volunteers
•1\. Disorder that could interfere with saliva production.
•2\. Known hypersensitivity to clonazepam, other benzodiazepines or other excipients of the study medication.
•3\. Treatment with another investigational drug within 3 months prior to screening or more than 4 times a year.
•4\. History or clinical evidence of any disease and/or existence of a surgical or medical condition which might interfere with the absorption, distribution, metabolism or excretion of the study drug.
•5\. History of severe respiratory problems or severe liver\- or renal insufficiency.
•6\. Other medical or psychosocial condition or history making the participant unsuitable for participation.
•7\. History or clinical evidence of alcoholism within the 3\-year period prior to screening (i.e. regular use of more than 21 units of alcohol/week).
•8\. Clinically significant findings on physical examination.
•9\. Medications with a strong influence on CYP3A4 metabolism.