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. - Clonazepam in ARID1B Evaluation

Centre for Human Drug Research0 sites40 target enrollmentJanuary 8, 2020

Overview

No summary available.

Registry

who.int

Start Date

January 8, 2020

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Part A, saliva PK.
•Healthy male or female volunteers
•Informed consent provided by volunteer
•Part B, ARID1B patients.
•Informed consent provided by both parents, or the legal guardian prior to any study mandated procedure.
•Known mutation in ARID1B
•Assent provided by the participant.
•Aged 6 years or older
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 20

•Disorder that could interfere with saliva production.
•Known hypersensitivity to clonazepam, other benzodiazepines or other excipients of the study medication.
•Treatment with another investigational drug within 3 months prior to screening or more than 4 times a year.
•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.
•History of severe respiratory problems or severe liver\- or renal insufficiency.
•Other medical or psychosocial history making the participant unsuitable for participation as determined by the treating paediatrician.
•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).
•Clinically significant findings on physical examination.
•Medications with a strong influence on CYP3A4 metabolism
•Subjects with a BMI \> 30 and/or cardiovascular, respiratory or immune system disorders