Clonazepam in patients with ARID1B-related intellectual disability

Phase 4

Completed

• Conditions: ARID1B-related intellectual disability; Mental and Behavioural Disorders

• Registration Number: ISRCTN11225608
• Lead Sponsor: Centre for Human Drug Research

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-06-03
• Study Start: 2022-09-07
• Last Update Posted: 26 September 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

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.

Exclusion Criteria

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.
10. Clinically meaningful blood loss (including blood donation), or a transfusion of any blood product within 12 weeks before screening.

Part B: ARID1B patients.
1. Clear indication of not wanting to participate during the study.
2. Use of benzodiazepines or any other medication or drug with the potential to influence study related endpoints in the investigator’s opinion (including e.g. CYP3A4-related drugs).
3. Known hypersensitivity to clonazepam, other benzodiazepines or other excipients of the study medication.
4. History of severe respiratory problems or severe liver- or renal insufficiency.
5. Other medical or psychosocial condition or history making the participant unsuitable for participation as determined by the treating physician or general practitioner.

Study & Design

• Study Type: Interventional
• Study Design: Not specified