NL-OMON52899
Completed
Phase 4
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 (CARE study)
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Centre for Human Drug Research
- Enrollment
- 40
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Part A, correlation blood\-saliva PK.
- •\* Healthy male or female volunteers aged 18\-30 years
- •\* 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
Exclusion Criteria
- •Part A, healthy volunteers
- •\* 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
Outcomes
Primary Outcomes
Not specified
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