Evaluating The Safety Of Donepezil Hydrochloride (Aricept) For Up To 1 Year In The Treatment Of The Cognitive Dysfunction Exhibited By Children With Down Syndrome - Follow-Up To A 10-Week, Double-Blind, Placebo-Controlled Trial
- Conditions
- Down Syndrome, Cognitive DysfunctionTherapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
- Registration Number
- EUCTR2016-004947-35-Outside-EU/EEA
- Lead Sponsor
- Eisai Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 117
•Diagnosis of Down syndrome (established during study E2020-A001-220).
•Completion of study E2020-A001-219 (NCT00570128 [also known as A2501059]) with no ongoing serious adverse events and no severe drug reactions.
Are the trial subjects under 18? yes
Number of subjects for this age range: 117
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 117
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
•Weight less than 20 kilogram (kg).
•Clinically significant conditions affecting absorption, distribution or metabolism of the study medication.
•No reliable parent or caregiver, or unwillingness or inability of parent or caregiver to fulfill the requirements of the study.
•Females of childbearing potential who are not practicing an effective means of birth control.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method