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Donepezil in children with Down Syndrome
NCT00754052Phase 3
Key facts
- Status
- Terminated
- Start
- Sep 2008
- Primary completion
- Nov 2008
- Countries
- 1
- Sponsor
- Eisai Co., Ltd.
- Modality
- Small Molecules
- Drugs
- donepezil
- Conditions
- cognitive dysfunction
01
Overview
Phase 3, randomised, double-blind trial of donepezil in cognitive dysfunction (3 arms), sponsored by Eisai Co., Ltd. Primary endpoint: Vineland-II Adaptive Behavior Scale Parent/Caregiver Rating Form at 10 weeks. Started Sep 2008; status: terminated.
02
Design
3 arms- Study design
- RandomizedDouble-blind
Donepezil 5 mg
Donepezil 2.5 mg/day escalated to 5 mg/day
Donepezil 10 mg
Donepezil 2.5 mg/day escalated to 10 mg/day
Placebo
Placebo matching donepezil
03
Who it enrols
Children aged 11-17 with Down syndrome and specific VABS-II scores, excluding those with major depressive disorder or unstable medical conditions.
04
Endpoints
Primary
Vineland-II Adaptive Behavior Scale Parent/Caregiver Rating Form
Secondary
Additional Analyses of the VABS-II/PCRF
Test of Verbal Expression and Reasoning
Leiter International Performance Scale - Revised
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