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NCT00754013 · ClinicalTrials.gov registry record · Phase 3
Evaluating The Efficacy And Safety Of Donepezil Hydrochloride (Aricept) In The Treatment Of The Cognitive Dysfunction Exhibited By Children With Down Syndrome, Aged 6 To 10
A Phase 3 study, sponsored by Eisai.
- Terminated
- Registry status
- Phase 3
- Development phase
- 9
- Enrollment target
NCT00754013: Clinical Trial Phase 3 study, sponsored by Eisai.
NCT00754013 is a Phase 3 study that was terminated before completion, run by Eisai. The registered enrollment target is 9 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00754013, a Phase 3 study, was terminated before completion, sponsored by Eisai.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 9 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the efficacy and safety of donepezil hydrochloride (Aricept) in the treatment of cognitive dysfunction shown by children with Down syndrome, aged 6 to 10 years.
Primary Outcome
The primary objective of the study was evaluation of the efficacy and safety of donepezil hydrochloride in the treatment of the cognitive dysfunction exhibited by children with Down syndrome (DS), aged 6 to 10, as assessed by analysis of VABS-II/PCRF in the domains of communication, daily living skills, and socialization, and as assessed by standard safety measurements.
Interventions
- DRUG Placebo
- DRUG Aricept (Donepezil hydrochloride)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2008-09 |
| Est. Completion | 2008-12 |
| Phase | Phase 3 |
Why NCT00754013 stopped before completion
NCT00754013 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00754013 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00754013 about?
NCT00754013 is a clinical study titled "Evaluating The Efficacy And Safety Of Donepezil Hydrochloride (Aricept) In The Treatment Of The Cognitive Dysfunction Exhibited By Children With Down Syndrome, Aged 6 To 10". The purpose of this study is to determine the efficacy and safety of donepezil hydrochloride (Aricept) in the treatment of cognitive dysfunction shown by children with Down syndrome, aged 6 to 10 years.
What is the current status of trial NCT00754013?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 9 participants. The study started on 2008-09. Estimated completion is 2008-12.
What interventions are being tested in trial NCT00754013?
The interventions under investigation include: Placebo (DRUG), Aricept (Donepezil hydrochloride) (DRUG).
Who is sponsoring clinical trial NCT00754013?
This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00754013's enrollment target sits among peer trials
9 1992nd of 2000 higher than 8 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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