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

This study has been terminated.

( Sufficient evidence of efficacy not met. Discontinuation not based on any safety concerns. )

First Received on May 7, 2008. Last Updated on December 10, 2008 History of Changes

Sponsor:	Eisai Inc.
Collaborator:	Pfizer
Information provided by:	Eisai Inc.
ClinicalTrials.gov Identifier:	NCT00675025

Purpose

The purpose of this study is to determine the safety of donepezil hydrochloride (Aricept) in children with Down syndrome who have finished the preceding 10-week, double-blind study of donepezil hydrochloride. Medical tests for drug safety will be conducted at each clinic visit.

Condition	Intervention	Phase
Down Syndrome	Drug: Donepezil Hydrochloride (Aricept)	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	An Open-Label Study To Evaluate 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

Resource links provided by NLM:

Genetics Home Reference related topics: 17q21.31 microdeletion syndrome Down syndrome tetrasomy 18p

MedlinePlus related topics: Down Syndrome

Drug Information available for: E 2020 Donepezil

U.S. FDA Resources

Further study details as provided by Eisai Inc.:

Primary Outcome Measures:

Physical and neurological exams, clinical labs, ECG, Conmeds, Adverse Events, Serious Adverse Events. [ Time Frame: Visit 1 (baseline); Phone Visit (weeks 2,4,6); Visit 2. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Vinland II Adaptive Behavior Scale; Parent /Caregiver Rating Form. [ Time Frame: Visit 1 (baseline); Visit 4 (week 42). ] [ Designated as safety issue: No ]

Estimated Enrollment:	128
Study Start Date:	April 2008
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: Donepezil Hydrochloride (Aricept) Liquid form Aricept - 5 mg/5 mL donepezil hydrochloride. Other Name: Aricept

Detailed Description:

All children in this study will take donepezil hydrochloride once a day, and will come back to the clinic at 8, 24 and 42 weeks after the study has begun. In between these clinic visits, the clinical staff will telephone the child's parent or caregiver to discuss drug safety observations and possible changes in drug dose. At the end of the study (42 weeks), psychological testing will also be given to determine how well the child is functioning.

Eligibility

Ages Eligible for Study:	10 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of Down syndrome (established during study E2020-A001-220).
Completion of study E2020-A001-219 (also known as A2501059) with no ongoing SAEs and no severe drug reactions.

Exclusion Criteria:

Weight less than 20 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00675025

Show 31 Study Locations

Sponsors and Collaborators

Eisai Inc.

Pfizer

Investigators

Study Director:

Anita Murthy, PharmD

Eisai Inc.

More Information

No publications provided

Responsible Party:	Yvonne Noble, Study Manager, Eisai Inc.
ClinicalTrials.gov Identifier:	NCT00675025 History of Changes
Other Study ID Numbers:	E2020-A001-220, A2501060
Study First Received:	May 7, 2008
Last Updated:	December 10, 2008
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Down Syndrome
Cognition Disorders
Mental Retardation
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

Donepezil
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012