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Trial record 79 of 331 for:    DONEPEZIL

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

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ClinicalTrials.gov Identifier: NCT00675025
Recruitment Status : Terminated (Sufficient evidence of efficacy not met. Discontinuation not based on any safety concerns.)
First Posted : May 8, 2008
Last Update Posted : December 11, 2008
Sponsor:
Collaborator:
Pfizer
Information provided by:
Eisai Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Down Syndrome Drug: Donepezil Hydrochloride (Aricept) Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : April 2008
Estimated Primary Completion Date : February 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Down Syndrome

Arm Intervention/treatment
Experimental: 1 Drug: Donepezil Hydrochloride (Aricept)
Liquid form Aricept - 5 mg/5 mL donepezil hydrochloride.
Other Name: Aricept




Primary Outcome Measures :
  1. 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. ]

Secondary Outcome Measures :
  1. Vinland II Adaptive Behavior Scale; Parent /Caregiver Rating Form. [ Time Frame: Visit 1 (baseline); Visit 4 (week 42). ]


Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00675025


  Show 31 Study Locations
Sponsors and Collaborators
Eisai Inc.
Pfizer
Investigators
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Study Director: Anita Murthy, PharmD Eisai Inc.

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Responsible Party: Yvonne Noble, Study Manager, Eisai Inc.
ClinicalTrials.gov Identifier: NCT00675025     History of Changes
Other Study ID Numbers: E2020-A001-220
A2501060
First Posted: May 8, 2008    Key Record Dates
Last Update Posted: December 11, 2008
Last Verified: December 2008
Additional relevant MeSH terms:
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Donepezil
Down Syndrome
Syndrome
Cognitive Dysfunction
Disease
Pathologic Processes
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents