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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.

Tracking Information
First Submitted Date  ICMJE May 7, 2008
First Posted Date  ICMJE May 8, 2008
Last Update Posted Date December 11, 2008
Study Start Date  ICMJE April 2008
Estimated Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 21, 2008)
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. ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 7, 2008)
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 (week 8); Visit 3 (week 24); Phone Visit (week 36); Visit 4 (week 42) ]
Change History Complete list of historical versions of study NCT00675025 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 21, 2008)
Vinland II Adaptive Behavior Scale; Parent /Caregiver Rating Form. [ Time Frame: Visit 1 (baseline); Visit 4 (week 42). ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 7, 2008)
Vinland II Adaptive Behavior Scale; Parent /Caregiver Rating Form. [ Time Frame: Visit 1 (baseline); Visit 4 (week 42) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Down Syndrome
Intervention  ICMJE Drug: Donepezil Hydrochloride (Aricept)
Liquid form Aricept - 5 mg/5 mL donepezil hydrochloride.
Other Name: Aricept
Study Arms  ICMJE Experimental: 1
Intervention: Drug: Donepezil Hydrochloride (Aricept)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Estimated Enrollment  ICMJE
 (submitted: May 7, 2008)
128
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00675025
Other Study ID Numbers  ICMJE E2020-A001-220
A2501060
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yvonne Noble, Study Manager, Eisai Inc.
Study Sponsor  ICMJE Eisai Inc.
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Study Director: Anita Murthy, PharmD Eisai Inc.
PRS Account Eisai Inc.
Verification Date December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP