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

NCT00675025

Last updated date
Study Location
Phoenix Children's Hospital
Phoenix, Arizona, 85016, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Down Syndrome
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
10-17 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Down SyndromeEvaluating The Efficacy And Safety Of Donepezil Hydrochloride (Aricept) In Treating Cognitive Dysfunction Exhibited By Children With Down Syndrome
NCT00570128
  1. Phoenix, Arizona
  2. Little Rock, Arkansas
  3. Los Angeles, California
  4. Oakland, California
  5. Orange, California
  6. San Diego, California
  7. Lakewood, Colorado
  8. Fort Myers, Florida
  9. Miami, Florida
  10. Miami, Florida
  11. Miami, Florida
  12. St. Petersburg, Florida
  13. West Palm Beach, Florida
  14. Atlanta, Georgia
  15. Zionsville, Indiana
  16. Flint, Michigan
  17. Grand Rapids, Michigan
  18. Saint Paul, Minnesota
  19. Saint Louis, Missouri
  20. Lincoln, Nebraska
  21. Voorhees, New Jersey
  22. Durham, North Carolina
  23. Cleveland, Ohio
  24. Toledo, Ohio
  25. Tulsa, Oklahoma
  26. Charleston, South Carolina
  27. Nashville, Tennessee
  28. Houston, Texas
  29. San Antonio, Texas
  30. San Antonio, Texas
  31. Bellevue, Washington
ALL GENDERS
10 Years+
years
MULTIPLE SITES
Down SyndromeEvaluating 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
NCT00675025
  1. Phoenix, Arizona
  2. Little Rock, Arkansas
  3. Los Angeles, California
  4. Oakland, California
  5. Orange, California
  6. San Diego, California
  7. Lakewood, Colorado
  8. Fort Myers, Florida
  9. Miami, Florida
  10. Miami, Florida
  11. Miami, Florida
  12. St. Petersburg, Florida
  13. West Palm Beach, Florida
  14. Atlanta, Georgia
  15. Flint, Michigan
  16. Grand Rapids, Michigan
  17. Grand Rapids, Michigan
  18. Saint Paul, Minnesota
  19. Saint Louis, Missouri
  20. Lincoln, Nebraska
  21. Voorhees, New Jersey
  22. Durham, North Carolina
  23. Cleveland, Ohio
  24. Toledo, Ohio
  25. Tulsa, Oklahoma
  26. Charleston, South Carolina
  27. Nashville, Tennessee
  28. Houston, Texas
  29. San Antonio, Texas
  30. San Antonio, Texas
  31. Bellevue, Washington
ALL GENDERS
10 Years+
years
MULTIPLE SITES
Advanced Information
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, PharmDEisai 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