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Evaluating The Efficacy And Safety Of Donepezil Hydrochloride (Aricept) In The Treatment Of The Cognitive Dysfunction Exhibited By Children With Down Syndrome, Aged 11 To 17

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ClinicalTrials.gov Identifier: NCT00754052
Recruitment Status : Terminated (Sufficient evidence of efficacy not met. Discontinuation not based on any safety concerns.)
First Posted : September 17, 2008
Results First Posted : April 23, 2018
Last Update Posted : April 23, 2018
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Eisai Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Down Syndrome
Cognitive Dysfunction
Interventions Drug: Aricept (donepezil hydrochloride)
Drug: Placebo
Enrollment 8
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Donepezil Hydrochloride Placebo
Hide Arm/Group Description Blinded oral donepezil hydrochloride, was started at 2.5 mL daily, followed by 2-week titration intervals over a period of 6 weeks until a maximum dose of 5 milligrams per kilograms per day (mg/kg/day) or 10 mg/kg/day was reached. Due to early termination of the study no participant reached either targeted maximum. Participants received matching placebo in a 1:1:1 ratio.
Period Title: Overall Study
Started 5 3
Completed 0 0
Not Completed 5 3
Reason Not Completed
Study terminated by Sponsor             5             3
Arm/Group Title Donepezil Hydrochloride Placebo Total
Hide Arm/Group Description Blinded oral donepezil hydrochloride, was started at 2.5 mL daily, followed by 2-week titration intervals over a period of 6 weeks until a maximum dose of 5 mg/kg/day or 10 mg/kg/day was reached. Due to early termination of the study no participant reached either targeted maximum. Participants received matching placebo in a 1:1:1 ratio. Total of all reporting groups
Overall Number of Baseline Participants 5 3 8
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 5 participants 3 participants 8 participants
12.8
(11 to 16)
15.0
(13 to 17)
13.6
(11 to 17)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 3 participants 8 participants
Female
1
  20.0%
1
  33.3%
2
  25.0%
Male
4
  80.0%
2
  66.7%
6
  75.0%
1.Primary Outcome
Title Mean Change From Baseline in Vineland-II Adaptive Behavior Scale (VABS-II) Parent/Caregiver Rating Form (PCRF) Score Using Last Observation Carried Forward (LOCF)
Hide Description Mean change from Baseline from Visit 1 (baseline) to Visit 3 (Week 10 or early termination) in VABS-11/PCRF, a sum of the 9 sub-domain v-scores (3 scores for each of the communication, daily living skills, and socialization domains) using last observation carried forward was planned.
Time Frame Baseline (Day 0) to Visit 3 (Week 10) or at early termination
Hide Outcome Measure Data
Hide Analysis Population Description
Because the study was terminated early, only 8 subjects were enrolled. Analyses were not performed due to study medication exposure being limited and variable, limited efficacy data were collected, and no participant reached their maximum targeted dose.
Arm/Group Title Donepezil Hydrochloride Placebo
Hide Arm/Group Description:
Blinded oral donepezil hydrochloride, was started at 2.5 mL daily, followed by 2-week titration intervals over a period of 6 weeks until a maximum dose of 5 mg/kg/day or 10 mg/kg/day was reached. Due to early termination of the study no participant reached either targeted maximum.
Participants received matching placebo in a 1:1:1 ratio.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Mean Change From Baseline in Additional Analyses of the VABS-11/PCRF
Hide Description Additional analyses of the VABS-II/PCRF were planned.
Time Frame Baseline (Day 0) to Visit 3 (Week 10) or early termination
Hide Outcome Measure Data
Hide Analysis Population Description
Because the study was terminated early, only 8 subjects were enrolled. Analyses were not performed due to study medication exposure being limited and variable, limited efficacy data were collected, and no participant reached their maximum targeted dose.
Arm/Group Title Donepezil Hydrochloride Placebo
Hide Arm/Group Description:
Blinded oral donepezil hydrochloride, was started at 2.5 mL daily, followed by 2-week titration intervals over a period of 6 weeks until a maximum dose of 5 mg/kg/day or 10 mg/kg/day was reached. Due to early termination of the study no participant reached either targeted maximum.
Participants received matching placebo in a 1:1:1 ratio.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Mean Change From Baseline in Test of Verbal Expression and Reasoning (TOVER)
Hide Description TOVER, a subject performance-based measure of expressive language function was planned.
Time Frame Baseline (Day 0) to Visit 3 (Week 10) or early termination
Hide Outcome Measure Data
Hide Analysis Population Description
Because the study was terminated early, only 8 subjects were enrolled. Analyses were not performed due to study medication exposure being limited and variable, limited efficacy data were collected, and no participant reached their maximum targeted dose.
Arm/Group Title Donepezil Hydrochloride Placebo
Hide Arm/Group Description:
Blinded oral donepezil hydrochloride, was started at 2.5 mL daily, followed by 2-week titration intervals over a period of 6 weeks until a maximum dose of 5 mg/kg/day or 10 mg/kg/day was reached. Due to early termination of the study no participant reached either targeted maximum.
Participants received matching placebo in a 1:1:1 ratio.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Mean Change From Baseline if the Forward Memory and Attention Sustained Sub-tests of the Leiter International Performance Scale - Revised (Leiter-R)
Hide Description Forward Memory and Attention Sustained sub-tests of the Leiter International Performance Scale - Revised (Leiter-R), a cognitive assessment instrument for children and adolescents that is not language dependent was planned.
Time Frame Baseline (Day 0) to Visit 3 (Week 10) or early termination
Hide Outcome Measure Data
Hide Analysis Population Description
Because the study was terminated early, only 8 subjects were enrolled. Analyses were not performed due to study medication exposure being limited and variable, limited efficacy data were collected, and no participant reached their maximum targeted dose.
Arm/Group Title Donepezil Hydrochloride Placebo
Hide Arm/Group Description:
Blinded oral donepezil hydrochloride, was started at 2.5 mL daily, followed by 2-week titration intervals over a period of 6 weeks until a maximum dose of 5 mg/kg/day or 10 mg/kg/day was reached. Due to early termination of the study no participant reached either targeted maximum.
Participants received matching placebo in a 1:1:1 ratio.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Adverse events (AEs) and treatment emergent AEs (TEAEs) were collected from the time of screening (prior to start of study medication) until termination of the study.
Adverse Event Reporting Description The Safety Population included all 8 participants who received at least 1 dose of study medication.
 
Arm/Group Title Donepezil Hydrochloride Placebo
Hide Arm/Group Description Blinded oral donepezil hydrochloride, was started at 2.5 mL daily, followed by 2-week titration intervals over a period of 6 weeks until a maximum dose of 5 mg/kg/day or 10 mg/kg/day was reached. Due to early termination of the study no participant reached either targeted maximum. Participants received matching placebo in a 1:1:1 ratio.
All-Cause Mortality
Donepezil Hydrochloride Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)   0/3 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Donepezil Hydrochloride Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)   0/3 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Donepezil Hydrochloride Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   2/5 (40.00%)   1/3 (33.33%) 
Gastrointestinal disorders     
Nausea  1  1/5 (20.00%)  1/3 (33.33%) 
General disorders     
Diarrhea  1  1/5 (20.00%)  1/3 (33.33%) 
Infections and infestations     
Ear infection  1  1/5 (20.00%)  0/3 (0.00%) 
1
Term from vocabulary, MedDRA (11.1)
Indicates events were collected by systematic assessment
This was a 10-week double blind placebo-controlled trial that was terminated early due to the results of a similarly-designed study showing it would be futile to continue this study.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Eisai Medical Services
Organization: Eisai Inc.
Phone: 1-888-422-4743
Layout table for additonal information
Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT00754052     History of Changes
Other Study ID Numbers: E2020-A001-335
A2501061
First Submitted: September 15, 2008
First Posted: September 17, 2008
Results First Submitted: March 23, 2018
Results First Posted: April 23, 2018
Last Update Posted: April 23, 2018