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| ID | Type | Description | Link |
|---|---|---|---|
| A2501060 | Other Identifier | Pfizer |
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Sufficient evidence of efficacy not met. Discontinuation not based on any safety concerns.
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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prior Donepezil-DB | Experimental | All participants started with a dose of 2.5 mg/day (2.5 mL/day). Dose escalations occurred in 2.5 mg/day increments every 2 weeks (steady state levels assumed to have been reached) to a maximum dose of 10 mg/day, according to the participant's weight schedule and the Investigator's judgment of safety and tolerability. Re-titration was done to maintain the blinding of the double-blind study (E2020-A001-219). Doses could be decreased due to tolerability and could be increased or decreased to maintain a maximum dose of 0.1 to 0.2 mg/kg/day based on the participant's weight at clinic visits during the study duration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Donepezil hydrochloride (Aricept) | Drug | Liquid form Aricept - 5 mg/5 mL donepezil hydrochloride. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Visit 1 (Baseline) to Visit 4 or Early Termination in the Vineland Adaptive Behavior Scales, 2nd Edition, Parent/Caregiver Rating Form (VABS-II/PCRF) Sum of the 9 Sub-domain V-scores | VABS-II/PCRF assessed participant's adaptive behaviors on 3 domains (each has 3 sub-domains): Communication (receptive, expressive, written), Daily Living Skills (personal, domestic, community), Socialization (interpersonal relationships, play a leisure time, coping skills). Parent/caregiver rated participant's behavior for sub-domains from 0 (never present) to 2 (always present). Raw scores from sub-domains converted into standardized score(V-scale scores) ranged:1-24 for each sub-domain, mean=15,standard deviation(SD)=3,higher scores=higher level of adaptive functioning and were summed to obtain V-scale composite score ranged 9-216, mean=100,SD=15,higher scores=higher level of adaptive functioning, positive change=improvement in adaptive functioning. Composite and individual analyses, both raw and standardized scores, were not performed due to lack of significant differences between donepezil and placebo in parent study. | Visit 1 (baseline); Early Termination Visit (Week 36) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix Children's Hospital | Phoenix | Arizona | 85016 | United States | ||
| Child Neurology Associates, PC |
The Screening and baseline activities for this study took place on the same day as the Week 10 final visit of the double-blind (DB) study (2020-A001-219 [NCT00570128]).
This study was recruited at 24 centers in the United States during the period of 4 Apr 2008 to 15 Dec 2008. All participants who completed the double-blind (DB) placebo-controlled, 10 week study (Study 2020-A001-219 [NCT00570128]) were offered enrollment in this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Prior Donepezil-DB | Participants who received donepezil in the double-blind study E2020-A001-219 (NCT00570128) were continued in this open label extension (OLE) study to be treated with donepezil titrated to achieve a final dose of 0.1 - 0.2 milligram per kilogram per day (mg/kg/day) using liquid formulated at 5 mg/5 milliliter (mL) for up to approximately Week 42. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Little Rock |
| Arkansas |
| 72205 |
| United States |
| Midwest Children's Health Research Institute | Los Angeles | California | 90048 | United States |
| Children's Hospital and Research Center at Oakland | Oakland | California | 94609 | United States |
| University of California, Irvine Medical Center | Orange | California | 92868 | United States |
| UCSD Pediatric Pharmacology Research Unit | San Diego | California | 92123 | United States |
| Rocky Mountain Pediatrics, P.C. | Lakewood | Colorado | 80214 | United States |
| Neufeld Medical Group, Inc. | Fort Myers | Florida | 33912 | United States |
| Miami Children's Hospital | Miami | Florida | 33155-3009 | United States |
| Miami Children's Hospital - Medical Genetics and Neuro-Developmental Center | Miami | Florida | 33155 | United States |
| Phoenix Children's Hospital | Miami | Florida | 33155 | United States |
| Clinical Studies Centers, LLC | St. Petersburg | Florida | 33709 | United States |
| Northwest Clinical Research Center | West Palm Beach | Florida | 33407 | United States |
| Road Runner Research | Atlanta | Georgia | 30342 | United States |
| Hurley Medical Center | Flint | Michigan | 48503 | United States |
| Saint Mary's Health Care | Grand Rapids | Michigan | 49503 | United States |
| Washington University School of Medicine | Grand Rapids | Michigan | 49503 | United States |
| Regions Hospital | Saint Paul | Minnesota | 55101-2595 | United States |
| Northwest Clinical Research Center | St Louis | Missouri | 63110 | United States |
| Meridien Research | Lincoln | Nebraska | 68504 | United States |
| Clinical Research Center of New Jersey | Voorhees Township | New Jersey | 08043 | United States |
| Division of Genetics and Developmental Behavior | Durham | North Carolina | 27710 | United States |
| Metrohealth Medical Center | Cleveland | Ohio | 44109 | United States |
| Valko and Associates | Toledo | Ohio | 43606 | United States |
| Office of Lazlo Mate | Tulsa | Oklahoma | 74104 | United States |
| Medical Univ of South Carolina | Charleston | South Carolina | 29425 | United States |
| Vanderbilt Children's Hospital | Nashville | Tennessee | 37232-9225 | United States |
| Down Syndrome Clinic of Houston | Houston | Texas | 77030 | United States |
| Alamo City Clinical Research, LLC | San Antonio | Texas | 78258 | United States |
| Community Research Foundation | San Antonio | Texas | 78258 | United States |
| Neuropsychiatric Research Center of Southwest Florida | Bellevue | Washington | 98004 | United States |
| FG001 |
| Prior Placebo-DB |
Participants who received matched placebo in the double-blind study E2020-A001-219 (NCT00570128) were continued in this OLE study to be treated with donepezil titrated to achieve a final dose of 0.1 - 0.2 mg/kg/day using liquid formulated at 5 mg/5 mL for up to approximately Week 42. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Prior Donepezil-DB | Participants who received donepezil in the double-blind study E2020-A001-219 (NCT00570128) were continued in this OLE study to be treated with donepezil titrated to achieve a final dose of 0.1 - 0.2 mg/kg/day using liquid formulated at 5 mg/5 mL for up to approximately Week 42. |
| BG001 | Prior Placebo-DB | Participants who received matched placebo in the double-blind study E2020-A001-219 (NCT00570128) were continued in this OLE study to be treated with donepezil titrated to achieve a final dose of 0.1 - 0.2 mg/kg/day using liquid formulated at 5 mg/5 mL for up to approximately Week 42. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Visit 1 (Baseline) to Visit 4 or Early Termination in the Vineland Adaptive Behavior Scales, 2nd Edition, Parent/Caregiver Rating Form (VABS-II/PCRF) Sum of the 9 Sub-domain V-scores | VABS-II/PCRF assessed participant's adaptive behaviors on 3 domains (each has 3 sub-domains): Communication (receptive, expressive, written), Daily Living Skills (personal, domestic, community), Socialization (interpersonal relationships, play a leisure time, coping skills). Parent/caregiver rated participant's behavior for sub-domains from 0 (never present) to 2 (always present). Raw scores from sub-domains converted into standardized score(V-scale scores) ranged:1-24 for each sub-domain, mean=15,standard deviation(SD)=3,higher scores=higher level of adaptive functioning and were summed to obtain V-scale composite score ranged 9-216, mean=100,SD=15,higher scores=higher level of adaptive functioning, positive change=improvement in adaptive functioning. Composite and individual analyses, both raw and standardized scores, were not performed due to lack of significant differences between donepezil and placebo in parent study. | Analyses were performed on the Intent-to-treat population. The VABS-II/PCRF composite score, individual analyses of each of the 3 domains and the 9 sub-domains by both raw and standardized scores were not performed due to a lack of significant differences between donepezil and placebo subgroups; the data are provided as listings. | Posted | Mean | Standard Deviation | units on a scale | Visit 1 (baseline); Early Termination Visit (Week 36) |
|
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|
Baseline up to early termination visit (Week 36)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Prior Donepezil-DB | Participants who received donepezil in the double-blind study E2020-A001-219 (NCT00570128) were continued in this OLE study to be treated with donepezil titrated to achieve a final dose of 0.1 - 0.2 mg/kg/day using liquid formulated at 5 mg/5 mL for up to approximately Week 42. | 0 | 54 | 0 | 54 | 37 | 54 |
| EG001 | Prior Placebo-DB | Participants who received matched placebo in the double-blind study E2020-A001-219 (NCT00570128) were continued in this OLE study to be treated with donepezil titrated to achieve a final dose of 0.1 - 0.2 mg/kg/day using liquid formulated at 5 mg/5 mL up to approximately Week 42. | 0 | 63 | 0 | 63 | 48 | 63 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear pain | Ear and labyrinth disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Abdominal pain, upper | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Frequent bowel movements | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 11.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Pharyngitis, streptococcal | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
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| Abnormal behavior | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
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| Aggression | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Initial insomnia | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Oroparyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
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| Furuncle | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
This was an open-label trial that was terminated early by the Sponsor.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eisai Medical Services | Eisai Inc | 1-888-422-4743 | esi_medinfo@eisai.com |
| ID | Term |
|---|---|
| D004314 | Down Syndrome |
| ID | Term |
|---|---|
| D008607 | Intellectual Disability |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D000015 | Abnormalities, Multiple |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D025063 | Chromosome Disorders |
| D030342 | Genetic Diseases, Inborn |
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| ID | Term |
|---|---|
| D000077265 | Donepezil |
| ID | Term |
|---|---|
| D007189 | Indans |
| D007192 | Indenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011083 | Polycyclic Compounds |
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| Male |
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| Asian |
|
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
|