Efficacy and Safety of Donepezil Hydrochloride in Preadolescent and Adolescent Children With Attention Impairment Following Cancer Treatment
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|ClinicalTrials.gov Identifier: NCT00688376|
Recruitment Status : Completed
First Posted : June 2, 2008
Last Update Posted : September 23, 2009
|Condition or disease||Intervention/treatment||Phase|
|Attention Impairment||Drug: Donepezil hydrochloride Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Randomized, Double-Blind, Placebo-Controlled Study of Efficacy and Safety of Donepezil Hydrochloride in Preadolescent and Adolescent Children With Attention Impairment Following Cancer Treatment|
|Study Start Date :||August 2008|
|Actual Primary Completion Date :||June 2009|
|Actual Study Completion Date :||September 2009|
Drug: Donepezil hydrochloride
During the 12-week Double-Blind Phase, subjects will receive oral donepezil hydrochloride tablets starting at a dose of 3 mg once daily. Doses will be increased incrementally at successive 3-week intervals on the basis of weight and tolerability. The final daily dose will be 3, 5, or 10 mg depending on body weight.
During the Blinded Extension Phase, all subjects will receive active treatment (donepezil).
Other Name: Aricept
|Placebo Comparator: 2||
During the 12-week Double-Blind Phase, subjects will receive matching placebo tablets (3, 5, of 10 mg) once daily.
During the 12-week Blinded Extension Phase, all subjects will receive active treatment (donepezil).
- Change in the TOVA-CPT (Test of Variables in Attention - Continuous Performance Test) reaction time variability measure (administered to subjects). [ Time Frame: Screening to week 12. ]
- Paired Assoc. Learning Test, Woodcock Johnson Decision Speed Test, Woodcock Johnson Mathematics Fluency; Go/No-Go Task (for subjects); Conners' Parent Rating Scale-Revised (S); Behavioral Rating Inventory of Executive Functioning (parent/legal guardian). [ Time Frame: Screening to Week 12. ]
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): NCT00688376
Show 31 Study Locations
|Study Director:||Margaret Moline, Ph.D||Eisai Inc.|