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Sponsors and Collaborators: |
Eisai Medical Research Inc. Eisai Limited |
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Information provided by: | Eisai Medical Research Inc. |
ClinicalTrials.gov Identifier: | NCT00688376 |
The purpose of this study is to evaluate the efficacy, safety and tolerability of donepezil in children with persistent attention impairment that is present at least 12 months after the completion of cancer treatment.
Condition | Intervention | Phase |
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Attention Impairment |
Drug: Donepezil hydrochloride Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Pharmacokinetics Study |
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 |
Enrollment: | 300 |
Study Start Date: | August 2008 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
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).
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2: Placebo Comparator |
Drug: Placebo
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). |
This is a double-blind, placebo-controlled, parallel group study in pediatric subjects who have persistent attention impairment following treatment for cancer. This trial has three phases: (1) pre-randomization to establish eligibility, (2) a 12-week, double-blind, placebo-controlled, parallel-group phase with dose escalation based on body weight, (3) a 12-week, blinded extension phase during which all subjects will receive active drug.
Ages Eligible for Study: | 6 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Exclusion Criteria:
Subjects who meet any of the following criteria will be excluded from the study:
Study Director: | Margaret Moline, Ph.D | Eisai Medical Research Inc. |
Responsible Party: | Eisai Medical Research Inc. ( Margaret Moline, PhD ) |
Study ID Numbers: | E2020-G000-333 |
Study First Received: | May 28, 2008 |
Last Updated: | April 16, 2009 |
ClinicalTrials.gov Identifier: | NCT00688376 History of Changes |
Health Authority: | United States: Food and Drug Administration; European Union: European Medicines Agency |
Attention cancer chemotherapy |
donepezil acetylcholinesterase inhibitor |
Nootropic Agents Cholinesterase Inhibitors Neurotransmitter Agents Donepezil Cholinergic Agents |
Nootropic Agents Cholinesterase Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses Physiological Effects of Drugs |
Donepezil Enzyme Inhibitors Cholinergic Agents Central Nervous System Agents Pharmacologic Actions |