At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase III Double Blind, Placebo Controlled Study of Donepezil in the Irradiated Brain
In Brief
A Phase 3 clinical trial evaluating donepezil hydrochloride and Placebo for Brain Tumors and Metastatic Disease. Completed, enrolled 198 participants across 16 sites.
Detailed Summary
RATIONALE: Donepezil may help lessen confusion and fatigue and improve mood and quality of life in patients who have undergone radiation therapy for brain tumors. It is not yet known whether donepezil is more effective than a placebo in lessening side effects of radiation therapy in patients with brain tumors. PURPOSE: This randomized phase III trial is studying donepezil to see how well it works in lessening side effects of radiation therapy compared with a placebo in patients who have undergone radiation therapy for brain tumors.
Study Details
Timeline
Interventions
Weeks 1-6: One tablet Donepezil 5 mg given daily Weeks 7-24: Two Donepezil 5 mg tablets given daily
Weeks 1-6: One tablet per day Weeks 7-24: Two tablets per day