drugset / Trial / NCT02460874

Glyburide vs Placebo as Prophylaxis Against Cerebral Edema in Patients Receiving Radiosurgery for Brain Metastases (RAD 1502/UAB 1593)

NCT02460874

Phase 1/2 Terminated 1 enrolled University of Alabama at Birmingham
RandomizedParallel-groupTriple-blindTreatment

Summary

Primary Objectives: Pilot Portion: To determine the feasibility and safety of administering oral glyburide to non-diabetic patients receiving stereotactic radiosurgery (SRS) for newly diagnosed brain metastases. Randomized Portion: To determine the number of patients with newly diagnosed brain metastases who have an increase in edema as measured on volumetric FLAIR imaging and the number of patients that require dexamethasone administration (or any corticosteroid administration with the purpose of treating cerebral edema) from the day of SRS to one month follow-up MRI in the group receiving glyburide versus placebo.

Timeline

Start
2017-08-16
Primary completion
2021-05-19
Completion
2021-05-19

Drugs

EvaluationDrugModalityDoseRoute
Subject Glyburide Small molecule 1.25 mg Oral