NCT00088166

XERECEPT® (hCRF) for Patients Requiring Dexamethasone to Treat Edema Associated With Brain Tumors

A Phase III Randomized, Double-Blind, Dexamethasone-Sparing Study Comparing Human Corticotropin-Releasing Factor (hCRF) to Placebo for Control of Symptoms Associated With Peritumoral Brain Edema in Patients With Malignant Brain Tumor Who Require Chronic Administration of High-Dose Dexamethasone

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Celtic Pharma Development Services · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the safety and efficacy of XERECEPT® to dexamethasone (Decadron) a common treatment for symptoms of brain swelling (edema). This study is specifically aimed at patients who require chronic high doses of dexamethasone to manage symptoms.

Detailed description

XERECEPT® is not a potential treatment for cancer, but may reduce the edema associated with tumors and as a result, decrease neurological symptoms.

Conditions

• Brain Edema
• Brain Tumor

Interventions

Type	Name	Description
DRUG	hCRF	hCRF ; open-label dexamethasone that the patient is currently taking
DRUG	placebo hCRF	placebo hCRF 2mg/day and open-label dexamethasone that they are taking

Timeline

• Start date: 2004-05-01
• Primary completion: 2008-03-01
• Completion: 2008-03-01
• First posted: 2004-07-22
• Last updated: 2014-08-13
• Results posted: 2014-08-13

Locations

34 sites across 2 countries: United States, Canada