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XERECEPT® (hCRF) for Primary Glioma Patients Requiring Dexamethasone to Treat Peritumoral Brain Edema

NCT00226668 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2008-01-03

No results posted yet for this study

Summary

The purpose of this study is to examine the safety and efficacy of XERECEPT (human Corticotropin-Releasing Factor, or hCRF) compared to dexamethasone in patients with primary malignant glioma who require increased dexamethasone doses to control symptom of peritumoral brain edema.

Conditions

Interventions

DRUG

hCRF

hCRF 2mg/day; dexamethasone 4mg/day along with any open-label dexamethasone they may be taking

DRUG

placebo hCRF

placebo hCRF 2mg/day, dexamethasone 4mg/day and any open-label dexamethasone they may be taking

Sponsors & Collaborators

  • Neurobiological Technologies

    collaborator INDUSTRY

  • Celtic Pharma Development Services

    lead INDUSTRY

Principal Investigators

  • William Shapiro, MD · Barrow Neurological Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-01-31
Completion
2008-01-31

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00226668 on ClinicalTrials.gov