NCT00226655

An Open-Labeled, Extended-Use of XERECEPT (hCRF) for Patients in Studies NTI 0302, 0303, or Other Designated Studies

An Open-Labeled, Extended-Use of Human Corticotropin-Releasing Factor (hCRF) Intended for Patients Who Participate in Dexamethasone-Sparing Studies NTI 0302, NTI 0303, or Other Designated Studies

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 112 (actual)
• Sponsor: Celtic Pharma Development Services · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to examine the long-term safety and tolerability of human corticotropin-releasing factor (hCRF), XERECEPT®, in patients requiring dexamethasone (Decadron) to treat peritumoral brain edema. This open-label, extended-use study is open to all patients who participate in either of the blinded studies, NTI 0302, NTI 0303, or other designated studies, including patients who may have discontinued blinded study medication early but completed the protocol-stipulated follow-up periods.

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 [XERECEPT (corticorelin acetate injection)]	2mg/day

Timeline

• Start date: 2005-07-01
• Primary completion: 2009-03-01
• Completion: 2009-04-01
• First posted: 2005-09-27
• Last updated: 2012-08-31
• Results posted: 2012-08-31

Locations

32 sites across 2 countries: United States, Canada