[Lani]

the trial on which the orphan drug approval was based


An Open-Labeled, Extended-Use of XERECEPT (hCRF) for Patients in Studies NTI 0302, 0303, or Other Designated Studies
This study has been completed.

First Received on September 23, 2005. Last Updated on April 28, 2009 History of Changes
Sponsor: Celtic Pharma Development Services
Collaborator: Neurobiological Technologies
Information provided by: Celtic Pharma Development Services
ClinicalTrials.gov Identifier: NCT00226655
Purpose
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.

Condition Intervention Phase
Brain Edema
Brain Tumor
Drug: hCRF [XERECEPT (corticorelin acetate injection)]
Phase III

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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


hCRF is a copy of a substance the brain uses to stimulate through several steps the body's own release of cortocosteroids from the adrenal gland, I believe