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

What Was Tested

This registered phase 3 trial tested CRH (Corticotropin-Releasing Hormone).

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.

It had 1 arm (groups): I (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 112 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Participation in and completion of stipulated final follow-up periods for study NTI 0302, NTI 0303, or other designated studies. Have a Karnofsky Performance of \> 50 at Baseline. Capable of self-administration of subcutaneous injections twice daily or availability of assistance from caregiver. Ability to provide written informed consent or, if unable to provide, have a legal guardian or representative provide written informed consent. For women of childbearing potential: a negative serum pregnancy test at Baseline.

The full record lists 5 inclusion and 9 exclusion criteria; among the exclusions: concurrent enrollment in any investigational drug or device study, other than nti 0302, nti 0303, or other designated studies; systemic steroid use for any indication other than peritumoral brain edema; use or intended use of dexamethasone as an anti-emetic during study.

How the Study Was Run

Design: non-randomized, single-group and open-label.

Being open-label, the CRH (Corticotropin-Releasing Hormone) study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2005-07 with completion listed for 2009-03.

It ran at 32 sites in United States (25) and Canada (7).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Long Term Safety and Tolerability of hCRF (time frame: Prospective).

What This Means in Plain Language

Put simply, this is a phase 3, non-randomized trial of CRH (Corticotropin-Releasing Hormone) in 112 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the CRH (Corticotropin-Releasing Hormone) compound page, all human trials.