Griffith Harsh
An Open-Labeled, Extended-Use of XERECEPT (hCRF) for Patients in Studies NTI 0302, 0303, or Other Designated Studies
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
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.
Recruiting Status:
CompletedStanford Recruiting Status:
No longer recruitingCondition(s):
Intervention(s):
- Drug: XERECEPT (corticorelin acetate injection)
Phase:
Phase 3Eligibility
Ages Eligible for Study:
18 years to Any AgeGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
- Participation in and completion of stipulated final follow-up periods for study NTI 0302, NTI 0303, or other designated studies.
- 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.
Key Exclusion Criteria:
- 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.
- Clinical signs and symptoms of cerebral herniation.
- Serious concomitant cardiovascular, pulmonary, renal, gastrointestinal or endocrine metabolic disease which could put the patient at unusual risk during study participation.
- Clinically significant head injury or chronic seizure disorder, if the condition results in functional impairment or is likely to interfere with evaluations.(Maintenance anticonvulsant therapy is allowed)
Additional Study Details
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 StudiesAnticipated start date:
8/23/2005Lead Sponsor:
Neurobiological Technologies, Inc.Collaborator(s):
- Celtic Pharma Development Services
Investigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
Non-randomizedMasking:
OpenControl:
noneAssignment:
Single GroupEndpoints:
SafetyPrimary Outcomes:
- The study will evaluate the overall long-term safety and tolerability of hCRF and steroid toxicities by monitoring dexamethasone dosing, laboratory values, adverse events,electrocardiograms and neurological and clinical status.
Total Number to be Enrolled:
340Total Number to be Enrolled at Stanford:
25More Information
Secondary ID(s):
- 96346
- BRN0002
- NCT00226655
- NTI 0501
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
6/4/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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