| September 23, 2005 |
| December 27, 2007 |
| January 2006 |
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| The primary efficacy endpoint is the proportion of responders, i.e. patients in each treatment group who show improvement at the end of Week 1 and continue to be classified as improved relative to Baseline at Week 2. [ Time Frame: Prospective ] [ Designated as safety issue: Yes ] |
- The primary efficacy endpoint is the proportion of reponders, i.e. patients in each treatment group who show improvement at the end of Week 1 and continue to be classified as improved relative to Baseline at Week 2. Improvement is defined as:
- -Lower overall score on the 10-item Neurological Exam of at least 25% relative to Baseline, and
- -Karnofsky Performance Score unchanged or increased relative to Baseline, and
- -No post-Baseline increase in dexamethasone dose on more than 1 day, with a maximum allowable increase of less than 4mg on that day.
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| Complete list of historical versions of study NCT00226668 on ClinicalTrials.gov Archive Site |
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| XERECEPT® (hCRF) for Primary Glioma Patients Requiring Dexamethasone to Treat Peritumoral Brain Edema |
| A Phase III Randomized, Double-Blind Study Comparing Human Corticotropin-Releasing Factor (hCRF) to Dexamethasone for Control of Symptoms Associated With Peritumoral Brain Edema in Patients With Primary Malignant Glioma |
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. |
XERECEPT is not a potential treatment for cancer, but may reduce the edema associated with tumors and as a result, decrease neurological symptoms. |
| Phase III |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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- Drug: hCRF
- Drug: placebo hCRF
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- Experimental: Patients will receive hCRf (XERECEPT) 2mg/day and dexamethasone 4 mg/day along with any open-label dexamethasone that they may be taking
- Placebo Comparator: Patients will receive placebo hCRF (XERECEPT) 2mg/day and dexamethasone 4 mg/day along with any open-label dexamethasone they may be taking
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| Withdrawn |
| 120 |
| January 2008 |
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Inclusion Criteria:
- Histologically confirmed diagnosis of a primary malignant glioma.
- Symptomatic peritumoral brain edema requiring initiation or increase of dexamethasone treatment.
- If a patient is on dexamethasone for treatment of symptomatic peritumoral brain edema, the dose must be stable and should not exceed 24mg/dl for a minimum of 7 days prior to Baseline.
- Presence of peritumoral brain edema confirmed by MRI scan or comparable diagnostic technology obtained within 21 days of Baseline.
- Capable of self-administration of subcutaneous injections twice daily for 8 weeks or availability of assistance from caregiver.
Exclusion Criteria:
- Need for surgery, radiosurgery or radiation therapy or the introduction of new chemotherapeutic regime within 2 weeks of study treatment.
- Systemic steroid use for any other indication than peritumoral brain edema.
- Patients on dexamethasone or anticonvulsant therapy.
- Serious concomitant cardiovascular, pulmonary, renal, gastrointestinal or endocrine metabolic disease which could put the patient at unusual risk for study participation.
- Central nervous system (CNS) infection.
- Conditions that are considered contradictions for patients to receive niacin
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| Both |
| 18 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States, Canada |
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| NCT00226668 |
| Patrick Rossi, MD - Medical Monitor, Celtic Pharma Development Services |
| NTI 0302, corticorelin acetate injection |
| Celtic Pharma Development Services |
| Neurobiological Technologies |
| Principal Investigator: |
William Shapiro, MD |
Barrow Neurological Institute |
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| Celtic Pharma Development Services |
| December 2007 |