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XERECEPT® (hCRF) for Patients Requiring Dexamethasone to Treat Edema Associated With Brain Tumors

This study has been completed.
Sponsor:
Collaborator:
Neurobiological Technologies
Information provided by (Responsible Party):
Celtic Pharma Development Services
ClinicalTrials.gov Identifier:
NCT00088166
First received: July 20, 2004
Last updated: July 22, 2014
Last verified: July 2014
Results First Received: October 13, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Brain Edema
Brain Tumor
Interventions: Drug: hCRF
Drug: placebo hCRF

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
hCRF Patients will take hCRF (XERECEPT) 2mg/day and open label-dexamethasone they are currently taking.
Placebo Patient will receive placebo hCRF and any open-label dexamethasone that they are currently taking

Participant Flow:   Overall Study
    hCRF     Placebo  
STARTED     100     100  
COMPLETED     47     39  
NOT COMPLETED     53     61  
Adverse Event                 11                 9  
Death                 3                 1  
Lost to Follow-up                 0                 1  
Physician Decision                 4                 1  
Protocol Violation                 1                 5  
Patient deterioration                 29                 39  
Withdrawal by Subject                 5                 5  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
hCRF Patients will take hCRF (XERECEPT) 2mg/day and open label-dexamethasone they are currently taking.
Placebo Patient will receive placebo hCRF and any open-label dexamethasone that they are currently taking
Total Total of all reporting groups

Baseline Measures
    hCRF     Placebo     Total  
Number of Participants  
[units: participants]
  100     100     200  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     89     87     176  
>=65 years     11     13     24  
Age  
[units: years]
Mean ± Standard Deviation
  51.9  ± 11.8     52.7  ± 11.6     52.3  ± 11.7  
Gender  
[units: participants]
     
Female     43     43     86  
Male     57     57     114  
Region of Enrollment  
[units: participants]
     
United States     90     81     171  
Canada     7     15     22  
Australia     3     3     6  
New Zealand     0     1     1  



  Outcome Measures
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1.  Primary:   The Proportion of Patients in Each Treatment Group Who Are Responders at Week 2 and Continue to be Responders at Week 5   [ Time Frame: Prospective ]

2.  Secondary:   Percent of Patients in Each Treatment Group Achieving 50% Reduction in Dexamethasone Usage Relative to Baseline by Week 2 Without Deterioration in Neurological Function as Measured by the 10-Item Neurological Exam and the KPS   [ Time Frame: Prospective ]

3.  Secondary:   The Proportion of Patients in Each Treatment Group Who Are Responders at Week 2 and Who Continue to be Responders at Weeks 5 and 8   [ Time Frame: Prospective ]

4.  Secondary:   Change From Baseline in the 10-Item Neurological Examination Score at Weeks 2, 5, 8 12 and 16 (or Early Discontinuation)   [ Time Frame: Prospective ]

5.  Secondary:   Change From Baseline in the Karnofsky Performance Score   [ Time Frame: Prospective ]

6.  Secondary:   Change From Baseline in the FACT-Br Quality of Life Results   [ Time Frame: Prospective ]

7.  Secondary:   Change From Baseline in Myopathy Assessment Results at Week 12 (or Early Study Drug Discontinuation) and Week 16 (or 4-week Follow-up Visit)   [ Time Frame: Prospective ]

8.  Secondary:   Maximum Percent Reduction in Dexamethasone Usage Relative to Baseline Achieved During the Study   [ Time Frame: Prospective ]

9.  Secondary:   Number of Patients Who Discontinued Study Drug Prior to the End of Week 5   [ Time Frame: Prospective ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Patrick O'Connor, MD, Managing Director Clinical Development
Organization: Celtic Pharma Development Services America Inc
phone: 212-616-4050
e-mail: patrick.oconnor@dev.celticpharma.com


No publications provided by Celtic Pharma Development Services

Publications automatically indexed to this study:

Responsible Party: Celtic Pharma Development Services
ClinicalTrials.gov Identifier: NCT00088166     History of Changes
Obsolete Identifiers: NCT00091013
Other Study ID Numbers: NTI 0303, XERECEPT®
Study First Received: July 20, 2004
Results First Received: October 13, 2011
Last Updated: July 22, 2014
Health Authority: United States: Food and Drug Administration