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Ketogenic Diet for Recurrent Glioblastoma (ERGO)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00575146
First Posted: December 18, 2007
Last Update Posted: May 2, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Evomed MedizinService GmbH
Information provided by (Responsible Party):
J. Rieger, University Hospital Tuebingen
Results First Submitted: June 18, 2013  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Recurrent Glioblastoma
Intervention: Dietary Supplement: TAVARLIN

  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
Ketogenic Diet unrestricted ketogenic diet (< 50-60 g carbohydrates per day) and dietary supplementary products provided by Tavarlin

Participant Flow:   Overall Study
    Ketogenic Diet
STARTED   20 
COMPLETED   17 
NOT COMPLETED   3 



  Baseline Characteristics


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Applicability as Measured by Discontinuation of Study Treatment Due to Intolerability   [ Time Frame: until progression for up to 12 months ]

2.  Secondary:   Progression-free-survival   [ Time Frame: until progression for up to 12 months ]

3.  Secondary:   Overall Survival   [ Time Frame: death/last contact, an average of about 1 year ]

4.  Secondary:   Frequency of Seizures   [ Time Frame: while on study treatment for up to 12 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

5.  Secondary:   Ketosis   [ Time Frame: while on study treatment for up to 12 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

6.  Secondary:   Quality of Life   [ Time Frame: while on study treatment for up to 12 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  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
Because of the small number of patients efficacy cannot be concluded by the results of the study


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Dr. Johannes Rieger
Organization: Dr. Senckenberg Institute of Neurooncology
phone: +49 69 6301 ext 87711
e-mail: johannes.rieger@med.uni-frankfurt.de


Publications of Results:

Responsible Party: J. Rieger, University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT00575146     History of Changes
Other Study ID Numbers: ERGO
First Submitted: December 17, 2007
First Posted: December 18, 2007
Results First Submitted: June 18, 2013
Results First Posted: December 13, 2013
Last Update Posted: May 2, 2014



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