Glyburide Advantage in Malignant Edema and Stroke Pilot (GAMES-PILOT)

This study has been completed.
Sponsor:
Collaborators:
University of Maryland
Massachusetts General Hospital
Information provided by (Responsible Party):
Remedy Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01268683
First received: December 29, 2010
Last updated: May 14, 2014
Last verified: May 2014
Results First Received: March 11, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Ischemic Stroke
Intervention: Drug: RP-1127 (Glyburide for injection)

  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
Between February 2011, and May 2012, ten subjects were enrolled and treated at University of Maryland and the Massachusetts General Hospital within 9.6 months at 2 sites.

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
RP-1127 (Glyburide for Injection) RP-1127 (Glyburide for injection) : Bolus plus 72 hour IV infusion; total of 3mg/day

Participant Flow:   Overall Study
    RP-1127 (Glyburide for Injection)  
STARTED     10  
COMPLETED     10  
NOT COMPLETED     0  



  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
RP-1127 (Glyburide for Injection) RP-1127 (Glyburide for injection) : Bolus plus 72 hour IV infusion

Baseline Measures
    RP-1127 (Glyburide for Injection)  
Number of Participants  
[units: participants]
  10  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     7  
>=65 years     3  
Age  
[units: years]
Mean ± Standard Deviation
  50.5  ± 15.3  
Gender  
[units: participants]
 
Female     7  
Male     3  
Region of Enrollment  
[units: participants]
 
United States     10  



  Outcome Measures
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1.  Primary:   Rate of Recruitment   [ Time Frame: 11 months ]

2.  Secondary:   Safety and Tolerability   [ Time Frame: 90 days ]

3.  Secondary:   Pharmacokinetics/Pharmacodynamics   [ Time Frame: 3 days ]

4.  Secondary:   Clinical and MRI Outcome Data   [ Time Frame: 90 days ]


  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
The trial was a single arm; there is thus no placebo to compare RP-1127 to.


  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: Sven Jacobson
Organization: Remedy Pharmaceuticals, Inc.
phone: 212 586 2226 ext 225
e-mail: sven@remedypharmaceuticals.com


Publications of Results:
Other Publications:
Publications automatically indexed to this study:

Responsible Party: Remedy Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01268683     History of Changes
Other Study ID Numbers: RPI 201
Study First Received: December 29, 2010
Results First Received: March 11, 2014
Last Updated: May 14, 2014
Health Authority: United States: Food and Drug Administration