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

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. Identifier: NCT01268683
Recruitment Status : Completed
First Posted : December 31, 2010
Results First Posted : June 6, 2014
Last Update Posted : June 6, 2014
University of Maryland
Massachusetts General Hospital
Information provided by (Responsible Party):
Remedy Pharmaceuticals, Inc.

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Ischemic Stroke
Intervention: Drug: RP-1127 (Glyburide for injection)

  Participant Flow

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
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)

  Baseline Characteristics

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

Baseline Measures
   RP-1127 (Glyburide for Injection) 
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   0 
Between 18 and 65 years   7 
>=65 years   3 
[Units: Years]
Mean (Standard Deviation)
 50.5  (15.3) 
[Units: Participants]
Female   7 
Male   3 
Region of Enrollment 
[Units: Participants]
United States   10 

  Outcome Measures

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

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

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

Publications of Results:
Other Publications:
Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: Remedy Pharmaceuticals, Inc. Identifier: NCT01268683     History of Changes
Other Study ID Numbers: RPI 201
First Submitted: December 29, 2010
First Posted: December 31, 2010
Results First Submitted: March 11, 2014
Results First Posted: June 6, 2014
Last Update Posted: June 6, 2014