Glyburide Advantage in Malignant Edema and Stroke Pilot (GAMES-PILOT)
|ClinicalTrials.gov Identifier: NCT01268683|
Recruitment Status : Completed
First Posted : December 31, 2010
Results First Posted : June 6, 2014
Last Update Posted : June 6, 2014
|Condition or disease||Intervention/treatment||Phase|
|Ischemic Stroke||Drug: RP-1127 (Glyburide for injection)||Phase 1 Phase 2|
This is a multi-center, prospective, open label, Phase IIa trial of RP-1127 (Glyburide for Injection) in 10 patients with a severe anterior circulation ischemic stroke who are likely to experience clinically significant brain swelling.
Subjects will receive RP-1127 (Glyburide for Injection), delivered as an IV bolus followed by an IV infusion for 72 hours.
Subjects will have a baseline (pretreatment) MRI scan as standard of care, and three follow up MRI scans (at 24+12 hours, 48+12 hours, and 72±12 hours). Since recanalization may have an effect on outcome, the results of vascular studies, obtained as part of standard of care and defined as CTA, MRA or catheter angiography of the head and neck, will be recorded. Additionally, clinical endpoints such as the NIHSS, GCS and FOUR Score (baseline, 24±12 hour, 48±12 hour, 72±12 hour and 7±1 days) and mRS (30±5 days and 90±7 days) will be assessed. Safety parameters will be assessed through Day 7 or discharge (whichever is sooner), and then again at Day 30±5 and Day 90±7.
Study participation is expected to last 90±7 days.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multi-center, Prospective, Open Label, Phase IIa Trial of RP-1127 (Glyburide for Injection) in Patients With a Severe Anterior Circulation Ischemic Stroke Who Are Likely to Experience Clinically Significant Brain Swelling.|
|Study Start Date :||May 2011|
|Actual Primary Completion Date :||June 2012|
|Actual Study Completion Date :||February 2013|
Experimental: RP-1127 (Glyburide for Injection)
This arm is administered a RP-1127 bolus followed by continuous infusion of RP-1127 for 72 hours
Drug: RP-1127 (Glyburide for injection)
Bolus plus 72 hour IV infusion
Other Name: glibenclamide
- Rate of Recruitment [ Time Frame: 11 months ]The number of months it took to enroll the 10 patients
- Safety and Tolerability [ Time Frame: 90 days ]
AE's of special interest (cardiac events, difficulty controlling blood sugar, liver problems, and blood disorders, including anemia) will be followed for 30 days and all SAE's will be followed for 90 days.
SAE's and AE's were reviewed, and the number of subjects with unanticipated adverse events, or drug-related SAE's were assessed.
- Pharmacokinetics/Pharmacodynamics [ Time Frame: 3 days ]The number of patients with unanticipated PK or PD responses was assessed. An unanticipated PK or PD response would have been, for instance, a peak concentration inconsistent with prior PK assessments, or an unexpectedly low blood glucose level (< 40 mg/dL)
- Clinical and MRI Outcome Data [ Time Frame: 90 days ]The proportion of subjects with mRS <=4 expressed as a % (total number of patients with mRS <=4 divided by total number of patients enrolled).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01268683
|United States, Illinois|
|Rush University Medical Center|
|Chicago, Illinois, United States, 60612|
|United States, Maryland|
|University of Maryland Medical Center|
|Baltimore, Maryland, United States|
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States|
|United States, Pennsylvania|
|University of Pittsburgh Medical Center|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Kevin Sheth, MD||University of Maryland|