Glyburide Advantage in Malignant Edema and Stroke Pilot (GAMES-PILOT)
The study objective is to assess the feasibility of enrolling, evaluating, and treating with RP-1127 (Glyburide for Injection) severe anterior circulation ischemic stroke patients, whether or not treated with standard of care IV rtPA. Patients must be between 18-80 years of age, must have a baseline diffusion weighted image (DWI) lesion volume 82 - 210 cm3, and time from symptom onset to start of study infusion must be ≤10 hr.
Drug: RP-1127 (Glyburide for injection)
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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.|
- Rate of Recruitment [ Time Frame: 11 months ] [ Designated as safety issue: No ]The number of months it took to enroll the 10 patients
- Safety and Tolerability [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: No ]The proportion of subjects with mRS <=4 expressed as a % (total number of patients with mRS <=4 divided by total number of patients enrolled).
|Study Start Date:||May 2011|
|Study Completion Date:||February 2013|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|