Clinical Trial: Glyburide Advantage in Malignant Edema and Stroke Pilot

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Sig

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: Remedy Pharmaceuticals, Inc.

Current Primary Outcome: Rate of Recruitment [ Time Frame: 11 months ]

The number of months it took to enroll the 10 patients


Original Primary Outcome: Feasibility of recruiting target population [ Time Frame: 6 months ]

Current Secondary Outcome:

  • 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).


Original Secondary Outcome:

  • Safety and Tolerability [ Time Frame: 90 days ]
  • Pharmacokinetics/Pharmacodynamics [ Time Frame: 3 days ]
  • Clinical and MRI Outcome Data [ Time Frame: 90 days ]


Information By: Remedy Pharmaceuticals, Inc.

Dates:
Date Received: December 29, 2010
Date Started: May 2011
Date Completion:
Last Updated: May 14, 2014
Last Verified: May 2014