Glyburide Advantage in Malignant Edema and Stroke Pilot "GAMES-PILOT"

Completed

Phase 1/2 Results

Trial Description

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 Description

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.

Conditions

Interventions

  • RP-1127 (Glyburide for injection) Drug
    Other Names: glibenclamide; glybenclamide
    Intervention Desc: Bolus plus 72 hour IV infusion
    ARM 1: Kind: Experimental
    Label: RP-1127 (Glyburide for Injection)

Trial Design

  • Allocation: Non-Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Single Group Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Feasibility of recruiting target population 6 months No
Secondary Safety and tolerability 90 days Yes
Secondary Pharmacokinetics/pharmacodynamics 3 days Yes
Secondary Clinical and MRI outcome data 90 days No
Primary Rate of Recruitment 11 months No

Sponsors