Trial Search Results

Glyburide Advantage in Malignant Edema and Stroke - Remedy Pharmaceuticals

This is a randomized, multi-center, prospective, double blind study. The primary objective is to assess the efficacy and safety of glyburide (RP-1127) compared to placebo in participants with a severe anterior circulation ischemic stroke who are likely to develop malignant edema.This objective will be addressed by comparing the proportion of glyburide treated particpants and placebo treated participants with a Day 90 modified Rankin Scale (mRS) ≤ 4 without decompressive craniectomy (DC). The secondary objective is to assess the efficacy of RP-1127 compared to placebo in participants with a severe anterior circulation ischemic stroke who were likely to develop malignant edema.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Biogen

Stanford Investigator(s):

Intervention(s):

  • Drug: Glyburide for Injection
  • Drug: Placebo

Phase:

Phase 2

Eligibility


Key Inclusion Criteria:

   - A clinical diagnosis of acute ischemic stroke in the MCA territory (PCA and/or ACA
   territory involvement in addition to primary MCA territory stroke is acceptable).

   - Prior to stroke, no disability, or no significant disability despite symptoms (able to
   carry out all usual duties and activities).

   - A baseline DWI lesion between 82 and 300 cm3 on MRI.

   - Patients treated with IV rtPA should meet established criteria for IV rtPA
   administration in the 0-3 and 3-4.5 hr time periods at the time of rtPA administration
   (if rtPA is administered in the 3-4.5 hr time window, the NIHSS must be ≤ 25 at the
   time of rtPA administration).

   - The time to the start of infusion of Study Drug must be ≤ 10 hours after time of
   symptom onset, if known, or the time last seen well [termed "time last known at
   neurologic baseline" (TLK@B)].

   - Provision of written informed consent by a legally authorized representative according
   to institutional guidelines and national regulations.

Key Exclusion Criteria:

   - Commitment to decompressive craniectomy (DC) prior to enrollment, or following
   enrollment and prior to start of Study Drug.

   - Treatment with intra-arterial (IA) rtPA or by mechanical means for clot disruption.

   - Patients unable to tolerate MRI scanning, e.g. those with pacemakers or automatic
   defibrillators.

   - Evidence (clinical or imaging) of concurrent infarction in the contralateral
   hemisphere deemed by the investigator to be sufficiently serious so as to affect
   functional outcome.

   - Clinical signs of herniation, e.g. one or two dilated, fixed pupils; unconsciousness
   (i.e., ≥ 2 on item 1a on the NIHSS); and/or loss of other brain stem reflexes
   attributable to edema or herniation according to the investigator's judgment.

   - Hemorrhage (other than small petechial hemorrhages) on CT/MRI, or CT/MRI evidence of
   anteroseptal/pineal shift greater ≥2 mm prior to enrollment that is due to cerebral
   edema.

   - Severe renal disorder from the patient's history (e.g. dialysis) or eGFR of < 30
   mL/min/1.73 m2.

   - Severe liver disease or ALT >3 times normal, or bilirubin >2 times normal.

   - Blood glucose <55 mg/dL at enrollment or immediately prior to administration of Study
   Drug, or a clinically significant history of hypoglycemia.

   - Acute ST elevation myocardial infarction, and/or acute decompensated HF, and/or
   QTc>520 ms, and/or known history of cardiac arrest (PEA, VT, VF, asystole), and/or
   admission for an ACS, MI, or coronary intervention (PCI or coronary artery surgery)
   within the past 3 months.

   - Known sulfonylurea treatment within 7 days. Sulfonylureas include glyburide
   /glibenclamide (Diabeta, Glynase); glyburide plus metformin (Glucovance); glimepiride
   (Amaryl); repaglinide (Prandin); netaglinide (Starlix); glipizide (Glucotrol,
   GlibeneseR, MinodiabR); gliclazide (DiamicronR); tolbutamide (Orinase, Tolinase);
   glibornuride (Glutril).

   - Known allergy to sulfa or specific allergy to sulfonylurea drugs.

   - Known G6PD enzyme deficiency.

   - Pregnant women. Women must be either post-menopausal (as confirmed by the LAR),
   permanently sterilized or, if ≤ 50 years old must have a negative test for pregnancy
   obtained before enrollment.

   - Breast-feeding women who do not agree (or their LAR does not agree) to stop breast-
   feeding during Study Drug infusion and for 7 days following the end of Study Drug
   infusion.

   - Patients already enrolled in a non-observation-only stroke study, or with
   life-expectancy <3 months not related to current stroke, or those unlikely to be
   compliant with follow up.

   - Patients currently receiving an investigational drug.

   - Patients in whom a peripheral IV line cannot be placed.

   - Mentally incompetent (prior to qualifying stroke) patients and wards of the state.

   - Patients who, in the opinion of the investigator, are not suitable for the study
   (reason to be documented).

NOTE: Other protocol defined inclusion/exclusion criteria may apply

Ages Eligible for Study

18 Years - 80 Years

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Stephanie Kemp
skemp@stanford.edu
Recruiting