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.
- Drug: Glyburide for Injection
- Drug: Placebo
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
- Evidence (clinical or imaging) of concurrent infarction in the contralateral
hemisphere deemed by the investigator to be sufficiently serious so as to affect
- 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
- Severe renal disorder from the patient's history (e.g. dialysis) or eGFR of < 30
- 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);
- 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
- 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