Status:
COMPLETED
Glyburide Advantage in Malignant Edema and Stroke - Remedy Pharmaceuticals
Lead Sponsor:
Remedy Pharmaceuticals, Inc.
Conditions:
Ischemic Stroke
Malignant Edema
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
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...
Detailed Description
The study population consists of participants with a clinical diagnosis of acute severe anterior circulation ischemic stroke, a baseline diffusion weighted image (DWI) lesion between 82 and 300 cm3, a...
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
June 13 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 4 2016
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT01794182
Start Date
June 13 2013
End Date
April 4 2016
Last Update
November 12 2024
Active Locations (17)
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1
University of Arizona Medical Center
Tucson, Arizona, United States, 85719
2
Stanford University Medical Center
Stanford, California, United States, 94305
3
Yale University School of Medicine
New Haven, Connecticut, United States, 06510
4
University of Florida, Jacksonville
Jacksonville, Florida, United States, 32209