Clinical Trials Unit
Stanford University School of Medicine's Center for Advanced Dermatologic Investigation is the Dermatology Department's clinical trials unit.
The Center is home to 12-15 ongoing clinical studies, investigating the safety and efficacy of new and currently available drugs and over-the-counter medications. The Center works with Stanford's own panel on medical research, leading pharmaceutical companies,and the Food and Drug Administration to safely and ethically expand the medical field's knowledge of dermatologic treatments. New studies begin regularly, and the Center continues to recruit patients with skin aging, sun damage, skin cancer (including basal cell carcinomas), psoriasis, atopic dermatitis, rosacea, and other dermatologic diseases for ongoing studies.
Skin Aging Studies
We seek to understand the human aging processes as it relates to skin on a fundamental level. To this end, our studies focus on clinical and translational research efforts ranging from: (1) the analysis of gene changes which predispose individuals to exceptionally youthful skin to (2) molecular signatures that may be biomarkers for aging skin to (3) the careful study of new candidate agents which might affect the skin aging process.
Nonmelanoma Skin Cancer
Recent advances in our understanding of basal cell skin cancer biology have enabled the development of cutting edge study drugs which combat tumor growth. We are currently home to a number of clinical trials at the forefront of potential therapy for advanced or metastatic basal cell cancer. In addition, we seek to understand the biology of basal cell skin cancers and to identify molecular predictors for treatment success.
Acne Rosecea
This is a common and frustrating chronic inflammatory condition of the face, usually affecting older individuals. The causes of this complex condition are the subject of much study. Our clinical studies seek to identify new topical or oral medications to improve the symptoms of acne rosacea.
Contact
For more information, please email dermtrials@stanford.edu
Featured Clinical Trials
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.
Stanford Investigator(s):
Intervention(s):
- drug: Glyburide for Injection
- drug: Placebo
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
Psoriasis Clinical Trials
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.
Stanford Investigator(s):
Intervention(s):
- drug: Glyburide for Injection
- drug: Placebo
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
Dermatology Clinical Trials
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.
Stanford Investigator(s):
Intervention(s):
- drug: Glyburide for Injection
- drug: Placebo
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
Pediatric Dermatology Clinical Trials
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.
Stanford Investigator(s):
Intervention(s):
- drug: Glyburide for Injection
- drug: Placebo
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
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.
Stanford Investigator(s):
Intervention(s):
- drug: Glyburide for Injection
- drug: Placebo
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
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.
Stanford Investigator(s):
Intervention(s):
- drug: Glyburide for Injection
- drug: Placebo
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