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Glyburide Advantage in Malignant Edema and Stroke - Remedy Pharmaceuticals (GAMES-RP)
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This is a randomized, multi-center, prospective, double blind, two-stage, adaptive study. The primary objective is to demonstrate the efficacy of RP-1127 compared to placebo in subjects with a severe anterior circulation ischemic stroke who are likely to develop malignant edema. This objective will be addressed by comparing the proportion of RP-1127 treated patients and placebo treated patients with a Day 90 modified Rankin Scale (mRS) ≤ 4 without decompressive craniectomy (DC).
Ischemic Stroke
Malignant Edema
Drug: RP-1127 (Glyburide for Injection)
Phase 2
|Study Type:
|Study Design:
|Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:
|A Randomized, Multi-center, Prospective, Double Blind, Two-stage, Adaptive Phase II Trial of RP- 1127 (Glyburide for Injection) in Patients With a Severe Anterior Circulation Ischemic Stroke Who Are Likely to Develop Malignant Edema
- The proportion of patients with a modified Rankin Scale (mRS) at Day 90 ≤ 4 without decompressive craniectomy [ Time Frame: 90 Days ] [ Designated as safety issue: No ]
- Safety of RP-1127 in subjects with a severe anterior circulation ischemic stroke who are likely to develop malignant edema. [ Time Frame: 90 Days ] [ Designated as safety issue: Yes ]Addressed by comparing the frequency and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)in the RP-1127 and placebo groups, with a specific focus on all cause mortality, cardiac mortality, and cardiac-related and blood glucose-related AEs/SAEs.
- Proportion of subjects that develop malignant edema [ Time Frame: 7 days ] [ Designated as safety issue: No ]
- Proportion of subjects undergoing DC, and DC-associated AEs and SAEs [ Time Frame: 90 Days ] [ Designated as safety issue: Yes ]
- Proportion of subjects that experience early neurological deterioration [ Time Frame: 72 Hours ] [ Designated as safety issue: No ]
- Proportion of subjects that develop parenchymal hematomas [ Time Frame: 7 Days ] [ Designated as safety issue: No ]
- Ipsilateral hemispheric swelling measured by MRI [ Time Frame: 96 Hours ] [ Designated as safety issue: No ]
- Proportion of subjects with 90 day mRS 0-3 and 0-4 [ Time Frame: 90 Day ] [ Designated as safety issue: No ]
- Activities of Daily Living (as measured by the Barthel Index) at 90 days [ Time Frame: 90 Days ] [ Designated as safety issue: No ]
- All-cause mortality at 90 days [ Time Frame: 90 Days ] [ Designated as safety issue: Yes ]
|Estimated Enrollment:
|Study Start Date:
|May 2013
|Estimated Study Completion Date:
|February 2015
|Estimated Primary Completion Date:
|November 2014 (Final data collection date for primary outcome measure)
|Assigned Interventions
Placebo Comparator: Matching Placebo
Subjects will receive matching placebo.
Experimental: RP-1127 (Glyburide for Injection)
Subjects will receive the active agent, RP-1127 (Glyburide for Injection)
Drug: RP-1127 (Glyburide for Injection)
Glyburide (5-chloro-N-(4-[N-(cyclohexylcarbamoyl) sulfamoyl]phenethyl)-2- methoxybenzamide) is an anti-diabetic medication in a class of medications known as sulfonylureas. RP-1127 is a formulation of glyburide designed for intravenous administration.
Other Names:
Detailed Description:
The study population consists of subjects with a clinical diagnosis of acute severe anterior circulation ischemic stroke, a baseline diffusion weighted image (DWI) lesion between 82 and 300 cm3, age 18-80 years, and time from symptom onset to start of study infusion of ≤10 hours. The study will enroll both patients that do not receive IV rtPA and those that receive IV rtPA within 4.5 hours of stroke.
Stage 1 of the study will enroll and treat up to a maximum of 50 subjects (25 per arm) who meet all inclusion/exclusion.
Enrollment will be randomized controlling for site, age ≤60 (yes/no), and IV rtPA treatment at baseline (yes/no). Subjects will be randomized equally between RP-1127 and placebo.
|Ages Eligible for Study:
|18 Years to 80 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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)].
- Age ≥18 years and ≤80 years.
- Provision of written informed consent by a legally authorized representative according to institutional guidelines and national regulations.
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01794182
|Contact: Kevin N Sheth, MD
|Contact: W. Taylor Kimberly, MD, PhD
|United States, Arizona
|University of Arizona Medical Center
|Not yet recruiting
|Tucson, Arizona, United States, 85719
|Contact: Kendra Drake firstname.lastname@example.com
|United States, California
|Stanford University Medical Center
|Stanford, California, United States, 94305
|Contact: Gregory W Albers, MD 650-494-3848
|United States, Connecticut
|Yale University School of Medicine
|New Haven, Connecticut, United States, 06510
|Principal Investigator: Kevin N Sheth, MD
|United States, Florida
|University of Florida, Jacksonville
|Jacksonville, Florida, United States, 32209
|Contact: Scott Silliman email@example.com
|United States, Illinois
|Northwestern Memorial Hospital
|Chicago, Illinois, United States, 60611
|Contact: Shyam K Prabhakaran, MD 312-503-2994
|United States, Kentucky
|University of Louisville Hospital
|Louisville, Kentucky, United States, 40202
|Contact: Ann Jerde 502-813-6579 email@example.com
|United States, Maine
|Maine Medical Center
|Scarborough, Maine, United States, 04074
|Contact: Paul Muscat, MD 207-883-1414
|United States, Maryland
|University of Maryland School of Medicine
|Baltimore, Maryland, United States, 21201
|Contact: Carolyn Cronin, 410-328-3871
|United States, Massachusetts
|Massachusetts General Hospital
|Boston, Massachusetts, United States, 02114
|Contact: W. Taylor Kimberly, MD, PhD 857-238-5644 firstname.lastname@example.com
|Principal Investigator: W. Taylor Kimberly, MD, PhD
|UMASS Memorial Medical Center
|Worcester, Massachusetts, United States, 01655
|Contact: Raphael A Carandang, MD 508-334-2527
|United States, Ohio
|Cleveland Clinic
|Cleveland, Ohio, United States, 44195
|Contact: Jennifer Turczyk 216-445-4488 firstname.lastname@example.com
|Ohio State University Wexner Medical Center
|Columbus, Ohio, United States, 43210
|Contact: Michel T Torbey, MD 614-293-4966
|United States, Oregon
|Oregon Health & Science University Hospital
|Portland, Oregon, United States, 97239
|Contact: Holly E Hinson, MD 503-418-1472
|United States, Pennsylvania
|Abington Memorial Hospital
|Abington, Pennsylvania, United States, 19001
|Contact: Osman Kozak firstname.lastname@example.com
|UPMC Presbyterian Hospital
|Pittsburgh, Pennsylvania, United States, 15213
|Contact: Bradley Molyneaux firstname.lastname@example.com
|United States, South Carolina
|Medical University of South Carolina
|Charleston, South Carolina, United States, 29425
|United States, Utah
|University of Utah Healthcare
|Salt Lake City, Utah, United States, 84132
|Contact: Jennifer Majersik email@example.com
|Principal Investigator:
|Kevin N Sheth, MD
|Yale University
|Principal Investigator:
|W. Taylor Kimberly, MD, PhD
|Massachusetts General Hospital
No publications provided
|Responsible Party:
|Remedy Pharmaceuticals, Inc.
|ClinicalTrials.gov Identifier:
|NCT01794182 History of Changes
|Other Study ID Numbers:
|Study First Received:
|February 14, 2013
|Last Updated:
|June 3, 2014
|Health Authority:
|United States: Food and Drug Administration
Additional relevant MeSH terms:
Gas Gangrene
Bacillaceae Infections
Bacterial Infections
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Clostridium Infections
Gram-Positive Bacterial Infections
Nervous System Diseases
Signs and Symptoms
Vascular Diseases
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs
ClinicalTrials.gov processed this record on May 26, 2015


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Tether-It Bands
With its 23" retractable cord, Tether It! Keeps small items easy to find. Simply attach items to the metal ring or snap holder to keep them close at hand. Convenient and durable metal clip easily hooks to belt loop or purse. 2 1/2"L x 1 1/2"W.
|May We Suggest
|**In order to join, you need to have at least
1 item in your shopping cart.

subset: commoncrawl


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Every day is a new kind of exciting at Girl Scout Camp. You will try new things, make great friends, get in sync with nature and immerse yourself in a world so different from home.
Camp is an all-girl world where belonging is key and confidence blooms. Girls learn differently than boys and everything here is designed just for you.
Whether you're dancing like no one's watching, getting messy in the barn and not giving a hoot who sees or dreaming up your latest super hero powers, you get to be exactly who you want to be.
A summer at Girl Scout Camp is a summer you'll never forget!
Troops and Families have options at camp too!
Activities at camps may include:
Selling cookies can give your Girl Scout Cookie Credits to spend towards camp fees. You can also purchase camp Gift Cards at GSCO's Shops (a great gift idea for Grandparents and relatives!)
Is your daughter ready for camp? Take Ready for Camp Quiz! to find out.
You don't have to wait for summer to have a great Girl Scout camp experience! Year-round camping opportunities are available. Use Activity Finder Tool to get started, or book a stay at one of our lodges or properties that is available year-round!
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The Golden Lions have suffered three new injuries after their 38-23 win over the Free State Cheetahs last Saturday.
The major loss is lock Hendrik Roodt, who recently recovered from injury. Roodt is expected to be out for the season as he suffered a shoulder dislocation.
Flank Willie Britz and wing Deon Helberg are also out of action with wrist and ankle injuries respectively.
The Lions are already without scrumhalf Whestley Moolman (arm) and lock Stephan Greeff (leg) for the rest of the season. Flank Derick Minnie (knee), flyhalf Guy Cronje (hamstring) and centre Waylon Murray (knee) are recovering and are set to make their returns over the next two to three weeks.
There is some good news for the Lions as flank Jaco Kriel and prop CJ van der Linde rejoined the squad at training on Monday.


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last stand wrote:nelly?
what is this 2002?
Funny, I just heard a country song playing in the gym and thought that was odd (for my gym), and then I heard Nelly "rapping" on there and thought "Thats why........Wait......where's he been?!"
last stand wrote:nelly?
what is this 2002?
KB24 wrote:Never liked Nelly...one of this new age wack wanna be gangstas.
KB24 wrote:Never liked Nelly...one of this new age wack wanna be gangstas.
KB24 wrote:Never liked Nelly...one of this new age wack wanna be gangstas.
chingy248 wrote:Judging by Kobe's instagram post at 4am this morning... I guess he heard what Nelly said lol
MadMax wrote:chingy248 wrote:Judging by Kobe's instagram post at 4am this morning... I guess he heard what Nelly said lol
What was it?
Dr. Robert Klapper @DrRobertKlapper 24h
Music has No language barrier.Neither does Art.There is one word understood in ALL languages..KOBE!
Dr. Robert Klapper @DrRobertKlapper 23h
We will know everything about KOBE's return date when we see ONE milestone achieved. When he begins to JUMP. It's coming in next phase
Ray Allen said this, Now Nelly says it, its no surprise. For every fan out there, dont listen to Kobe fans, they are the most delusional, history revisionist you will ever find in the NBA community. Kobe has been a diva, is selfish, and highly overrated, hes not even clutch. Kobe has talent, has the competitive fire, but hes over the top egotistical
Finally someone said the ugly truth about Lakers. It has been Kobe's team for a long time and many people have said he's hard to play with. Howard had no problem with the pressure. Look at how well he performed in Orlando being the only superstar there.
no one wants to come to the lakers to play with kobe.. kobe reminds me of that kid back in p.e. class that you had to play basketball with.. he had a effed up attitude jocky bratty kid that was aggressive and competitive so much, that he made it not fun to play anymore..
best debate ive seen on first take! nelly killed them. they wouldnt answer them questuons about kobe
Nelly was bringing it to SAS...and Skip was just sittin' back, taking it in. Nelly even had to get the moderator in check, when she tried to help SAS. It WAS one of the best First Take debates EVER. I liked when Nelly asked the three of them to name the other starters that went to the Finals with D12. And he never backed down as othere often do.
V.V.V.V.V. wrote:I can't believe I watched the whole Nelly interview. And I thought that SAS was difficult and irrational. He was actually the voice of reason compared to Nelly.
I suppose that the only reason that Nelly is irrationally defending Dwight is because they're friends. Otherwise, it makes no sense to me that when confronted with the question "Why is it that Dwight didn't want to play with Kobe? " , Nelly implies that it must be something wrong with Kobe, not Dwight.
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About a week ago I made the last minute decision to travel to Quebec, Canada for World Championships. The first few days there were beautiful and sunny, and the pipe was better than I had hoped for. Practice went well, but I kept my expectations low. I ride better with less pressure. The contest day turned out to be pretty snowy, so there was about a foot of pow in the flat bottom. The conditions made the pipe pretty slow, but it was a level playing field. Everyone had to ride the same half pipe.
In my first run I ended up putting down a mellow run with two fives and two sevens in it, and my score ended up putting me in first place. It was obviously more than I expected and I couldn't have been more thrilled. But it was the first run and I didn't put it past the other girls to beat my score. The competition slowly came to an end as we shredded the pow that was in the shape of a halfpipe, and my first place run held its spot. Now looking forward to X-Games and riding with my friends/competitors.


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Movies about fatherhood
Published On: May 23 2013 07:01:20 AM PDT Updated On: May 28 2014 07:19:17 AM PDT
This Father's Day consider watching one of these movies about dads and fatherhood with your dad.
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Heyneke Meyer described the Springboks' conversion rate in the opposition's 22m as 'unacceptable' and has demanded greater patience from his team in that zone.
The Springboks have struggled to find a consistent try-scoring groove this season. They started well against England in the second Test of the series in June, and later put five on Australia at Loftus. But those where exceptions to an otherwise uninspiring season on attack.
They haven't wanted for a lack of opportunities though, with statistics showing them to be the leading side in the world this year for time spent in the opposition's 22m. Tellingly, however, they are also high on the list for errors or infringements in that area, which has undermined their cause significantly.
Meyer, speaking in Edinburgh before Saturday's Test against Scotland, appeared to be vexed by this shortcoming and determined to remedy it.
'Against Ireland I thought we should have built an innings more,' he began. 'We tried too many things too early and gave away turnovers.
'That's part of our learning curve, but that said, that was the only game that we didn't win the territory battle. I've been hard on the players about our patience in the goal zone (between the 22m and tryline). The top teams in the world get points when they get in there. It may be a coaching or inexperience thing, but it has to improve. We get in the right areas and we get clean ball, but we don't covert. At this level that is unacceptable.'
The All Blacks ran in six tries against Scotland on Sunday, but, in addition to the world champions' superior patience, the Springboks don't possess their synergy, skill, invention and flair, and should probably set their sights lower than a return of that scale.
They cannot, however, deliver anything but a dominant defensive display, particularly with Scotland having sounded a warning of their attacking potential with three tries against the Blacks.
'I really believe Scotland is a quality side, they're very dangerous when they keep the ball in hand. The scoreline didn't reflect how close it was,' Meyer said of their host's 51-22 defeat.
'There was 10 minutes of brilliance where the All Blacks put 20 points on them. Scotland were always in the game and scored three tries, which us and Australia never managed to do. They were probably unlucky not to score one or two more. So it's important for us to stay focussed.'
The Springboks have defended well to date, conceding an average of 1.2 tries per match and will want to continue to improve on this important facet of play.
'I've said that attack puts bums on seats but defence wins trophies. There was an emphasis on getting that right last week after the All Blacks game in Soweto. Ireland put us under pressure and we responded really well. We'll have to be on top of our game to shut down Scotland.'


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Results vs. Ferris State (2009-03-12 00:00:00)
March 12, 2009Misenheimer, NC – The Pfeiffer men's and women's tennis teams fell in a dual match against Ferris State on Thursday afternoon. The men lost the non-conference meet 9-0, while the women fell 9-0. Both the men's and women's teams' records rest at 4-5 overall.
The Pfeiffer men fought hard against FSU, but came up one match short. FSU swept in the doubles matches, but Pfeiffer won four of six singles matches. Philip Lawson (Johannesburg, South Africa) was victorious in the number one position (6-1, 6-2). Johan deWit (Windhoek, Namibia) won 6-3, 7-6 at number two and AJ Flores (Atlanta, GA) went into an extra set to win 6-2, 6-7, 6-4 at number three. Cody Simpson (Dobson, NC) also brought home a win in the sixth position (3-6, 6-3, 10-7).
The Pfeiffer women put up a strong fight as well, but unfortunately were swept in all matches. In the number one match Patty Dominguez (Caracas, Venezuela) pushed through her first set 7-6, but lost 6-3 in the second. Catie Thomas (Asheboro, NC) battled to a 6-4, 6-1 loss at the number two position.Pfeiffer v. Ferris State 3/12/09 Doubles Dominguez/Billeter v. Ingle/Diorio - FSU 8-1 Thomas/Huffaker v. Prisner/Conklin - FSU 8-4 Dickens/Carpenter v. Flowers/Coleman - FSU 8-1 Singles Dominguez v. Ingle - FSU 7-6, 6-3 Thomas v. Flowers - FSU 6-4, 6-1 Carpenter v. Diorio - FSU 6-0, 6-1 Billeter v. Prisner - FSU 6-1, 6-1 Huffaker v. Conklin -FSU 6-0, 6-1 Dickens v. Coleman - FSU 6-1, 6-0