Rate of Enrollment
Primary
· Day 1
The number of months to enroll 10 participants.
| Group | Value | 95% CI |
|---|---|---|
| RP-1127 (Glyburide for Injection) | 9.6 |
Last reviewed · How we verify
NCT01268683: GAMES-PILOT
Glyburide Advantage in Malignant Edema and Stroke Pilot
Completed
Phase 1, PHASE2
Results posted
Last updated 22 November 2024
What this trial tests
Phase 1, PHASE2 trial testing Glyburide for Injection in Ischemic Stroke in 10 participants. Completed in 7 June 2012.
Timeline
26 May 2011
Primary endpoint
7 June 2012
7 June 2012
7 June 2012
Quick facts
| Lead sponsor | Remedy Pharmaceuticals, Inc. |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 10 |
| Start date | 26 May 2011 |
| Primary completion | 7 June 2012 |
| Estimated completion | 7 June 2012 |
| Sites | 4 locations across United States |
Drugs / interventions tested
- Glyburide for Injection — full drug profile →
Conditions studied
- Ischemic Stroke — all drugs for Ischemic Stroke →
Sponsor
Remedy Pharmaceuticals, Inc. — full company profile →
Who can join
Adults 18 to 80, any sex, with Ischemic Stroke. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Enrolled Participants to Screened Participants
Primary
· Day 1
| Group | Value | 95% CI |
|---|---|---|
| RP-1127 (Glyburide for Injection) | 5.7 |
Percentage of Participants Completing 90-Day Follow-Up
Primary
· Day 90
| Group | Value | 95% CI |
|---|---|---|
| RP-1127 (Glyburide for Injection) | 80 |
Percentage of Dose Reductions/ Dose Suspensions
Primary
· Up to Day 3
| Group | Value | 95% CI |
|---|---|---|
| RP-1127 (Glyburide for Injection) | 0 |
Percentage of Participants With All Four MRI Assessments Per Protocol
Primary
· Up to Day 3
| Group | Value | 95% CI |
|---|---|---|
| RP-1127 (Glyburide for Injection) | 90 |
Number of MRI Assessments Per Participant
Primary
· Up to Day 3
| Group | Value | 95% CI |
|---|---|---|
| RP-1127 (Glyburide for Injection) | 3.9 | 3 – 4 |
Percentage of Participants Requiring One or More Hypoglycemia Treatments
Primary
· Up to Day 4
| Group | Value | 95% CI |
|---|---|---|
| RP-1127 (Glyburide for Injection) | 0 |
Percentage of Participants With Pre-specified Adverse Events Associated With Glyburide According to Protocol
Primary
· Up to Day 4
| Group | Value | 95% CI |
|---|---|---|
| RP-1127 (Glyburide for Injection) | 0 |
Number of Participants With Adverse Events and Serious Adverse Events
Secondary
· Up to Day 90
Adverse Events (AE's) of special interest (cardiac events, difficulty controlling blood sugar, liver problems, and blood disorders, including anemia) will be followed for 30 days and all Severe Adverse Events (SAE's) will be followed for 90 days. SAE's and AE's were reviewed, and the number of participants with unanticipated adverse events, or drug-related SAE's were assessed.
Adverse Events
| Group | Value | 95% CI |
|---|---|---|
| RP-1127 (Glyburide for Injection) | 10 |
Serious Adverse Events
| Group | Value | 95% CI |
|---|---|---|
| RP-1127 (Glyburide for Injection) | 3 |
Infarcted Hemisphere Volume
Secondary
· Baseline, Day 1, Day 2, and Day 3
Baseline
| Group | Value | 95% CI |
|---|---|---|
| RP-1127 (Glyburide for Injection) | 135.20 | ± 27.19 |
Day 1
| Group | Value | 95% CI |
|---|---|---|
| RP-1127 (Glyburide for Injection) | 156.78 | ± 35.09 |
Day 2
| Group | Value | 95% CI |
|---|---|---|
| RP-1127 (Glyburide for Injection) | 165.38 | ± 34.17 |
Day 3
| Group | Value | 95% CI |
|---|---|---|
| RP-1127 (Glyburide for Injection) | 181.71 | ± 33.90 |
Absolute Diffusion Weighted Imaging (DWI) Lesion Volume
Secondary
· Baseline, Day 1, Day 2, and Day 3
Baseline
| Group | Value | 95% CI |
|---|---|---|
| RP-1127 (Glyburide for Injection) | 101.76 | ± 22.57 |
Day 1
| Group | Value | 95% CI |
|---|---|---|
| RP-1127 (Glyburide for Injection) | 141.62 | ± 44.05 |
Day 2
| Group | Value | 95% CI |
|---|---|---|
| RP-1127 (Glyburide for Injection) | 152.31 | ± 49.26 |
Day 3
| Group | Value | 95% CI |
|---|---|---|
| RP-1127 (Glyburide for Injection) | 169.73 | ± 54.28 |
Change From Baseline in DWI Lesion Volume
Secondary
· Baseline, Day 1, Day 2, and Day 3 (Day 3 reported)
| Group | Value | 95% CI |
|---|---|---|
| RP-1127 (Glyburide for Injection) | 60.30 | ± 41.37 |
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to 90 Days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
RP-1127 (Glyburide for Injection)
Serious: 3/10 (30%)
Deaths: 1/10
Serious adverse events (5 terms)
| Reaction | System | RP-1127 (Glyburide for Inj… |
|---|---|---|
| Brain herniation | Nervous system disorders | — |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | — |
| Cerebrovascular accident | Nervous system disorders | — |
| Dehydration | Metabolism and nutrition disorders | — |
| Hypotension | Vascular disorders | — |
Other adverse events (44 terms — click to expand)
| Reaction | System | RP-1127 (Glyburide for Inj… |
|---|---|---|
| Hypomagnesemia | Metabolism and nutrition disorders | — |
| Hypokalaemia | Metabolism and nutrition disorders | — |
| Hypocalcemia | Metabolism and nutrition disorders | — |
| Pain | General disorders | — |
| Anxiety | Psychiatric disorders | — |
| Hypophosphatemia | Metabolism and nutrition disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Urinary tract infection | Infections and infestations | — |
| Agitation | Nervous system disorders | — |
| Hyponatremia | Metabolism and nutrition disorders | — |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | — |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | — |
| Constipation | Gastrointestinal disorders | — |
| Hypertension | Vascular disorders | — |
| Fluid overload | Metabolism and nutrition disorders | — |
| Cerebral haemorrhage | Nervous system disorders | — |
| Brain herniation | Nervous system disorders | — |
| Alcohol withdrawal syndrome | Psychiatric disorders | — |
| Staphylococcal bacteraemia | Infections and infestations | — |
| Depression | Psychiatric disorders | — |
| Blood glucose decreased | Investigations | — |
| Dry eyes | Eye disorders | — |
| Dry mouth | Gastrointestinal disorders | — |
| Dysphagia | Gastrointestinal disorders | — |
| Headache | Nervous system disorders | — |
| Hyperkalemia | Metabolism and nutrition disorders | — |
| Hypercalcaemia | Endocrine disorders | — |
| Insomnia | Nervous system disorders | — |
| Malnutrition | Metabolism and nutrition disorders | — |
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | — |
| Wheezing | Respiratory, thoracic and mediastinal disorders | — |
| Pyrexia | General disorders | — |
| Transaminase increased | Investigations | — |
| Hypovitaminosis | Metabolism and nutrition disorders | — |
| Agitation | Psychiatric disorders | — |
| Acute myocardial infarction | Cardiac disorders | — |
| Vision blurred | Nervous system disorders | — |
| Renal failure chronic | Renal and urinary disorders | — |
| Open wound | Injury, poisoning and procedural complications | — |
| Dehydration | Metabolism and nutrition disorders | — |
Most-reported serious reactions: Brain herniation, Respiratory failure, Cerebrovascular accident, Dehydration, Hypotension.
Data from ClinicalTrials.gov NCT01268683 adverse events section.
Sponsor's own description
The primary objective of this study is to assess the feasibility of enrolling, evaluating, and treating with glyburide for injection severe anterior circulation ischemic stroke participants, whether or not treated with standard of care intravenous (IV) recombinant tissue plasminogen activator (rtPA). Participants must be between 18-80 years of age, must have a baseline diffusion weighted image (DWI) lesion volume 82 -210 centimeters cubed (cm3), and time from symptom onset to start of study infusion must be ≤10 hour(hr). The secondary objectives are to assess the initial safety and tolerability, and pharmacokinetics (PK) /pharmacodynamics (PD) of glyburide in severe stroke participants, as well as to compare the clinical and magnetic resonance imaging (MRI) outcome data to benchmark data derived from published literature.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Inflammasomes in neuroinflammatory and neurodegenerative diseases.
Voet S, Srinivasan S, Lamkanfi M, van Loo G. · · 2019 · cited 548× · PMID 31015277 · DOI 10.15252/emmm.201810248 -
Pharmacotherapy of traumatic brain injury: state of the science and the road forward: report of the Department of Defense Neurotrauma Pharmacology Workgroup.
Diaz-Arrastia R, Kochanek PM, Bergold P, Kenney K, et al · · 2014 · cited 205× · PMID 23968241 · DOI 10.1089/neu.2013.3019 -
Sulfonylurea receptor 1 in central nervous system injury: a focused review.
Simard JM, Woo SK, Schwartzbauer GT, Gerzanich V. · · 2012 · cited 146× · PMID 22714048 · DOI 10.1038/jcbfm.2012.91 -
Novel treatment targets for cerebral edema.
Walcott BP, Kahle KT, Simard JM. · · 2012 · cited 100× · PMID 22125096 · DOI 10.1007/s13311-011-0087-4 -
Pilot study of intravenous glyburide in patients with a large ischemic stroke.
Sheth KN, Kimberly WT, Elm JJ, Kent TA, et al · · 2014 · cited 77× · PMID 24193798 · DOI 10.1161/strokeaha.113.003352 -
Glyburide is associated with attenuated vasogenic edema in stroke patients.
Kimberly WT, Battey TW, Pham L, Wu O, et al · · 2014 · cited 76× · PMID 24072459 · DOI 10.1007/s12028-013-9917-z -
Cerebral edema after ischemic stroke: Pathophysiology and underlying mechanisms.
Gu Y, Zhou C, Piao Z, Yuan H, et al · · 2022 · cited 69× · PMID 36061592 · DOI 10.3389/fnins.2022.988283 -
Disruption of ion homeostasis in the neurogliovascular unit underlies the pathogenesis of ischemic cerebral edema.
Khanna A, Kahle KT, Walcott BP, Gerzanich V, et al · · 2014 · cited 69× · PMID 24323726 · DOI 10.1007/s12975-013-0307-9
Verify or expand the search:
- PubMed search for NCT01268683
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Glyburide for Injection
Trials testing the same drug.
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Other recruiting trials for Ischemic Stroke
Currently open trials in the same condition.
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Other Remedy Pharmaceuticals, Inc. trials
Trials by the same sponsor.
- NCT03954041 — A Study to Evaluate the Efficacy and Safety of BIIB093 in Participants With Brain Contusion · Phase 2 · terminated
- NCT02864953 — Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous BIIB093 (Glibenclamide) for Severe Cerebral Edema Follo · Phase 3 · terminated
- NCT01794182 — Glyburide Advantage in Malignant Edema and Stroke - Remedy Pharmaceuticals · Phase 2 · completed
- NCT01454154 — Glyburide (RP-1127) for Traumatic Brain Injury (TBI) · Phase 2 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT01268683 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Remedy Pharmaceuticals, Inc.
- Last refreshed: 22 November 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01268683.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing