Study of EG-1962 Compared to Standard of Care Oral Nimodipine in Adults With Aneurysmal Subarachnoid Hemorrhage (NEWTON2)
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| ClinicalTrials.gov Identifier: NCT02790632 |
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Recruitment Status :
Terminated
(DMC review concluded study has a low probability of meeting its primary endpoint)
First Posted : June 6, 2016
Last Update Posted : July 25, 2018
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Sponsor:
Edge Therapeutics Inc
Information provided by (Responsible Party):
Edge Therapeutics Inc
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Brief Summary:
This study compares EG-1962 to enteral nimodipine in the treatment of aneurysmal subarachnoid hemorrhage.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Subarachnoid Hemorrhage, Aneurysmal | Drug: EG-1962 (nimodipine microparticles) Drug: Enteral Nimodipine | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 374 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy and Safety Study Comparing EG-1962 to Standard of Care Oral Nimodipine in Adults With Aneurysmal Subarachnoid Hemorrhage |
| Study Start Date : | July 2016 |
| Actual Primary Completion Date : | June 2018 |
| Actual Study Completion Date : | June 2018 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Bleeding
Drug Information available for:
Nimodipine
| Arm | Intervention/treatment |
|---|---|
Experimental: EG-1962 Group
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Drug: EG-1962 (nimodipine microparticles)
Single intraventricular administration of EG-1962 via EVD and placebo capsules or tablets administered for up to 21 days |
Active Comparator: Enteral Nimodipine Group
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Drug: Enteral Nimodipine
Enteral Nimodipine capsules or tablets administered for up to 21 days and single intraventricular administration of saline via EVD |
Primary Outcome Measures :
- Proportion of subjects with a favorable outcome measured on the Extended Glasgow Outcome Scale [Primary Efficacy Endpoint] [ Time Frame: 90 Days ]Proportion of subjects with a favorable outcome measured on the Extended Glasgow Outcome Scale (GOSE) at Day 90
Secondary Outcome Measures :
- Proportion of subjects with favorable neurocognitive outcome measured by the Montreal Cognitive Assessment [Secondary Efficacy Endpoint] [ Time Frame: 90 Days ]Proportion of subjects with favorable neurocognitive outcome measured by the Montreal Cognitive Assessment (MoCA) at Day 90
Other Outcome Measures:
- Adverse Events [ Time Frame: 90 Days ]Incidence and severity of adverse events in EG-1962 treated subjects compared to subjects treated with standard of care oral nimodipine
- Delayed Cerebral Infarction [ Time Frame: 30 Days ]Proportion of subjects with delayed cerebral infarction present on CT scan at Day 30
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| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Ruptured saccular aneurysm confirmed by angiography and repaired by neurosurgical clipping or endovascular coiling
- External ventricular drain in place
- Subarachnoid hemorrhage on computed tomography (CT) scan of grade 2-4 on the modified Fisher scale
- WFNS grade 2, 3, or 4
Exclusion Criteria:
- Major complication during aneurysm repair such as, but not limited to, massive intraoperative hemorrhage, brain swelling, arterial occlusion or inability to secure the ruptured aneurysm
- Angiographic vasospasm prior to randomization
- Evidence of a cerebral infarction with neurological deficit
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02790632
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Sponsors and Collaborators
Edge Therapeutics Inc
Investigators
| Study Chair: | R. Loch Macdonald, MD, PhD | Edge Therapeutics Inc |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Edge Therapeutics Inc |
| ClinicalTrials.gov Identifier: | NCT02790632 History of Changes |
| Other Study ID Numbers: |
EG-01-1962-03 |
| First Posted: | June 6, 2016 Key Record Dates |
| Last Update Posted: | July 25, 2018 |
| Last Verified: | July 2018 |
Keywords provided by Edge Therapeutics Inc:
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Aneurysm, Ruptured Nimodipine Subarachnoid Hemorrhage |
Additional relevant MeSH terms:
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Hemorrhage Subarachnoid Hemorrhage Pathologic Processes Intracranial Hemorrhages Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Vascular Diseases Cardiovascular Diseases Nimodipine Antihypertensive Agents Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Vasodilator Agents |