Subarachnoid Hemorrhage, AneurysmalPhase 3NEWTON2NCT02790632
Study of EG-1962 Compared to Standard of Care Oral Nimodipine in Adults With Aneurysmal Subarachnoid Hemorrhage
A Phase 3 study testing EG-1962 (nimodipine microparticles) and Enteral Nimodipine in people with Subarachnoid Hemorrhage, Aneurysmal, run by Edge Therapeutics Inc at 79 sites in 11 countries.
Trial summary
This study compares EG-1962 to enteral nimodipine in the treatment of aneurysmal subarachnoid hemorrhage. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Subarachnoid Hemorrhage, Aneurysmal
- What is being tested?
- EG-1962 (nimodipine microparticles) and Enteral Nimodipine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 374 participants
- Where
- 79 sitesin 11 countries
- Study dates
- Jul 2016to Jun 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
79 sites in 11 countries.
79 sites in 11 countries
United States45 sites
University of New Mexico Hospital
Albuquerque, New Mexico, 87131
University of Maryland Medical Systems
Baltimore, Maryland, 21201
University of Alabama at Birmingham Hospital
Birmingham, Alabama, 35233
Massachusetts General Hospital
Boston, Massachusetts, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
UNC Hospitals Neuroscience Intensive Care Unit
Chapel Hill, North Carolina, 27599
Medical University of South Carolina
Charleston Air Force Base, South Carolina, 29425
Northwestern Memorial Hospital
Chicago, Illinois, 60611
University of Illinois Hospital and Health Sciences System
Chicago, Illinois, 60612-7232
Rush University Medical Center
Chicago, Illinois, 60612
University Hospitals Case Medical Center
Cleveland, Ohio, 44106
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Henry Ford Hospital
Detroit, Michigan, 48202
Duke University Medical Pavilion
Durham, North Carolina, 27710
Inova Fairfax Medical Campus
Falls Church, Virginia, 22042
University of California, San Francisco-Fresno
Fresno, California, 93701
UF Health Shands Florida
Gainesville, Florida, 32610
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Baptist Medical Center/Lyerly Neurosurgery
Jacksonville, Florida, 32207
Mayo Clinic Florida
Jacksonville, Florida, 32224
University of Kansas Medical Center
Kansas City, Kansas, 66160
University of Kentucky Medical Center
Lexington, Kentucky, 40536
Keck Hospital of USC
Los Angeles, California, 90033
Cedars-Sinai Medical Center
Los Angeles, California, 90048
David Geffen School of Medicine at UCLA
Los Angeles, California, 90095
University of Louisville Hospital
Louisville, Kentucky, 40202
North Shore University Hospital
Manhasset, New York, 11030
Semmes Murphey Neurological Clinic
Memphis, Tennessee, 38120
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08901
Yale New Haven Hospital (YNHH)
New Haven, Connecticut, 06510
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Lenox Hill Hospital
New York, New York, 10075
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Jefferson Hospital for Neuroscience
Philadelphia, Pennsylvania, 19107
Dignity Health; St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, 15213
Providence St. Vincent Medical Center
Portland, Oregon, 97225
Oregon Health and Science University
Portland, Oregon, 97239
VCU Medical Center
Richmond, Virginia, 23298
University of Rochester Medical Center
Rochester, New York, 14642
UCSF
San Francisco, California, 94143
University of Washington, Harborview Medical Center
Seattle, Washington, 98104
Tallahassee Neurological Clinic
Tallahassee, Florida, 32308
Montefiore Medical Center
The Bronx, New York, 10467
Germany11 sites
Neuro Intensive Care Unit 102i; Campus Charite Mitte (CCM)
Berlin, 10117
Zentrum fur Neurochirurgie der Uniklinik Koln
Cologne, 50937
Universitatsklinikum Erlangen, Neurologische Klinik, Koptkliniken
Erlangen, 91054
Klinik für Neurochirurgie des Universitätsklinikum Essen
Essen, 45147
Klinik für Neurochirurgie, Zentrum der Neurologie und Neurochirurgie, Goethe-Universitätsklinikum Frankfurt am Main
Frankfurt am Main, 60528
Universitätsklinikum Hamburg Eppendorf, Klinik und Poliklinik für Neurochirurgie, Neues Klinikum
Hamburg, 20246
Neurochirurgische Klinik der Universität Heidelberg
Heidelberg, 69120
Klinik und Poliklinik für Neurochirurgie des Universitatsklinikum Leipzig
Leipzig, 04013
Neurochirurgische Klinik, Universitatsmedizin Mannheim, Universität Heidelberg
Mannheim, 68167
Neurochirurgische Klinik und Poliklinik, Klinikum rechts der Isar der Technischen Universitat Munchen
München, 81675
Neutochirurgische Klinik und Poliklinik des Universitatsklinikum Wurzburg
Würzburg, 97080
Canada5 sites
University of Alberta Hospital/Mackenzie Health Sciences Centre
Edmonton, Alberta, T6G 2B7
Centre Hospitalier de l'Universite de Montreal (CHUM), Hopital Notre Dame
Montreal, Quebec, H2L 4M1
Royal University Hospital
Saskatoon, Saskatchewan, S7N 0W8
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
Vancouver General Hospital
Vancouver, British Columbia, V5Z1M9
Czechia4 sites
Faculty Hospital Brno
Brno, South Moravian, 62500
Faculty Hospital Hradec Kralove
Hradec Králové, Hradec Kralov, 50005
Faculty Hospital Ostrava
Ostrava, 708 52
Military University Hospital Prague
Prague, 16902
Israel4 sites
Rambam Health Care Center
Haifa, 3109606
Hadassah Hebrew University Medical Center
Jerusalem, 91120
Rabin Medical Center
Petah Tikva, Petah-Tikva, 4941492
Sheba Medical Center
Ramat Gan
Australia3 sites
Royal Adelaide Hospital
Adelaide, 5000
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050
Nepean Hospital
Kingswood, New South Wales, 02747
Finland2 sites
Helsinki University Hospital
Helsinki, 00260
Tampere University Hospital
Tampere, Pirkanmaa, 33521
Hong Kong2 sites
Queen Mary Hospital
Hong Kong
Prince of Wales Hospital
New Kowloon
Austria1 site
Medizinische Universitat Innsbruck/Tirol Universitatsklinik fur Neurologie
Innsbruck, 06020
About this study
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
This study compares EG-1962 to enteral nimodipine in the treatment of aneurysmal subarachnoid hemorrhage.
- Conditions
- Subarachnoid Hemorrhage, Aneurysmal
- Being tested
- EG-1962 (nimodipine microparticles), Enteral Nimodipine
- Keywords
- Aneurysm, Ruptured, Nimodipine, Subarachnoid Hemorrhage
- Medical subject headings
- Subarachnoid Hemorrhage, Aneurysm, Ruptured
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EG-1962 (nimodipine microparticles)Drug
Single intraventricular administration of EG-1962 via EVD and placebo capsules or tablets administered for up to 21 days
Enteral NimodipineDrug
Enteral Nimodipine capsules or tablets administered for up to 21 days and single intraventricular administration of saline via EVD
| Study group | Role | What they receive |
|---|---|---|
| EG-1962 Group | Experimental | * 1 dose of intraventricular EG-1962 (nimodipine microparticles) 600 mg
* Up to 21 days of placebo capsules/tablets Receives: Drug: EG-1962 (nimodipine microparticles) |
| Enteral Nimodipine Group | Active comparator | * 1 dose of intraventricular normal saline
* Up to 21 days of oral nimodipine capsules/tablets Receives: Drug: Enteral Nimodipine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with a favorable outcome measured on the Extended Glasgow Outcome Scale [Primary Efficacy Endpoint]
Proportion of subjects with a favorable outcome measured on the Extended Glasgow Outcome Scale (GOSE) at Day 90
Measured: 90 Days
Secondary outcomes (1)
Proportion of subjects with favorable neurocognitive outcome measured by the Montreal Cognitive Assessment [Secondary Efficacy Endpoint]
Proportion of subjects with favorable neurocognitive outcome measured by the Montreal Cognitive Assessment (MoCA) at Day 90
Measured: 90 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2016 (estimated)
- Study startJul 2016
- Primary completionJun 2018
- Study completionJun 2018
Why it stopped: DMC review concluded study has a low probability of meeting its primary endpoint
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Subarachnoid Hemorrhage, AneurysmalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 374 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Edge Therapeutics Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- R. Loch Macdonald, MD, PhD, Study chair, Edge Therapeutics Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02790632
- Sponsor's protocol ID
- EG-01-1962-03
- Acronym
- NEWTON2
- Status last verified
- Jul 2018
- First submitted
- 26 May 2016
- Last updated
- 26 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Carlson AP, Hanggi D, Wong GK, Etminan N, Mayer SA, Aldrich F, Diringer MN, Schmutzhard E, Faleck HJ, Ng D, Saville BR, Bleck T, Grubb R Jr, Miller M, Suarez JI, Proskin HM, Macdonald RL; NEWTON Investigators. Single-Dose Intraventricular Nimodipine Microparticles Versus Oral Nimodipine for Aneurysmal Subarachnoid Hemorrhage. Stroke. 2020 Apr;51(4):1142-1149. doi: 10.1161/STROKEAHA.119.027396. Epub 2020 Mar 6.
PubMed 32138631Hanggi D, Etminan N, Mayer SA, Aldrich EF, Diringer MN, Schmutzhard E, Faleck HJ, Ng D, Saville BR, Macdonald RL; NEWTON Investigators. Clinical Trial Protocol: 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 [NEWTON-2 (Nimodipine Microparticles to Enhance Recovery While Reducing TOxicity After SubarachNoid Hemorrhage)]. Neurocrit Care. 2019 Feb;30(1):88-97. doi: 10.1007/s12028-018-0575-z.
PubMed 30014184
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02790632
- Acronym / sponsor ID
- NEWTON2 / EG-01-1962-03
- Conditions
- Subarachnoid Hemorrhage, Aneurysmal
- Keywords
- Aneurysm, Ruptured, Nimodipine, Subarachnoid Hemorrhage
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: DMC review concluded study has a low probability of meeting its primary endpoint
- Enrolment
- 374 participants (estimated)
- Lead sponsor
- Edge Therapeutics IncIndustry (pharma, biotech, devices)
- Study start
- Jul 2016
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 6 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study compares EG-1962 to enteral nimodipine in the treatment of aneurysmal subarachnoid hemorrhage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EG-1962 Group | Experimental | Drug: EG-1962 (nimodipine microparticles)* 1 dose of intraventricular EG-1962 (nimodipine microparticles) 600 mg * Up to 21 days of placebo capsules/tablets |
| Enteral Nimodipine Group | Active comparator | Drug: Enteral Nimodipine* 1 dose of intraventricular normal saline * Up to 21 days of oral nimodipine capsules/tablets |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EG-1962 (nimodipine microparticles)Single intraventricular administration of EG-1962 via EVD and placebo capsules or tablets administered for up to 21 days | Drug | EG-1962 Group |
| Enteral NimodipineEnteral Nimodipine capsules or tablets administered for up to 21 days and single intraventricular administration of saline via EVD | Drug | Enteral Nimodipine Group |
Primary outcome
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
1 secondary outcome
Proportion of subjects with favorable neurocognitive outcome measured by the Montreal Cognitive Assessment [Secondary Efficacy Endpoint]
Time frame: 90 Days
Results and safety
The study was stopped early (reason given: DMC review concluded study has a low probability of meeting its primary endpoint). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2018.
- Derived from this study: PubMed 32138631Carlson AP, Hanggi D, Wong GK, Etminan N, Mayer SA, Aldrich F, Diringer MN, Schmutzhard E, Faleck HJ, Ng D, Saville BR, Bleck T, Grubb R Jr, Miller M, Suarez JI, Proskin HM, Macdonald RL; NEWTON Investigators. Single-Dose Intraventricular Nimodipine Microparticles Versus Oral Nimodipine for Aneurysmal Subarachnoid Hemorrhage. Stroke. 2020 Apr;51(4):1142-1149. doi: 10.1161/STROKEAHA.119.027396. Epub 2020 Mar 6.
- Derived from this study: PubMed 30014184Hanggi D, Etminan N, Mayer SA, Aldrich EF, Diringer MN, Schmutzhard E, Faleck HJ, Ng D, Saville BR, Macdonald RL; NEWTON Investigators. Clinical Trial Protocol: 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 [NEWTON-2 (Nimodipine Microparticles to Enhance Recovery While Reducing TOxicity After SubarachNoid Hemorrhage)]. Neurocrit Care. 2019 Feb;30(1):88-97. doi: 10.1007/s12028-018-0575-z.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
R. Loch Macdonald, MD, PhD study chair
Edge Therapeutics Inc
79 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing EG-1962 (nimodipine microparticles) and Enteral Nimodipine in people with Subarachnoid Hemorrhage, Aneurysmal, run by Edge Therapeutics Inc at 79 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 79 sites in United States, Germany, Canada, Czechia, Israel and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: DMC review concluded study has a low probability of meeting its primary endpoint). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects with a favorable outcome measured on the Extended Glasgow Outcome Scale [Primary Efficacy Endpoint] (time frame: 90 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02790632, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2018.