Study of EG-1962 Compared to Standard of Care Oral Nimodipine in Adults With Aneurysmal Subarachnoid Hemorrhage

NCT02790632 | Terminated Phase 3 DMC

• 1 other identifier: EG-01-1962-03
• Study Type: interventional
• Target: 374
• Locations: 10 countries
• Sites: 78

Brief Summary

This study compares EG-1962 to enteral nimodipine in the treatment of aneurysmal subarachnoid hemorrhage.

Conditions

Subarachnoid Hemorrhage, Aneurysmal

Keywords

Aneurysm, Ruptured; Nimodipine; Subarachnoid Hemorrhage

Outcome Measures

Primary Outcomes (1)

• 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

  90 Days

Secondary Outcomes (1)

• Proportion of subjects with favorable neurocognitive outcome measured by the Montreal Cognitive Assessment [Secondary Efficacy Endpoint]

  90 Days

Other Outcomes (2)

• Adverse Events

  90 Days

• Delayed Cerebral Infarction

  30 Days

Study Arms (2)

EG-1962 Group

EXPERIMENTAL

* 1 dose of intraventricular EG-1962 (nimodipine microparticles) 600 mg * Up to 21 days of placebo capsules/tablets

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

Drug: Enteral Nimodipine

Interventions

EG-1962 (nimodipine microparticles) DRUG

Single intraventricular administration of EG-1962 via EVD and placebo capsules or tablets administered for up to 21 days

EG-1962 Group

Enteral Nimodipine DRUG

Enteral Nimodipine capsules or tablets administered for up to 21 days and single intraventricular administration of saline via EVD

Enteral Nimodipine Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Edge Therapeutics Inc: lead

Study Sites (79)

University of Alabama at Birmingham Hospital

Birmingham, Alabama, 35233, United States

Location

Dignity Health; St. Joseph's Hospital and Medical Center

Phoenix, Arizona, 85013, United States

Location

University of California, San Francisco-Fresno

Fresno, California, 93701, United States

Location

Keck Hospital of USC

Los Angeles, California, 90033, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

David Geffen School of Medicine at UCLA

Los Angeles, California, 90095, United States

Location

UCSF

San Francisco, California, 94143, United States

Location

Yale New Haven Hospital (YNHH)

New Haven, Connecticut, 06510, United States

Location

UF Health Shands Florida

Gainesville, Florida, 32610, United States

Location

Baptist Medical Center/Lyerly Neurosurgery

Jacksonville, Florida, 32207, United States

Location

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

Location

Tallahassee Neurological Clinic

Tallahassee, Florida, 32308, United States

Location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

University of Illinois Hospital and Health Sciences System

Chicago, Illinois, 60612-7232, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

University of Kentucky Medical Center

Lexington, Kentucky, 40536, United States

Location

University of Louisville Hospital

Louisville, Kentucky, 40202, United States

Location

University of Maryland Medical Systems

Baltimore, Maryland, 21201, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Robert Wood Johnson University Hospital

New Brunswick, New Jersey, 08901, United States

Location

University of New Mexico Hospital

Albuquerque, New Mexico, 87131, United States

Location

North Shore University Hospital

Manhasset, New York, 11030, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Lenox Hill Hospital

New York, New York, 10075, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

UNC Hospitals Neuroscience Intensive Care Unit

Chapel Hill, North Carolina, 27599, United States

Location

Duke University Medical Pavilion

Durham, North Carolina, 27710, United States

Location

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

Providence St. Vincent Medical Center

Portland, Oregon, 97225, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Jefferson Hospital for Neuroscience

Philadelphia, Pennsylvania, 19107, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

UPMC Presbyterian Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

Medical University of South Carolina

Charleston Air Force Base, South Carolina, 29425, United States

Location

Semmes Murphey Neurological Clinic

Memphis, Tennessee, 38120, United States

Location

Inova Fairfax Medical Campus

Falls Church, Virginia, 22042, United States

Location

VCU Medical Center

Richmond, Virginia, 23298, United States

Location

University of Washington, Harborview Medical Center

Seattle, Washington, 98104, United States

Location

Royal Prince Alfred Hospital

Camperdown, New South Wales, 2050, Australia

Location

Nepean Hospital

Kingswood, New South Wales, 02747, Australia

Location

Royal Adelaide Hospital

Adelaide, 5000, Australia

Location

Medizinische Universitat Innsbruck/Tirol Universitatsklinik fur Neurologie

Innsbruck, 06020, Austria

Location

University of Alberta Hospital/Mackenzie Health Sciences Centre

Edmonton, Alberta, T6G 2B7, Canada

Location

Vancouver General Hospital

Vancouver, British Columbia, V5Z1M9, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Centre Hospitalier de l'Universite de Montreal (CHUM), Hopital Notre Dame

Montreal, Quebec, H2L 4M1, Canada

Location

Royal University Hospital

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

Faculty Hospital Hradec Kralove

Hradec Králové, Hradec Kralov, 50005, Czechia

Location

Faculty Hospital Brno

Brno, South Moravian, 62500, Czechia

Location

Faculty Hospital Ostrava

Ostrava, 708 52, Czechia

Location

Military University Hospital Prague

Prague, 16902, Czechia

Location

Tampere University Hospital

Tampere, Pirkanmaa, 33521, Finland

Location

Helsinki University Hospital

Helsinki, 00260, Finland

Location

Neuro Intensive Care Unit 102i; Campus Charite Mitte (CCM)

Berlin, 10117, Germany

Location

Zentrum fur Neurochirurgie der Uniklinik Koln

Cologne, 50937, Germany

Location

Universitatsklinikum Erlangen, Neurologische Klinik, Koptkliniken

Erlangen, 91054, Germany

Location

Klinik für Neurochirurgie des Universitätsklinikum Essen

Essen, 45147, Germany

Location

Klinik für Neurochirurgie, Zentrum der Neurologie und Neurochirurgie, Goethe-Universitätsklinikum Frankfurt am Main

Frankfurt am Main, 60528, Germany

Location

Universitätsklinikum Hamburg Eppendorf, Klinik und Poliklinik für Neurochirurgie, Neues Klinikum

Hamburg, 20246, Germany

Location

Neurochirurgische Klinik der Universität Heidelberg

Heidelberg, 69120, Germany

Location

Klinik und Poliklinik für Neurochirurgie des Universitatsklinikum Leipzig

Leipzig, 04013, Germany

Location

Neurochirurgische Klinik, Universitatsmedizin Mannheim, Universität Heidelberg

Mannheim, 68167, Germany

Location

Neurochirurgische Klinik und Poliklinik, Klinikum rechts der Isar der Technischen Universitat Munchen

München, 81675, Germany

Location

Neutochirurgische Klinik und Poliklinik des Universitatsklinikum Wurzburg

Würzburg, 97080, Germany

Location

Queen Mary Hospital

Hong Kong, Hong Kong

Location

Prince of Wales Hospital

New Kowloon, Hong Kong

Location

Rabin Medical Center

Petah Tikva, Petah-Tikva, 4941492, Israel

Location

Rambam Health Care Center

Haifa, 3109606, Israel

Location

Hadassah Hebrew University Medical Center

Jerusalem, 91120, Israel

Location

Sheba Medical Center

Ramat Gan, Israel

Location

Auckland City Hospital

Auckland, 1023, New Zealand

Location

National Neuroscience Institute

Singapore, 308433, Singapore

Location

Related Publications (2)

• 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.

  PMID: 32138631 DERIVED

• Hanggi 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.

  PMID: 30014184 DERIVED

MeSH Terms

Conditions

Subarachnoid Hemorrhage; Aneurysm, Ruptured

Interventions

EG-1962

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Aneurysm

Study Officials

• R. Loch Macdonald, MD, PhD

  Edge Therapeutics Inc

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2016
• First Posted: June 6, 2016
• Study Start: July 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: July 26, 2018

Record last verified: 2018-07

Locations

IL (4); DE (11); NZ (1); US (45); HK (2); AU (3); CA (5); SG (1); CZ (4); FI (2)