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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02790632




Registration number
NCT02790632
Ethics application status
Date submitted
26/05/2016
Date registered
6/06/2016
Date last updated
26/07/2018

Titles & IDs
Public title
Study of EG-1962 Compared to Standard of Care Oral Nimodipine in Adults With Aneurysmal Subarachnoid Hemorrhage
Scientific 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
Secondary ID [1] 0 0
EG-01-1962-03
Universal Trial Number (UTN)
Trial acronym
NEWTON2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Subarachnoid Hemorrhage, Aneurysmal 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - EG-1962 (nimodipine microparticles)
Treatment: Drugs - Enteral Nimodipine

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

Active comparator: Enteral Nimodipine Group - * 1 dose of intraventricular normal saline
* Up to 21 days of oral nimodipine capsules/tablets


Treatment: Drugs: EG-1962 (nimodipine microparticles)
Single intraventricular administration of EG-1962 via EVD and placebo capsules or tablets administered for up to 21 days

Treatment: Drugs: Enteral Nimodipine
Enteral Nimodipine capsules or tablets administered for up to 21 days and single intraventricular administration of saline via EVD
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of subjects with a favorable outcome measured on the Extended Glasgow Outcome Scale [Primary Efficacy Endpoint]
Timepoint [1] 0 0
90 Days
Secondary outcome [1] 0 0
Proportion of subjects with favorable neurocognitive outcome measured by the Montreal Cognitive Assessment [Secondary Efficacy Endpoint]
Timepoint [1] 0 0
90 Days

Eligibility
Key inclusion criteria
1. Ruptured saccular aneurysm confirmed by angiography and repaired by neurosurgical clipping or endovascular coiling
2. External ventricular drain in place
3. Subarachnoid hemorrhage on computed tomography (CT) scan of grade 2-4 on the modified Fisher scale
4. WFNS grade 2, 3, or 4
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. 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
2. Angiographic vasospasm prior to randomization
3. Evidence of a cerebral infarction with neurological deficit

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2018
Sample size
Target
374
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Nepean Hospital - Kingswood
Recruitment hospital [3] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
02747 - Kingswood
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Kansas
Country [8] 0 0
United States of America
State/province [8] 0 0
Kentucky
Country [9] 0 0
United States of America
State/province [9] 0 0
Maryland
Country [10] 0 0
United States of America
State/province [10] 0 0
Massachusetts
Country [11] 0 0
United States of America
State/province [11] 0 0
Michigan
Country [12] 0 0
United States of America
State/province [12] 0 0
New Jersey
Country [13] 0 0
United States of America
State/province [13] 0 0
New Mexico
Country [14] 0 0
United States of America
State/province [14] 0 0
New York
Country [15] 0 0
United States of America
State/province [15] 0 0
North Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Ohio
Country [17] 0 0
United States of America
State/province [17] 0 0
Oregon
Country [18] 0 0
United States of America
State/province [18] 0 0
Pennsylvania
Country [19] 0 0
United States of America
State/province [19] 0 0
South Carolina
Country [20] 0 0
United States of America
State/province [20] 0 0
Tennessee
Country [21] 0 0
United States of America
State/province [21] 0 0
Virginia
Country [22] 0 0
United States of America
State/province [22] 0 0
Washington
Country [23] 0 0
Austria
State/province [23] 0 0
Innsbruck
Country [24] 0 0
Canada
State/province [24] 0 0
Alberta
Country [25] 0 0
Canada
State/province [25] 0 0
British Columbia
Country [26] 0 0
Canada
State/province [26] 0 0
Ontario
Country [27] 0 0
Canada
State/province [27] 0 0
Quebec
Country [28] 0 0
Canada
State/province [28] 0 0
Saskatchewan
Country [29] 0 0
Czechia
State/province [29] 0 0
Hradec Kralov
Country [30] 0 0
Czechia
State/province [30] 0 0
South Moravian Region
Country [31] 0 0
Czechia
State/province [31] 0 0
Ostrava
Country [32] 0 0
Czechia
State/province [32] 0 0
Prague
Country [33] 0 0
Finland
State/province [33] 0 0
Pirkanmaa
Country [34] 0 0
Finland
State/province [34] 0 0
Helsinki
Country [35] 0 0
Germany
State/province [35] 0 0
Berlin
Country [36] 0 0
Germany
State/province [36] 0 0
Erlangen
Country [37] 0 0
Germany
State/province [37] 0 0
Essen
Country [38] 0 0
Germany
State/province [38] 0 0
Frankfurt am Main
Country [39] 0 0
Germany
State/province [39] 0 0
Hamburg
Country [40] 0 0
Germany
State/province [40] 0 0
Heidelberg
Country [41] 0 0
Germany
State/province [41] 0 0
Köln
Country [42] 0 0
Germany
State/province [42] 0 0
Leipzig
Country [43] 0 0
Germany
State/province [43] 0 0
Mannheim
Country [44] 0 0
Germany
State/province [44] 0 0
Munchen
Country [45] 0 0
Germany
State/province [45] 0 0
Würzburg
Country [46] 0 0
Hong Kong
State/province [46] 0 0
Hong Kong
Country [47] 0 0
Hong Kong
State/province [47] 0 0
New Kowloon
Country [48] 0 0
Israel
State/province [48] 0 0
Petah-Tikva
Country [49] 0 0
Israel
State/province [49] 0 0
Haifa
Country [50] 0 0
Israel
State/province [50] 0 0
Jerusalem
Country [51] 0 0
Israel
State/province [51] 0 0
Ramat Gan
Country [52] 0 0
New Zealand
State/province [52] 0 0
Auckland
Country [53] 0 0
Singapore
State/province [53] 0 0
Singapore

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Edge Therapeutics Inc
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study compares EG-1962 to enteral nimodipine in the treatment of aneurysmal subarachnoid hemorrhage.
Trial website
https://clinicaltrials.gov/study/NCT02790632
Trial related presentations / 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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
R. Loch Macdonald, MD, PhD
Address 0 0
Edge Therapeutics Inc
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02790632