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NCT02790632: NEWTON2
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
Phase 3 trial testing EG-1962 (nimodipine microparticles) in Subarachnoid Hemorrhage, Aneurysmal in 374 participants. Terminated before completion.
1 June 2018
Quick facts
| Lead sponsor | Edge Therapeutics Inc |
|---|---|
| Phase | Phase 3 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 374 |
| Start date | 1 July 2016 |
| Primary completion | 1 June 2018 |
| Estimated completion | 1 June 2018 |
| Sites | 79 locations across United States, Australia, Austria, Canada, Czechia, Finland, Germany, Hong Kong |
Drugs / interventions tested
- EG-1962 (nimodipine microparticles) — full drug profile →
- Enteral Nimodipine — full drug profile →
Conditions studied
- Subarachnoid Hemorrhage, Aneurysmal — all drugs for Subarachnoid Hemorrhage, Aneurysmal →
Sponsor
Edge Therapeutics Inc — full company profile →
Who can join
Adults 18 to 75, any sex, with Subarachnoid Hemorrhage, Aneurysmal. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
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
Sponsor's own description
This study compares EG-1962 to enteral nimodipine in the treatment of aneurysmal subarachnoid hemorrhage.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
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Nimodipine Reappraised: An Old Drug With a Future.
Carlson AP, Hänggi D, Macdonald RL, Shuttleworth CW. · · 2020 · cited 97× · PMID 31560289 · DOI 10.2174/1570159x17666190927113021 -
Single-Dose Intraventricular Nimodipine Microparticles Versus Oral Nimodipine for Aneurysmal Subarachnoid Hemorrhage.
Carlson AP, Hänggi D, Wong GK, Etminan N, et al · · 2020 · cited 44× · PMID 32138631 · DOI 10.1161/strokeaha.119.027396 -
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
Hänggi D, Etminan N, Mayer SA, Aldrich EF, et al · · 2019 · cited 19× · PMID 30014184 · DOI 10.1007/s12028-018-0575-z -
MEK1/2 inhibitor U0126, but not nimodipine, reduces upregulation of cerebrovascular contractile receptors after subarachnoid haemorrhage in rats.
Christensen ST, Johansson SE, Radziwon-Balicka A, Warfvinge K, et al · · 2019 · cited 11× · PMID 30978262 · DOI 10.1371/journal.pone.0215398
Verify or expand the search:
- PubMed search for NCT02790632
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Subarachnoid Hemorrhage, Aneurysmal
Currently open trials in the same condition.
- NCT04696523 — Effect of Xenon on Brain Injury After Aneurysmal Subarachnoid Hemorrhage · Phase 2 · recruiting
- NCT06819657 — Safety , Feasibility and Preliminary Efficacy of Remote Ischemic Conditioning in Patients With Aneurysmal Subarachnoid H · NA · recruiting
- NCT06766422 — AI Models for Cerebral Aneurysms Segmentation, Detection and Stability Prediction · recruiting
- NCT06906432 — Mechanisms of Brain-Heart Injury of Post-Intracranial Hemorrhage · recruiting
- NCT06218654 — Hemodynamic Instability of Patient With Spontaneous Subarachnoid Hemorrhage · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02790632 (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 Edge Therapeutics Inc
- Last refreshed: 24 July 2018
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/NCT02790632.
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