NCT01893190 (NEWTON) is a Phase 1/Phase 2 clinical trial of Nimodipine in Ruptured Cerebral Aneurysm, sponsored by Edge Therapeutics Inc.

Who is sponsoring NCT01893190?

NCT01893190 is sponsored by Edge Therapeutics Inc.

What drugs are being tested in NCT01893190?

Interventions in NCT01893190: Nimodipine, Nimodipine Microparticles.

What condition does NCT01893190 study?

NCT01893190 studies Ruptured Cerebral Aneurysm, Ruptured Berry Aneurysm.

Is NCT01893190 still recruiting?

NCT01893190 is currently completed. Last updated 31 January 2018.

Last reviewed 2018-01-31 · How we verify

NCT01893190: NEWTON

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Nimodipine Microparticles to Enhance Recovery While Reducing TOxicity After subarachNoid Hemorrhage: Phase I/IIa Multicenter, Controlled, Randomized, Open Label, Dose Escalation, Safety, Tolerability, and Pharmacokinectic Study Comparing EG-1962 and Nimodipine in Patients With Aneurysmal Subarachnoid Hemorrhage

Completed Phase 1/Phase 2 Last updated 31 January 2018

What this trial tests

Phase 1/Phase 2 trial testing Nimodipine in Ruptured Cerebral Aneurysm in 73 participants. Completed in 1 January 2016.

Timeline

1 September 2013

Primary endpoint
1 January 2016

1 January 2016

Quick facts

Lead sponsor	Edge Therapeutics Inc
Phase	Phase 1/Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	73
Start date	1 September 2013
Primary completion	1 January 2016
Estimated completion	1 January 2016
Sites	23 locations across United States, Canada, Czechia, Finland

Drugs / interventions tested

Nimodipine (NIMODIPINE) — full drug profile →
Nimodipine Microparticles — full drug profile →

Conditions studied

Ruptured Cerebral Aneurysm — all drugs for Ruptured Cerebral Aneurysm →
Ruptured Berry Aneurysm — all drugs for Ruptured Berry Aneurysm →

Sponsor

Edge Therapeutics Inc — full company profile →

Who can join

Adults 18 to 75, any sex, with Ruptured Cerebral Aneurysm or Ruptured Berry Aneurysm. 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.

Dose Escalation Period
Time frame: 3 Months
To determine the maximum tolerated dose (MTD) of intraventricular EG 1962.

Sponsor's own description

Phase 1/2a Multicenter, Controlled, Randomized, Open Label, Dose Escalation, Safety, Tolerability, and Pharmacokinetic Study Comparing EG-1962 and Nimodipine in Patients with Aneurysmal Subarachnoid Hemorrhage

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Randomized, Open-Label, Phase 1/2a Study to Determine the Maximum Tolerated Dose of Intraventricular Sustained Release Nimodipine for Subarachnoid Hemorrhage (NEWTON [Nimodipine Microparticles to Enhance Recovery While Reducing Toxicity After Subarachnoid Hemorrhage]).
Hänggi D, Etminan N, Aldrich F, Steiger HJ, et al · · 2017 · cited 42× · PMID 27932607 · DOI 10.1161/strokeaha.116.014250
A Site-Specific, Sustained-Release Drug Delivery System for Aneurysmal Subarachnoid Hemorrhage.
Hänggi D, Etminan N, Steiger HJ, Johnson M, et al · · 2016 · cited 16× · PMID 26935204 · DOI 10.1007/s13311-016-0424-8
Nimodipine pharmacokinetics after intraventricular injection of sustained-release nimodipine for subarachnoid hemorrhage.
Macdonald RL, Hänggi D, Strange P, Steiger HJ, et al · · 2021 · cited 6× · PMID 31812149 · DOI 10.3171/2019.9.jns191366
Neurocritical Care Society 14(th) Annual Meeting.
· 2016 · cited 1× · PMID 27516104 · DOI 10.1007/s12028-016-0301-7

Verify or expand the search:

Other trials of Nimodipine

Trials testing the same drug.

NCT06900998 — Pilot Study: Effects of Nimodipine on Alcohol Drinking · Phase 2 · not yet recruiting
NCT07048522 — Perioperative Intravenous Nimodipine Trial · NA · recruiting
NCT04649398 — Cerebral Nimodipine Concentrations Following Oral, Intra-venous and Intra-arterial Administration · unknown
NCT03925025 — Effectiveness of Calcium Channel Blockade for OP and Carbamate Pesticide Poisoning · Phase 3 · completed
NCT04100824 — Stellate Ganglion Block as Adjuvant Therapy to ca Channel Blocker · Phase 2 · completed

Other recruiting trials for Ruptured Cerebral Aneurysm

Currently open trials in the same condition.

NCT05550571 — A Medical Device to Treat Wide-Neck Brain Aneurysms · NA · active not recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01893190 (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: 31 January 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/NCT01893190.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing