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NCT02893826

Multicenter, Controlled, Randomized, Safety and Pharmacokinetic Study Comparing Intracisternal EG-1962 to Standard of Care Enteral Nimodipine in Adults With Aneurysmal Subarachnoid Hemorrhage

Terminated Phase 1 Last updated 24 July 2018
What this trial tests

Phase 1 trial testing EG-1962 (nimodipine microparticles) in Subarachnoid Hemorrhage, Aneurysmal in 6 participants. Terminated before completion.

Timeline
1 September 2016
Primary endpoint
1 December 2017
1 March 2018

Quick facts

Lead sponsorEdge Therapeutics Inc
PhasePhase 1
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment6
Start date1 September 2016
Primary completion1 December 2017
Estimated completion1 March 2018
Sites4 locations across United States, Canada

Drugs / interventions tested

Conditions studied

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.

Sponsor's own description

Safety and Pharmacokinetic study comparing intracisternal EG-1962 to enternal nimopidine in the treatment of aneurysmal subarachnoid hemorrhage.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Assessment of Safety and Biodistribution of AAVrh.10hCLN2 Following Intracisternal Administration in Nonhuman Primates for the Treatment of CLN2 Batten Disease.
    De BP, Rosenberg JB, Selvan N, Wilson I, et al · · 2023 · cited 8× · PMID 37624739 · DOI 10.1089/hum.2023.067

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