Safety/Pharmacokinetic Study Comparing Intracisternal EG-1962 to Standard of Care Enteral Nimodipine in Adults With aSAH
NCT ID: NCT02893826
Last Updated: 2018-07-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
6 participants
INTERVENTIONAL
2016-09-30
2018-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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EG-1962 Group
1 dose of intracisternal EG-1962 (nimodipine microparticles) 600 mg
EG-1962 (nimodipine microparticles)
Enteral Nimodipine Group
Up to a total of 21 days of enteral nimodipine (including nimodipine received prior to randomization)
Enteral Nimodipine
Interventions
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EG-1962 (nimodipine microparticles)
Enteral Nimodipine
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Subarachnoid hemorrhage on computed tomography (CT) scan of grade 2-4 on the modified Fischer scale
3. WFNS grade 1 or 2 assessed during the Pre-randomization Phase. If WFNS grade 2, must not require an EVD prior to aneurysm repair
Exclusion Criteria
2. Angiographic vasospasm prior to randomization
3. Evidence of cerebral infarction with neurological deficit
18 Years
75 Years
ALL
No
Sponsors
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Edge Therapeutics Inc
INDUSTRY
Responsible Party
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Principal Investigators
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R. Loch Macdonald, MD, PhD
Role: STUDY_CHAIR
Edge Therapeutics Inc
Locations
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Dignity Health; St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States
University of California San Francisco
San Francisco, California, United States
University of Maryland Medical Systems
Baltimore, Maryland, United States
University of Alberta Hospital/Mackenzie Health Sciences Centre
Edmonton, Alberta, Canada
Countries
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References
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De BP, Rosenberg JB, Selvan N, Wilson I, Yusufzai N, Greco A, Kaminsky SM, Heier LA, Ricart Arbona RJ, Miranda IC, Monette S, Nair A, Khanna R, Crystal RG, Sondhi D. Assessment of Safety and Biodistribution of AAVrh.10hCLN2 Following Intracisternal Administration in Nonhuman Primates for the Treatment of CLN2 Batten Disease. Hum Gene Ther. 2023 Sep;34(17-18):905-916. doi: 10.1089/hum.2023.067.
Macdonald RL, Hanggi D, Ko NU, Darsaut TE, Carlson AP, Wong GK, Etminan N, Mayer SA, Aldrich EF, Diringer MN, Ng D, Strange P, Bleck T, Grubb R, Suarez JI. NEWTON-2 Cisternal (Nimodipine Microparticles to Enhance Recovery While Reducing Toxicity After Subarachnoid Hemorrhage): A Phase 2, Multicenter, Randomized, Open-Label Safety Study of Intracisternal EG-1962 in Aneurysmal Subarachnoid Hemorrhage. Neurosurgery. 2020 Dec 15;88(1):E13-E26. doi: 10.1093/neuros/nyaa430.
Other Identifiers
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EG-01-1962-04
Identifier Type: -
Identifier Source: org_study_id
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