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Based on DMC recommendation to discontinue EG-01-1962-03
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Safety and Pharmacokinetic study comparing intracisternal EG-1962 to enternal nimopidine in the treatment of aneurysmal subarachnoid hemorrhage.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EG-1962 Group | Experimental | 1 dose of intracisternal EG-1962 (nimodipine microparticles) 600 mg |
|
| Enteral Nimodipine Group | Active Comparator | Up to a total of 21 days of enteral nimodipine (including nimodipine received prior to randomization) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EG-1962 (nimodipine microparticles) | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events | 90 Days | |
| Proportion of subjects with delayed cerebral infarctions present on CT at Day 30 | 30 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic (PK) profile of EG-1962 as measured by maximum drug concentration in plasma (Cmax) | At the time of the first post-operation blood draw and every 6 hours (± 30 minutes) for the first 24 hours and daily thereafter until hospital discharge or Day 21, whichever occurs first and Day 30 | |
| Pharmacokinetic (PK) profile of EG-1962 as measured by time to reach maximum drug concentration in plasma (Tmax) |
| Measure | Description | Time Frame |
|---|---|---|
| Extended Glasgow Outcome Scale (GOSE) | Proportion of subjects with a favorable outcome measured on the Extended Glasgow Outcome Scale (GOSE) at Day 90 | Day 90 |
| Montreal Cognitive Assessment (MoCA) | Proportion of subjects with a favorable outcome measured on the Montreal Cognitive Assessment (MoCA) at Day 90 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| R. Loch Macdonald, MD, PhD | Edge Therapeutics Inc | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dignity Health; St. Joseph's Hospital and Medical Center | Phoenix | Arizona | 85013 | United States | ||
| University of California San Francisco |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37624739 | Derived | 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. | |
| 32985652 |
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| Enteral Nimodipine |
| Drug |
|
|
| At the time of the first post-operation blood draw and every 6 hours (± 30 minutes) for the first 24 hours and daily thereafter until hospital discharge or Day 21, whichever occurs first and Day 30 |
| Pharmacokinetic (PK) profile of EG-1962 as measured by steady state concentration (Css) | At the time of the first post-operation blood draw and every 6 hours (± 30 minutes) for the first 24 hours and daily thereafter until hospital discharge or Day 21, whichever occurs first and Day 30 |
| Pharmacokinetic (PK) profile of EG-1962 as measured by AUC area under the plasma concentration-time curve (AUC) from 0 to 24 hours (AUC024h) | At the time of the first post-operation blood draw and every 6 hours (± 30 minutes) for the first 24 hours |
| Pharmacokinetic (PK) profile of EG-1962 as measured by AUC from 0 to Day 10 (AUC0-10) | At the time of the first post-operation blood draw and every 6 hours (± 30 minutes) for the first 24 hours and up to Day 10 |
| Pharmacokinetic (PK) profile of EG-1962 as measured by AUC from 0 to Day 14 (AUC0-14) | At the time of the first post-operation blood draw and every 6 hours (± 30 minutes) for the first 24 hours and up to Day 14 |
| Pharmacokinetic (PK) profile of EG-1962 as measured by AUC from 0 to last plasma concentration (AUC0-last) | At the time of the first post-operation blood draw and every 6 hours (± 30 minutes) for the first 24 hours and up to last plasma concentration |
| Day 90 |
| San Francisco |
| California |
| 94143 |
| United States |
| University of Maryland Medical Systems | Baltimore | Maryland | 21201 | United States |
| University of Alberta Hospital/Mackenzie Health Sciences Centre | Edmonton | Alberta | T6G 2B7 | Canada |
| Derived |
| 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. |
| ID | Term |
|---|---|
| D013345 | Subarachnoid Hemorrhage |
| D000783 | Aneurysm |
| D012421 | Rupture |
| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| C000716088 | EG-1962 |
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