Subarachnoid Hemorrhage, AneurysmalPhase 1NCT02893826
Safety/Pharmacokinetic Study Comparing Intracisternal EG-1962 to Standard of Care Enteral Nimodipine in Adults With aSAH
A Phase 1 study testing EG-1962 (nimodipine microparticles) and Enteral Nimodipine in people with Subarachnoid Hemorrhage, Aneurysmal, run by Edge Therapeutics Inc at 4 sites in 2 countries.
Trial summary
Safety and Pharmacokinetic study comparing intracisternal EG-1962 to enternal nimopidine in the treatment of aneurysmal subarachnoid hemorrhage. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Subarachnoid Hemorrhage, Aneurysmal
- What is being tested?
- EG-1962 (nimodipine microparticles) and Enteral Nimodipine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Sep 2016to Mar 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ruptured saccular aneurysm repaired by neurosurgical clipping
- Subarachnoid hemorrhage on computed tomography (CT) scan of grade 2-4 on the modified Fischer scale
- WFNS grade 1 or 2 assessed during the Pre-randomization Phase. If WFNS grade 2, must not require an EVD prior to aneurysm repair
Who cannot join
- Major complication during aneurysm repair such as, but not limited to, massive intraoperative hemorrhage, brain swelling, arterial occlusion or inability to secure the ruptured aneurysm
- Angiographic vasospasm prior to randomization
- Evidence of cerebral infarction with neurological deficit
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
University of Maryland Medical Systems
Baltimore, Maryland, 21201
Dignity Health; St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013
University of California San Francisco
San Francisco, California, 94143
Canada1 site
University of Alberta Hospital/Mackenzie Health Sciences Centre
Edmonton, Alberta, T6G 2B7
About this study
Official title: Multicenter, Controlled, Randomized, Safety and Pharmacokinetic Study Comparing Intracisternal EG-1962 to Standard of Care Enteral Nimodipine in Adults With Aneurysmal Subarachnoid Hemorrhage
Safety and Pharmacokinetic study comparing intracisternal EG-1962 to enternal nimopidine in the treatment of aneurysmal subarachnoid hemorrhage.
- Conditions
- Subarachnoid Hemorrhage, Aneurysmal
- Being tested
- EG-1962 (nimodipine microparticles), Enteral Nimodipine
- Keywords
- Aneurysm, Ruptured, nimodipine, subarachnoid hemorrhage
- Medical subject headings
- Subarachnoid Hemorrhage, Aneurysm, Rupture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EG-1962 (nimodipine microparticles)Drug
Also called Single intracisternal adminstration
Enteral NimodipineDrug
Also called Administered for up to 21 days
| Study group | Role | What they receive |
|---|---|---|
| EG-1962 Group | Experimental | 1 dose of intracisternal EG-1962 (nimodipine microparticles) 600 mg Receives: Drug: EG-1962 (nimodipine microparticles) |
| Enteral Nimodipine Group | Active comparator | Up to a total of 21 days of enteral nimodipine (including nimodipine received prior to randomization) Receives: Drug: Enteral Nimodipine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events
Measured: 90 Days
Proportion of subjects with delayed cerebral infarctions present on CT at Day 30
Measured: 30 Days
Secondary outcomes (7)
Pharmacokinetic (PK) profile of EG-1962 as measured by maximum drug concentration in plasma (Cmax)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionDec 2017
- Study completionMar 2018
Why it stopped: Based on DMC recommendation to discontinue EG-01-1962-03
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Subarachnoid Hemorrhage, AneurysmalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edge Therapeutics Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- R. Loch Macdonald, MD, PhD, Study chair, Edge Therapeutics Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02893826
- Sponsor's protocol ID
- EG-01-1962-04
- Status last verified
- Jul 2018
- First submitted
- 25 Aug 2016
- Last updated
- 26 Jul 2018
- Results posted
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 37624739Macdonald 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.
PubMed 32985652
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Controlled, Randomized, Safety and Pharmacokinetic Study Comparing Intracisternal EG-1962 to Standard of Care Enteral Nimodipine in Adults With Aneurysmal Subarachnoid Hemorrhage
- ClinicalTrials.gov ID
- NCT02893826
- Acronym / sponsor ID
- EG-01-1962-04
- Conditions
- Subarachnoid Hemorrhage, Aneurysmal
- Keywords
- Aneurysm, Ruptured, nimodipine, subarachnoid hemorrhage
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Based on DMC recommendation to discontinue EG-01-1962-03
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Edge Therapeutics IncIndustry (pharma, biotech, devices)
- Study start
- Sep 2016
- Primary completion
- Dec 2017 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 9 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Safety and Pharmacokinetic study comparing intracisternal EG-1962 to enternal nimopidine in the treatment of aneurysmal subarachnoid hemorrhage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EG-1962 Group | Experimental | Drug: EG-1962 (nimodipine microparticles)1 dose of intracisternal EG-1962 (nimodipine microparticles) 600 mg |
| Enteral Nimodipine Group | Active comparator | Drug: Enteral NimodipineUp to a total of 21 days of enteral nimodipine (including nimodipine received prior to randomization) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ruptured saccular aneurysm repaired by neurosurgical clipping
- Subarachnoid hemorrhage on computed tomography (CT) scan of grade 2-4 on the modified Fischer scale
- WFNS grade 1 or 2 assessed during the Pre-randomization Phase. If WFNS grade 2, must not require an EVD prior to aneurysm repair
Key exclusion criteria (3 listed)
- Major complication during aneurysm repair such as, but not limited to, massive intraoperative hemorrhage, brain swelling, arterial occlusion or inability to secure the ruptured aneurysm
- Angiographic vasospasm prior to randomization
- Evidence of cerebral infarction with neurological deficit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EG-1962 (nimodipine microparticles)Also: Single intracisternal adminstration | Drug | EG-1962 Group |
| Enteral NimodipineAlso: Administered for up to 21 days | Drug | Enteral Nimodipine Group |
Primary outcome
Incidence and severity of adverse events
Time frame: 90 Days
Proportion of subjects with delayed cerebral infarctions present on CT at Day 30
Time frame: 30 Days
7 secondary outcomes
Pharmacokinetic (PK) profile of EG-1962 as measured by maximum drug concentration in plasma (Cmax)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Results and safety
The study was stopped early (reason given: Based on DMC recommendation to discontinue EG-01-1962-03). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2018.
- Derived from this study: PubMed 37624739De 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.
- Derived from this study: PubMed 32985652Macdonald 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
R. Loch Macdonald, MD, PhD study chair
Edge Therapeutics Inc
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EG-1962 (nimodipine microparticles) and Enteral Nimodipine in people with Subarachnoid Hemorrhage, Aneurysmal, run by Edge Therapeutics Inc at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Based on DMC recommendation to discontinue EG-01-1962-03). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adverse events (time frame: 90 Days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02893826, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2018.