Cerebral VasospasmPhase 2NCT01810302
Safety Study of Nicardipine to Treat Cerebral Vasospasm
A Phase 2 study testing Nicardipine hydrochloride and Preservative-free normal saline in people with Cerebral Vasospasm, run by University of Florida at 1 site in United States.
Trial summary
The purpose of this study is to determine if intrathecal nicardipine is safe for the treatment of cerebral vasospasm. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Vasospasm
- What is being tested?
- Nicardipine hydrochloride and Preservative-free normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Jan 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female 18 years of age and older
- Subarachnoid hemorrhage documented on head CT
- Fisher Grade 3 or 4
- Hunt Hess Grade 1-5
- Cerebral aneurysm as definitive source of subarachnoid hemorrhage
- Cerebral aneurysm must be treated via open or endovascular techniques
- Presence of external ventricular drain
- Written informed consent obtained from subject or subject's legally authorized representative
Who cannot join
- Absence or inability to have an external ventricular drain (coagulopathy)
- Non-aneurysmal subarachnoid hemorrhage (perimesencephalic)
- Untreated cerebral aneurysm
- Inability to be randomized prior to post-hemorrhage day 4
- Elevated intra-cranial pressures that would preclude external ventricular drain clamping for 30-60 minutes
- Inability to administer study medication (severe intra-ventricular hemorrhage, occluded external ventricular drain)
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- Inability to obtain angiography (coagulopathy, renal failure)
- Pregnant
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intraventricular Nicardipine for the Treatment of Cerebral Vasospasm: Prospective Pilot Study
The purpose of this study is to determine if intrathecal nicardipine is safe for the treatment of cerebral vasospasm.
Read the detailed description
Subarachnoid hemorrhage accounts for approximately 5% of all strokes and affects 30,000 Americans per year. Poor outcome from aneurysmal subarachnoid hemorrhage (SAH) occurs in 50 to 75% of patients, and this is attributed to secondary ischemia in approximately 30% of patients. This delayed cerebral ischemia has been attributed to the anatomic narrowing of arteries in the cerebral vasculature which occurs following SAH.
Because of this relationship between cerebral vasospasm, cerebral ischemia, and poor outcome, there has been significant effort to establish treatments that decrease the incidence of vasospasm after SAH. Currently, medications and hemodynamic maneuvers are used as standard of care for the treatment of vasospasm and to improve outcome after SAH.
The calcium channel blocker, nimodipine, is one of the few treatments for vasospasm that has been shown to be of proven benefit. Nicardipine is another calcium channel blocker that has been evaluated in several studies via an intravenous administration route. These studies did show significant improvements in symptomatic and angiographic vasospasm, although a benefit in outcome was not seen. However, the intravenous administration of nicardipine was associated with significant systemic side effects that may have affected outcome including hypotension, pulmonary edema, and azotemia.
The administration of nicardipine via an intrathecal route avoids the systemic complications associated with intravenous dosing since the direct cerebrospinal fluid dosing is much lower. The result is that the systemic concentration will remain low avoiding systemic side effects, and central nervous system concentration will remain high. We propose that this difference may improve outcomes while minimizing complication related effects on patient outcomes.
- Conditions
- Cerebral Vasospasm
- Being tested
- Nicardipine hydrochloride, Preservative-free normal saline
- Keywords
- Vasospasm, Subarachnoid hemorrhage, Aneurysmal subarachnoid hemorrhage, Nicardipine, Intrathecal, SAH, aSAH
- Medical subject headings
- Vasospasm, Intracranial, Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicardipine hydrochlorideDrug
Also called Nicardipine, Cardene
Nicardipine hydrochloride 4mg by intrathecal administration twice a day until post-hemorrhage day 10.
Preservative-free normal salineDrug
Also called Normal saline, Placebo, NS
Preservative-free normal saline 1.6 mL by intrathecal administration twice a day until post-hemorrhage day 10.
| Study group | Role | What they receive |
|---|---|---|
| Nicardipine hydrochloride | Experimental | Nicardipine hydrochloride 4mg by intrathecal administration twice a day until post-hemorrhage day 10. Receives: Drug: Nicardipine hydrochloride |
| Preservative-free normal saline | Placebo comparator | Preservative-free normal saline 1.6 mL by intrathecal administration twice a day until post-hemorrhage day 10. Receives: Drug: Preservative-free normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Bacterial Meningitis.
Measured: Day 1 of study drug until post-hemorrhage day 10.
Secondary outcomes (1)
Number of Participants With Cerebral Vasospasm.
Measured: Day 1 of study drug until post-hemorrhage day 10.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2013 (estimated)
- Study startAug 2013
- Primary completionJan 2014
- Study completionJan 2014
Why it stopped: Unable to secure drug.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cerebral VasospasmStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Spiros L. Blackburn, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01810302
- Sponsor's protocol ID
- 034-2013
- Status last verified
- Aug 2014
- First submitted
- 11 Mar 2013
- Last updated
- 29 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraventricular Nicardipine for the Treatment of Cerebral Vasospasm: Prospective Pilot Study
- ClinicalTrials.gov ID
- NCT01810302
- Acronym / sponsor ID
- 034-2013
- Conditions
- Cerebral Vasospasm
- Keywords
- Vasospasm, Subarachnoid hemorrhage, Aneurysmal subarachnoid hemorrhage, Nicardipine, Intrathecal, SAH, aSAH
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to secure drug.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 13 Mar 2013 (estimated)
- Results
- Posted 29 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if intrathecal nicardipine is safe for the treatment of cerebral vasospasm.
Detailed description
Subarachnoid hemorrhage accounts for approximately 5% of all strokes and affects 30,000 Americans per year. Poor outcome from aneurysmal subarachnoid hemorrhage (SAH) occurs in 50 to 75% of patients, and this is attributed to secondary ischemia in approximately 30% of patients. This delayed cerebral ischemia has been attributed to the anatomic narrowing of arteries in the cerebral vasculature which occurs following SAH.
Because of this relationship between cerebral vasospasm, cerebral ischemia, and poor outcome, there has been significant effort to establish treatments that decrease the incidence of vasospasm after SAH. Currently, medications and hemodynamic maneuvers are used as standard of care for the treatment of vasospasm and to improve outcome after SAH.
The calcium channel blocker, nimodipine, is one of the few treatments for vasospasm that has been shown to be of proven benefit. Nicardipine is another calcium channel blocker that has been evaluated in several studies via an intravenous administration route. These studies did show significant improvements in symptomatic and angiographic vasospasm, although a benefit in outcome was not seen. However, the intravenous administration of nicardipine was associated with significant systemic side effects that may have affected outcome including hypotension, pulmonary edema, and azotemia.
The administration of nicardipine via an intrathecal route avoids the systemic complications associated with intravenous dosing since the direct cerebrospinal fluid dosing is much lower. The result is that the systemic concentration will remain low avoiding systemic side effects, and central nervous system concentration will remain high. We propose that this difference may improve outcomes while minimizing complication related effects on patient outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nicardipine hydrochloride | Experimental | Drug: Nicardipine hydrochlorideNicardipine hydrochloride 4mg by intrathecal administration twice a day until post-hemorrhage day 10. |
| Preservative-free normal saline | Placebo comparator | Drug: Preservative-free normal salinePreservative-free normal saline 1.6 mL by intrathecal administration twice a day until post-hemorrhage day 10. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female 18 years of age and older
- Subarachnoid hemorrhage documented on head CT
- Fisher Grade 3 or 4
- Hunt Hess Grade 1-5
- Cerebral aneurysm as definitive source of subarachnoid hemorrhage
Key exclusion criteria (9 listed)
- Absence or inability to have an external ventricular drain (coagulopathy)
- Non-aneurysmal subarachnoid hemorrhage (perimesencephalic)
- Untreated cerebral aneurysm
- Inability to be randomized prior to post-hemorrhage day 4
- Elevated intra-cranial pressures that would preclude external ventricular drain clamping for 30-60 minutes
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 |
|---|---|---|
| Nicardipine hydrochlorideAlso: Nicardipine, CardeneNicardipine hydrochloride 4mg by intrathecal administration twice a day until post-hemorrhage day 10. | Drug | Nicardipine hydrochloride |
| Preservative-free normal salineAlso: Normal saline, Placebo, NSPreservative-free normal saline 1.6 mL by intrathecal administration twice a day until post-hemorrhage day 10. | Drug | Preservative-free normal saline |
Primary outcome
Number of Participants With Bacterial Meningitis.
Time frame: Day 1 of study drug until post-hemorrhage day 10.
1 secondary outcome
Number of Participants With Cerebral Vasospasm.
Time frame: Day 1 of study drug until post-hemorrhage day 10.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Cerebral Vasospasm
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Endovascular Therapy for Cerebral Vasospasm After Aneurysmal Subarachnoid Hemorrhage
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Noninvasive CA Monitoring Validation and Autonomic Modulation in Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Hemorrhage, Aneurysmal, Delayed Cerebral Ischemia
Not yet recruitingPhase 4
Lumbar Drain With Intrathecal Nicardipine in Aneurysmal Subarachnoid Hemorrhage
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The Effect of Transcutaneous Vagal Nerve Stimulation (tVNS) on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid Hemorrhage
Aneurysmal Subarachnoid Hemorrhage, Vasospasm, Cerebral
RecruitingObservational study
Nitric Oxide Consumption as a Predictor of Vasospasm in Subarachnoid Hemorrhage
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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.
Spiros L. Blackburn, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nicardipine hydrochloride and Preservative-free normal saline in people with Cerebral Vasospasm, run by University of Florida at 1 site in United States.
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 8 inclusion and 9 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 29 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Bacterial Meningitis. (time frame: Day 1 of study drug until post-hemorrhage day 10.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Aug 2014.