Subarachnoid HemorrhageDOPASTNCT01137110
Short Duration Levetiracetam to Extended Course for Seizure Prophylaxis After aSAH
A study testing Brief LEV and Extended LEV in people with Subarachnoid Hemorrhage, run by Washington University School of Medicine at 1 site in United States.
Trial summary
Our primary objective is to compare two treatment options for prevention of seizures following a subarachnoid hemorrhage and determine if a short-course regimen of levetiracetam is as efficacious in the prevention of in-hospital seizures when compared to an extended course. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Subarachnoid Hemorrhage
- What is being tested?
- Brief LEV and Extended LEV
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2010to 1 Jan 2017
- Phase
- Interventional
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years of age
- Diagnosis of spontaneous SAH
Who cannot join
- SAH secondary to trauma or arteriovenous malformation
- Early death (defined as death within 3 days of presentation)
- Known allergy to levetiracetam
- Know seizure history on chronic AEDs
- Pregnancy
- Current incarceration
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Short Duration Levetiracetam to Extended Course Levetiracetam for Seizure Prophylaxis Following Subarachnoid Hemorrhage
Our primary objective is to compare two treatment options for prevention of seizures following a subarachnoid hemorrhage and determine if a short-course regimen of levetiracetam is as efficacious in the prevention of in-hospital seizures when compared to an extended course.
Read the detailed description
This is a prospective, single-center, randomized, controlled trial. Patients admitted with spontaneous SAH (and meet enrollment criteria) will be randomized to either levetiracetam 1000 mg twice daily for 3 days or levetiracetam 1000mg twice daily until hospital discharge.
- Conditions
- Subarachnoid Hemorrhage
- Being tested
- Brief LEV, Extended LEV
- Keywords
- Subarachnoid Hemorrhage, Seizure Prophylaxis, Levetiracetam
- Medical subject headings
- Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief LEVOther
Levetiracetam 1000mg BID x 3 days for prophylaxis
Extended LEVOther
Levetiracetam 1000mg BID for length of hospital stay for prophylaxis
| Study group | Role | What they receive |
|---|---|---|
| Brief LEV | Other | Administration of three days of levetiracetam twice daily after SAH Receives: Other: Brief LEV |
| Extended LEV | Other | Administration of levetiracetam twice daily after SAH Receives: Other: Extended LEV |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-hospital Seizures
from admission to In-hospital seizures after aSAH
Measured: from hospital admission to hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2010 (estimated)
- Study start1 May 2010
- Primary completion1 Jan 2013
- Study completion1 Jan 2017
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 Subarachnoid HemorrhageStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Theresa Human-Murphy, Washington University School of Medicine
- Investigators
- Theresa Human-Murphy, Principal investigator, Barnes-Jewish Hospital, Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01137110
- Sponsor's protocol ID
- 09-1717
- Acronym
- DOPAST
- Status last verified
- Apr 2019
- First submitted
- 28 May 2010
- Last updated
- 12 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Short Duration Levetiracetam to Extended Course Levetiracetam for Seizure Prophylaxis Following Subarachnoid Hemorrhage
- ClinicalTrials.gov ID
- NCT01137110
- Acronym / sponsor ID
- DOPAST / 09-1717
- Conditions
- Subarachnoid Hemorrhage
- Keywords
- Subarachnoid Hemorrhage, Seizure Prophylaxis, Levetiracetam
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 1 May 2010 (actual)
- Primary completion
- 1 Jan 2013 (actual)
- Study completion
- 1 Jan 2017 (actual)
- First posted
- 4 Jun 2010 (estimated)
- Results
- Posted 12 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Our primary objective is to compare two treatment options for prevention of seizures following a subarachnoid hemorrhage and determine if a short-course regimen of levetiracetam is as efficacious in the prevention of in-hospital seizures when compared to an extended course.
Detailed description
This is a prospective, single-center, randomized, controlled trial. Patients admitted with spontaneous SAH (and meet enrollment criteria) will be randomized to either levetiracetam 1000 mg twice daily for 3 days or levetiracetam 1000mg twice daily until hospital discharge.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brief LEV | Other | Other: Brief LEVAdministration of three days of levetiracetam twice daily after SAH |
| Extended LEV | Other | Other: Extended LEVAdministration of levetiracetam twice daily after SAH |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age >18 years of age
- Diagnosis of spontaneous SAH
Key exclusion criteria (6 listed)
- SAH secondary to trauma or arteriovenous malformation
- Early death (defined as death within 3 days of presentation)
- Known allergy to levetiracetam
- Know seizure history on chronic AEDs
- Pregnancy
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 |
|---|---|---|
| Brief LEVLevetiracetam 1000mg BID x 3 days for prophylaxis | Other | Brief LEV |
| Extended LEVLevetiracetam 1000mg BID for length of hospital stay for prophylaxis | Other | Extended LEV |
Primary outcome
In-hospital Seizures
Time frame: from hospital admission to hospital discharge
from admission to In-hospital seizures after aSAH
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Subarachnoid Hemorrhage
Not yet recruitingPhase 3
TicAgreLor Versus Placebo to Prevent Cerebral ISCHemia in anEuRysmal Low Grade SAH A Double Blinded Randomised Controlled Study
Subarachnoid Hemorrhage, Aneurysmal, Brain Ischemia
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
RecruitingObservational study
Determining the Clinical Impact and Prevalence of Hemorrhagic Subtypes in Perimesencephalic Subarachnoid Hemorrhage
Subarachnoid Hemorrhage, Spontaneous, Subarachnoid Hemorrhage, Aneurysmal
RecruitingObservational study
Smartphone Enabled Detection of Cognitive Motor Dissociation in the ICU
Traumatic Brain Injury (TBI) Patients, Intracerebral Hemorrhage
Not yet recruitingObservational study
Integrating Wearable Monitoring and Clinical Data for Stroke Early Warning
Stroke, Ischemic Stroke
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.
Theresa Human-Murphy principal investigator
Barnes-Jewish Hospital, Washington University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief LEV and Extended LEV in people with Subarachnoid Hemorrhage, run by Washington University School of Medicine 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 2 inclusion and 6 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: finished, as of the sponsor's last update on 12 Jul 2019. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jul 2019). 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?
In-hospital Seizures (time frame: from hospital admission to hospital discharge). 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 12 Jul 2019.