Status EpilepticusPhase 3NCT00265616
Treatment of Refractory Status Epilepticus
A Phase 3 study testing propofol and thiopental/pentobarbital in people with Status Epilepticus, run by Brigham and Women's Hospital at 5 sites in 2 countries.
Trial summary
The purpose of this study is to determine whether propofol or barbiturates should be preferred in the treatment of status epilepticus (continuous seizure activity) refractory to 2 standard antiepileptic agents. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Status Epilepticus
- What is being tested?
- propofol and thiopental/pentobarbital
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 5 sitesin 2 countries
- Study dates
- May 2006to Mar 2010
- Phase
- Phase 3
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with refractory status epilepticus not due to cerebral anoxia, needing coma induction for clinical management.
Who cannot join
- Age < 16 years old.
- Known pregnancy.
- Cerebral anoxia as SE etiology.
- Epilepsia partialis continua (simple partial SE).
- Known intolerance to the study drugs.
- Known mitochondrial disorder, hyperlipidemia, or significant rhabdomyolysis.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Switzerland3 sites
Inselspital
Bern, Canton of Bern
Hôpitaux Universitaires de Genève
Geneva
CHUV
Lausanne, Canton of Vaud
United States2 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: A Randomized Clinical Trial for the Treatment of Refractory Status Epilepticus
The purpose of this study is to determine whether propofol or barbiturates should be preferred in the treatment of status epilepticus (continuous seizure activity) refractory to 2 standard antiepileptic agents.
Read the detailed description
Refractory status epilepticus (SE) develops in 31%-44% of patients with SE, with a mortality of 16%-23%. Coma induction is advocated for its management. Propofol and barbiturates are the most used agents, but no comparative study has been performed. In consideration of the uncertainty regarding the relative effectiveness, despite several retrospective data, a prospective investigation is needed.
The objective is to assess the effectiveness (SE control, adverse events) of a first course of propofol versus barbiturates in the treatment of refractory SE, in adults with refractory SE not due to cerebral anoxia.
Comparison: Coma induction with standardized doses of propofol or barbiturates titrated towards burst-suppression on EEG, then assessment of the proportion of patients achieving a control of SE.
- Conditions
- Status Epilepticus
- Being tested
- propofol, thiopental/pentobarbital
- Keywords
- Refractory status epilepticus,, coma-induction,, treatment,, propofol,, barbiturates,, efficacy,, safety.
- Medical subject headings
- Status Epilepticus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
propofolDrug
Also called Disoprivan
liquid, mg/kg.h, titrated after EEG
thiopental/pentobarbitalDrug
Also called Pentotal /Thiopentone
liquid, mg/kg.h, titrated after EEG
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | propofol, 2mg/kg as bolus, then titrated up to EEG burst-suppression as a continuous infusion; no maximum doses defined Receives: Drug: propofol |
| 2 | Active comparator | thiopental/pentobarbital, 2mg/kg as bolus, then titrated up to EEG burst-suppression as a continuous infusion; no maximum doses defined Receives: Drug: thiopental/pentobarbital |
What is being measured
The primary outcome is the main question the study is designed to answer.
Refractory Status Epilepticus Controlled With First Course of Study Drug
Control of status epilepticus refractory to benzodiazepines and a first antiepileptic drug after administration of the study drug; dichotomous assessment (yes/no)
Measured: after return of continuous EEG activity (typically after 36 hours - 5 days)
Secondary outcomes (5)
Clinical Outcome at Day 21
Return to baseline clinical conditions (i.e.: no new handicap, no death)
Measured: 21 days
Patients With Infectious Complications Requiring Specific Treatment
Measured: 10 days
Patients With Hypotension Requiring Specific Treatment
Measured: 10 days
Patients With Propofol Infusion Syndrome
Propofol infusion syndrome (PRIS) is a severe metabolic alteration with elevation of lactate, CK, and triglycerides.
Measured: 10 days
Intubation Time in Survivors
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2005 (estimated)
- Study startMay 2006
- Primary completionMar 2010
- Study completionMar 2010
Why it stopped: Insufficient recruitment
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Status EpilepticusStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea O. Rossetti, MD, Brigham and Women's Hospital
- Investigators
- Andrea O. Rossetti, MD, Principal investigator, BrighamHospital/CHUV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00265616
- Sponsor's protocol ID
- RSE study, protocol#62/06
- Status last verified
- Apr 2013
- First submitted
- 13 Dec 2005
- Last updated
- 9 Apr 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Rossetti AO, Milligan TA, Vulliemoz S, Michaelides C, Bertschi M, Lee JW. A randomized trial for the treatment of refractory status epilepticus. Neurocrit Care. 2011 Feb;14(1):4-10. doi: 10.1007/s12028-010-9445-z.
PubMed 20878265
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial for the Treatment of Refractory Status Epilepticus
- ClinicalTrials.gov ID
- NCT00265616
- Acronym / sponsor ID
- RSE study, protocol#62/06
- Conditions
- Status Epilepticus
- Keywords
- Refractory status epilepticus,, coma-induction,, treatment,, propofol,, barbiturates,, efficacy,, safety.
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient recruitment
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- May 2006
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 15 Dec 2005 (estimated)
- Results
- Posted 4 Apr 2013
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 whether propofol or barbiturates should be preferred in the treatment of status epilepticus (continuous seizure activity) refractory to 2 standard antiepileptic agents.
Detailed description
Refractory status epilepticus (SE) develops in 31%-44% of patients with SE, with a mortality of 16%-23%. Coma induction is advocated for its management. Propofol and barbiturates are the most used agents, but no comparative study has been performed. In consideration of the uncertainty regarding the relative effectiveness, despite several retrospective data, a prospective investigation is needed.
The objective is to assess the effectiveness (SE control, adverse events) of a first course of propofol versus barbiturates in the treatment of refractory SE, in adults with refractory SE not due to cerebral anoxia.
Comparison: Coma induction with standardized doses of propofol or barbiturates titrated towards burst-suppression on EEG, then assessment of the proportion of patients achieving a control of SE.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: propofolpropofol, 2mg/kg as bolus, then titrated up to EEG burst-suppression as a continuous infusion; no maximum doses defined |
| 2 | Active comparator | Drug: thiopental/pentobarbitalthiopental/pentobarbital, 2mg/kg as bolus, then titrated up to EEG burst-suppression as a continuous infusion; no maximum doses defined |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with refractory status epilepticus not due to cerebral anoxia, needing coma induction for clinical management.
Key exclusion criteria (6 listed)
- Age < 16 years old.
- Known pregnancy.
- Cerebral anoxia as SE etiology.
- Epilepsia partialis continua (simple partial SE).
- Known intolerance to the study drugs.
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 |
|---|---|---|
| propofolAlso: Disoprivanliquid, mg/kg.h, titrated after EEG | Drug | 1 |
| thiopental/pentobarbitalAlso: Pentotal /Thiopentoneliquid, mg/kg.h, titrated after EEG | Drug | 2 |
Primary outcome
Refractory Status Epilepticus Controlled With First Course of Study Drug
Time frame: after return of continuous EEG activity (typically after 36 hours - 5 days)
Control of status epilepticus refractory to benzodiazepines and a first antiepileptic drug after administration of the study drug; dichotomous assessment (yes/no)
5 secondary outcomes
Clinical Outcome at Day 21
Time frame: 21 days
Patients With Infectious Complications Requiring Specific Treatment
Time frame: 10 days
Patients With Hypotension Requiring Specific Treatment
Time frame: 10 days
Patients With Propofol Infusion Syndrome
Time frame: 10 days
Intubation Time in Survivors
Time frame: Up to 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20878265Rossetti AO, Milligan TA, Vulliemoz S, Michaelides C, Bertschi M, Lee JW. A randomized trial for the treatment of refractory status epilepticus. Neurocrit Care. 2011 Feb;14(1):4-10. doi: 10.1007/s12028-010-9445-z.
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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.
Andrea O. Rossetti, MD principal investigator
BrighamHospital/CHUV
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing propofol and thiopental/pentobarbital in people with Status Epilepticus, run by Brigham and Women's Hospital at 5 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 1 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: stopped early, as of the sponsor's last update on 9 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Switzerland, 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 4 Apr 2013). 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?
Refractory Status Epilepticus Controlled With First Course of Study Drug (time frame: after return of continuous EEG activity (typically after 36 hours - 5 days)). 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 NCT00265616, which also lists 1 linked publication.
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 9 Apr 2013.