Status EpilepticusPhase 2NCT00362141
Safety and Tolerability Study of Levetiracetam to Treat Patients With Status Epilepticus
A Phase 2 study testing levetiracetam (add-on) in people with Status Epilepticus, run by Medical Center Haaglanden at 1 site in Netherlands.
Trial summary
The purpose of this study is to determine whether levetiracetam is safe and well tolerated by patients while suffering a status epilepticus. Levetiracetam is added to the standard treatment of patients with this disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Status Epilepticus
- What is being tested?
- levetiracetam (add-on)
- How many people
- 12 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2006to Apr 2008
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: ≥18 years of age
- All types of SE, diagnosed by the medical examiner according to the predefined definition. Absence SE has to be confirmed by EEG.
- Woman: 18-50 years of age of whom is known, from anamnesis or hetero-anamnesis (first line relative), that she is not pregnant.
Who cannot join
- Woman < 50 years of age, without information on pregnancy
- Known pregnancy
- Known allergy for levetiracetam
- Daily dose levetiracetam of more than 2000mg/day
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Medical Centre Haaglanden
The Hague, South Holland, 2512VA
Joris Uges, Pharmacist, +31-70-3217217, j.uges@mchaaglanden.nl
Erik Wilms, Pharm D, +31-70-3303131, e.wilms@mchaaglanden.nl
About this study
Official title: Safety and Tolerability of Add-on Levetiracetam in Status Epilepticus
The purpose of this study is to determine whether levetiracetam is safe and well tolerated by patients while suffering a status epilepticus. Levetiracetam is added to the standard treatment of patients with this disease.
Read the detailed description
Status epilepticus (SE) is a disorder with high mortality and morbidity. There are strong indications that ongoing seizure activity substantially reduces the chances on a good outcome. This implies that optimal treatment of SE should start as soon as possible. Unfortunately, treatment options are limited and often based on little evidence. Besides, current treatment options are hampered by serious side-effects like respiratory depression and impaired consciousness. Therefore, the advent of new and effective anti-epileptic drugs (AEDs) is of great potential interest for the treatment of SE. Presently, the newer AEDs are mainly used in later stages of SE at a time when the disease is often more difficult to control. The characteristics of one of these recently introduced anticonvulsants i.e. levetiracetam seems to provide a number of fortunate properties for application as first-line treatment of SE. The complicating side-effects of "classical" AEDs, like a decrease in cardiorespiratory function or in level of consciousness are hardly present. Besides, levetiracetam may lower the need for benzodiazepines, reducing chances on respiratory depression by benzodiazepines at higher doses. Due to a remarkable synergism with first-line administered benzodiazepines, levetiracetam may therefore reduce the need for intubation or ICU treatment. Besides, it may enhance the immediate cessation of seizures, prolong the anti-seizure activity of benzodiazepines and provide neuroprotective properties. The sustained efficacy of levetiracetam would suggest that long term sequelae secondary to neurological damage, may also be reduced. Levetiracetam IV has recently been shown to be safe in healthy volunteers, and becomes available for iv application in clinical practice, early 2006. To date, there are hardly any data available on its applicability in medical emergencies like SE. We propose as a first step the executing of a phase II study on tolerability and safety of intravenous levetiracetam in patients with SE. Current first-line treatment of SE consists of standardized administration of benzodiazepines. For the study we propose to apply this regimen together with the iv administration of levetiracetam as add-on therapy.
- Conditions
- Status Epilepticus
- Being tested
- levetiracetam (add-on)
- Keywords
- levetiracetam, status, epilepticus
- Medical subject headings
- Status Epilepticus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
levetiracetam (add-on)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
o Uneventful intravenous (iv) administration of study medication
o Toxicity profile on iv administration, including:
§ Irritation on injection site
§ Hypotension, defined as systolic blood pressure below 90 mm Hg recorded within 24 hours of the dose
§ Cardiac arrest (diagnosed clinically) or bradyarrhythmias including heart block, documented on an electrocardiogram
§ Respiratory depression, defined as the occurrence of apnea or need for intubation
§ Allergic reactions, like skin rash
§ Other side-effects
Secondary outcomes (1)
Pharmacokinetic parameters of levetiracetam and clonazepam in patients with SE
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2006 (estimated)
- Study startOct 2006
- Study completionApr 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Status EpilepticusStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants
Sponsor and investigators
- Lead sponsor
- Medical Center Haaglanden
- Sponsor type
- University, hospital or other
- Collaborators
- UCB Pharma
- Investigators
- Charles Vecht, MD, PhD, Principal investigator, Medical Centre Haaglanden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00362141
- Sponsor's protocol ID
- 06-013
- Other IDs
- METC 06-013
- Status last verified
- Mar 2007
- First submitted
- 8 Aug 2006
- Last updated
- 2 Apr 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Tolerability of Add-on Levetiracetam in Status Epilepticus
- ClinicalTrials.gov ID
- NCT00362141
- Acronym / sponsor ID
- 06-013
- Conditions
- Status Epilepticus
- Keywords
- levetiracetam, status, epilepticus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants
- Lead sponsor
- Medical Center HaaglandenUniversity, hospital or other
- Collaborators
- UCB Pharma
- Study start
- Oct 2006
- Study completion
- Apr 2008 (estimated)
- First posted
- 9 Aug 2006 (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.
The purpose of this study is to determine whether levetiracetam is safe and well tolerated by patients while suffering a status epilepticus. Levetiracetam is added to the standard treatment of patients with this disease.
Detailed description
Status epilepticus (SE) is a disorder with high mortality and morbidity. There are strong indications that ongoing seizure activity substantially reduces the chances on a good outcome. This implies that optimal treatment of SE should start as soon as possible. Unfortunately, treatment options are limited and often based on little evidence. Besides, current treatment options are hampered by serious side-effects like respiratory depression and impaired consciousness. Therefore, the advent of new and effective anti-epileptic drugs (AEDs) is of great potential interest for the treatment of SE. Presently, the newer AEDs are mainly used in later stages of SE at a time when the disease is often more difficult to control. The characteristics of one of these recently introduced anticonvulsants i.e. levetiracetam seems to provide a number of fortunate properties for application as first-line treatment of SE. The complicating side-effects of "classical" AEDs, like a decrease in cardiorespiratory function or in level of consciousness are hardly present. Besides, levetiracetam may lower the need for benzodiazepines, reducing chances on respiratory depression by benzodiazepines at higher doses. Due to a remarkable synergism with first-line administered benzodiazepines, levetiracetam may therefore reduce the need for intubation or ICU treatment. Besides, it may enhance the immediate cessation of seizures, prolong the anti-seizure activity of benzodiazepines and provide neuroprotective properties. The sustained efficacy of levetiracetam would suggest that long term sequelae secondary to neurological damage, may also be reduced. Levetiracetam IV has recently been shown to be safe in healthy volunteers, and becomes available for iv application in clinical practice, early 2006. To date, there are hardly any data available on its applicability in medical emergencies like SE. We propose as a first step the executing of a phase II study on tolerability and safety of intravenous levetiracetam in patients with SE. Current first-line treatment of SE consists of standardized administration of benzodiazepines. For the study we propose to apply this regimen together with the iv administration of levetiracetam as add-on therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age: ≥18 years of age
- All types of SE, diagnosed by the medical examiner according to the predefined definition. Absence SE has to be confirmed by EEG.
- Woman: 18-50 years of age of whom is known, from anamnesis or hetero-anamnesis (first line relative), that she is not pregnant.
Key exclusion criteria (4 listed)
- Woman < 50 years of age, without information on pregnancy
- Known pregnancy
- Known allergy for levetiracetam
- Daily dose levetiracetam of more than 2000mg/day
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 |
|---|---|---|
| levetiracetam (add-on) | Drug | – |
Primary outcome
o Uneventful intravenous (iv) administration of study medication
o Toxicity profile on iv administration, including:
§ Irritation on injection site
§ Hypotension, defined as systolic blood pressure below 90 mm Hg recorded within 24 hours of the dose
§ Cardiac arrest (diagnosed clinically) or bradyarrhythmias including heart block, documented on an electrocardiogram
§ Respiratory depression, defined as the occurrence of apnea or need for intubation
§ Allergic reactions, like skin rash
§ Other side-effects
1 secondary outcome
Pharmacokinetic parameters of levetiracetam and clonazepam in patients with SE
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2007.
- CCMOLink provided by the sponsor.
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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.
Charles Vecht, MD, PhD principal investigator
Medical Centre Haaglanden
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 levetiracetam (add-on) in people with Status Epilepticus, run by Medical Center Haaglanden at 1 site in Netherlands.
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 4 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: status not confirmed, as of the sponsor's last update on 2 Apr 2007. 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 Netherlands. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Charles Vecht, MD (+31-70-3302508, c.vecht@mchaaglanden.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
o Uneventful intravenous (iv) administration of study medication. The study lists 8 primary outcomes in all. 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 2 Apr 2007.