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Sponsors and Collaborators: |
Medical Center Haaglanden UCB |
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Information provided by: | Medical Center Haaglanden |
ClinicalTrials.gov Identifier: | NCT00362141 |
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.
Condition | Intervention | Phase |
---|---|---|
Status Epilepticus |
Drug: levetiracetam (add-on) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | Safety and Tolerability of Add-on Levetiracetam in Status Epilepticus |
Estimated Enrollment: | 12 |
Study Start Date: | October 2006 |
Estimated Study Completion Date: | April 2008 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Charles Vecht, MD | +31-70-3302508 | c.vecht@mchaaglanden.nl |
Contact: Joris Uges, Pharmacist | +31-70-3217217 | j.uges@mchaaglanden.nl |
Netherlands, South-Holland | |
Medical Centre Haaglanden | Recruiting |
The Hague, South-Holland, Netherlands, 2512VA | |
Contact: Joris Uges, Pharmacist +31-70-3217217 j.uges@mchaaglanden.nl | |
Contact: Erik Wilms, Pharm D +31-70-3303131 e.wilms@mchaaglanden.nl | |
Principal Investigator: Charles Vecht, MD, PhD |
Principal Investigator: | Charles Vecht, MD, PhD | Medical Centre Haaglanden |
Study ID Numbers: | 06-013, METC 06-013 |
Study First Received: | August 8, 2006 |
Last Updated: | March 30, 2007 |
ClinicalTrials.gov Identifier: | NCT00362141 History of Changes |
Health Authority: | Netherlands: Medicines Evaluation Board (MEB) |
levetiracetam status epilepticus |
Nootropic Agents Epilepsy Status Epilepticus Central Nervous System Diseases |
Etiracetam Brain Diseases Anticonvulsants |
Nootropic Agents Epilepsy Therapeutic Uses Status Epilepticus Nervous System Diseases Central Nervous System Diseases |
Etiracetam Brain Diseases Central Nervous System Agents Pharmacologic Actions Anticonvulsants |