- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00362141
Safety and Tolerability Study of Levetiracetam to Treat Patients With Status Epilepticus
30. marts 2007 opdateret af: Medical Center Haaglanden
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.
Studieoversigt
Status
Ukendt
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding
12
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Charles Vecht, MD
- Telefonnummer: +31-70-3302508
- E-mail: c.vecht@mchaaglanden.nl
Undersøgelse Kontakt Backup
- Navn: Joris Uges, Pharmacist
- Telefonnummer: +31-70-3217217
- E-mail: j.uges@mchaaglanden.nl
Studiesteder
-
-
South-Holland
-
The Hague, South-Holland, Holland, 2512VA
- Rekruttering
- Medical Centre Haaglanden
-
Kontakt:
- Joris Uges, Pharmacist
- Telefonnummer: +31-70-3217217
- E-mail: j.uges@mchaaglanden.nl
-
Kontakt:
- Erik Wilms, Pharm D
- Telefonnummer: +31-70-3303131
- E-mail: e.wilms@mchaaglanden.nl
-
Ledende efterforsker:
- Charles Vecht, MD, PhD
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Woman < 50 years of age, without information on pregnancy
- Known pregnancy
- Known allergy for levetiracetam
- Daily dose levetiracetam of more than 2000mg/day
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
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o Uneventful intravenous (iv) administration of study medication
|
o Toxicity profile on iv administration, including:
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§ Irritation on injection site
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§ 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
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§ Allergic reactions, like skin rash
|
§ Other side-effects
|
Sekundære resultatmål
Resultatmål |
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Pharmacokinetic parameters of levetiracetam and clonazepam in patients with SE
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Charles Vecht, MD, PhD, Medical Centre Haaglanden
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. oktober 2006
Studieafslutning (Forventet)
1. april 2008
Datoer for studieregistrering
Først indsendt
8. august 2006
Først indsendt, der opfyldte QC-kriterier
8. august 2006
Først opslået (Skøn)
9. august 2006
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
2. april 2007
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
30. marts 2007
Sidst verificeret
1. marts 2007
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 06-013
- METC 06-013
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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-
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-
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-
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