Effects of Adjunctive Lacosamide on Mood States and Quality of Life (QOL) in Patients With Epilepsy
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
Lacosamide (LCM) was found in phase 3 studies to have good efficacy and tolerability as adjunctive treatment in adult patients with uncontrolled partial onset seizures, with or without secondary generalization. Dose-related adverse drug reactions (ADRs) included dizziness, headache and nausea, but the incidence of reported mood symptoms was similar to placebo. The very low incidence of such events, combined with LCM's unique mechanism of action, suggest that LCM has the potential to be among the few anti-epileptic drugs (AEDs) without clinically significant mood ADRs.
The effects of LCM on mood states (i.e., worsening or improvement) have not been examined with standardized measures. In addition, its effects on quality of life (QOL) have not been explored, although QOL is known to be affected by other AEDs.
The investigators propose to examine the effects of LCM on mood and QOL in a real-world population of adult patients with partial-onset seizures. To the knowledge of the investigators, the proposed study will be the first to examine these domains in a scientifically rigorous fashion in patients treated with LCM. Thus, study results will fill a current knowledge gap, and will provide important information to clinicians and patients when considering LCM treatment.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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New York
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Brooklyn, New York, Stati Uniti, 11203
- SUNY downstate Medical Center
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- At least 17 years old
- Have partial (focal) onset seizures that are not controlled with medication
- (LCM group only) LCM is being added to anti-epileptic drug regimen by treating physician
Exclusion Criteria:
- Have taken LCM in the past.
- Change in anti-epileptic drugs or their doses in the past 28 days.
- Have participated in another drug research study in the past 3 months.
- Have had epilepsy brain surgery, or plan to have epilepsy surgery in the next four months.
- Have a psychiatric or behavioral condition, which in the opinion of the investigator, could compromise patient's ability to participate in the study.
- Have a progressive (worsening) disease that affects patients brain and its functions.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
|---|
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LCM group
Patients who are having lacosamide (LCM) added to their anti-epileptic drug regimen
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control group
Patients who are NOT having lacosamide (LCM) added to their anti-epileptic drug regimen
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Change from baseline in overall Quality of Life in Epilepsy-89 (QOLIE-89) score
Lasso di tempo: baseline and 3 months later
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baseline and 3 months later
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Change from baseline in Profile of Mood States (POMS) score
Lasso di tempo: baseline and 3 months later
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baseline and 3 months later
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Change from baseline in QOLIE-89 subtests
Lasso di tempo: baseline and 3 months later
|
baseline and 3 months later
|
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Change from baseline in POMS subtests
Lasso di tempo: baseline and 3 months later
|
baseline and 3 months later
|
Collaboratori e investigatori
Collaboratori
Investigatori
- Investigatore principale: Arthur C Grant, MD, PhD, State University of New York - Downstate Medical Center
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 11-011
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