Effects of Adjunctive Lacosamide on Mood States and Quality of Life (QOL) in Patients With Epilepsy
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
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New York
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Brooklyn, New York, Vereinigte Staaten, 11203
- SUNY Downstate Medical Center
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
|---|
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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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
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Change from baseline in overall Quality of Life in Epilepsy-89 (QOLIE-89) score
Zeitfenster: 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
Zeitfenster: baseline and 3 months later
|
baseline and 3 months later
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
Change from baseline in QOLIE-89 subtests
Zeitfenster: baseline and 3 months later
|
baseline and 3 months later
|
|
Change from baseline in POMS subtests
Zeitfenster: baseline and 3 months later
|
baseline and 3 months later
|
Mitarbeiter und Ermittler
Mitarbeiter
Ermittler
- Hauptermittler: Arthur C Grant, MD, PhD, State University of New York - Downstate Medical Center
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 11-011
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