Effects of Adjunctive Lacosamide on Mood States and Quality of Life (QOL) in Patients With Epilepsy
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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New York
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Brooklyn, New York, Forenede Stater, 11203
- SUNY downstate Medical Center
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
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
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Change from baseline in overall Quality of Life in Epilepsy-89 (QOLIE-89) score
Tidsramme: 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
Tidsramme: baseline and 3 months later
|
baseline and 3 months later
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Change from baseline in QOLIE-89 subtests
Tidsramme: baseline and 3 months later
|
baseline and 3 months later
|
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Change from baseline in POMS subtests
Tidsramme: baseline and 3 months later
|
baseline and 3 months later
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Arthur C Grant, MD, PhD, State University of New York - Downstate Medical Center
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 11-011
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Kliniske forsøg med Epilepsi
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Boston Children's HospitalRekrutteringEpilepsi | Bevægelsesforstyrrelser | Dyskinesier | Ataksi | Neurologisk lidelse | Chorea | Myoklonus | Dyskinesi | Dystoni lidelse | Epilepsi hos børn | EDS | Bevægelsesforstyrrelser hos børn | Epilepsy-dyskinesi | Epilepsi-dyskinesi synkdomForenede Stater