Epilepsy Clinical Trial
Official title:
Effects of Adjunctive Lacosamide on Mood States and Quality of Life (QOL) in Patients With Epilepsy
The purpose of this study is to determine the effect of lacosamide on mood and quality of life in people with epilepsy.
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.
;
Observational Model: Case Control, Time Perspective: Prospective
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04595513 -
Stopping TSC Onset and Progression 2: Epilepsy Prevention in TSC Infants
|
Phase 1/Phase 2 | |
| Completed |
NCT02909387 -
Adapting Project UPLIFT for Blacks in Georgia
|
N/A | |
| Completed |
NCT05552924 -
Self Acupressure on Fatigue and Sleep Quality in Epilepsy Patients
|
N/A | |
| Terminated |
NCT01668654 -
Long-term, Open-label Safety Extension Study of Retigabine/Ezogabine in Pediatric Subjects (>= 12 Years Old) With POS or LGS
|
Phase 3 | |
| Not yet recruiting |
NCT05068323 -
Impact of Interictal Epileptiform Activity on Some Cognitive Domains in Newly Diagnosed Epileptic Patients
|
N/A | |
| Completed |
NCT03994718 -
Creative Arts II Study
|
N/A | |
| Recruiting |
NCT04076449 -
Quantitative Susceptibility Biomarker and Brain Structural Property for Cerebral Cavernous Malformation Related Epilepsy
|
||
| Completed |
NCT00782249 -
Trial Comparing Different Stimulation Paradigms in Patients Treated With Vagus Nerve Stimulation for Refractory Epilepsy
|
N/A | |
| Completed |
NCT03683381 -
App-based Intervention for Treating Insomnia Among Patients With Epilepsy
|
N/A | |
| Recruiting |
NCT05101161 -
Neurofeedback Using Implanted Deep Brain Stimulation Electrodes
|
N/A | |
| Active, not recruiting |
NCT06034353 -
Impact of Pharmacist-led Cognitive Behavioral Intervention on Adherence and Quality of Life of Epileptic Patients
|
N/A | |
| Recruiting |
NCT05769933 -
Bridging Gaps in the Neuroimaging Puzzle: New Ways to Image Brain Anatomy and Function in Health and Disease Using Electroencephalography and 7 Tesla Magnetic Resonance Imaging
|
||
| Not yet recruiting |
NCT06408428 -
Glioma Intraoperative MicroElectroCorticoGraphy
|
N/A | |
| Not yet recruiting |
NCT05559060 -
Comorbidities of Epilepsy(Cognitive and Psychiatric Dysfunction)
|
||
| Completed |
NCT02977208 -
Impact of Polymorphisms of OCT2 and OCTN1 on the Kinetic Disposition of Gabapentin in Patients Undergoing Chronic Use
|
Phase 4 | |
| Completed |
NCT02952456 -
Phenomenological Approach of Epilepsy in Patients With Epilepsy
|
||
| Completed |
NCT02646631 -
Behavioral and Educational Tools to Improve Epilepsy Care
|
N/A | |
| Recruiting |
NCT02539134 -
TAK-935 Multiple Rising Dose Study in Healthy Participants
|
Phase 1 | |
| Terminated |
NCT02757547 -
Transcranial Magnetic Stimulation for Epilepsy
|
N/A | |
| Completed |
NCT02491073 -
Study to Evaluate Serum Free Thyroxine (FT4) and Free Triiodothyronine (FT3) Measurements for Subjects Treated With Eslicarbazeine Acetate (ESL)
|
N/A |