Epilepsy Clinical Trial
Official title:
Efficacy of Phosphatidylserine Enriched With Polyunsaturated n-3 Fatty Acid Supplementation on Attention Deficit Disorders in Children With Epilepsy. A Randomized Double-blind Placebo-controlled Trial
Our project aims to develop a new therapeutic approach in epilepsy-associated attention
disorders in children, through evaluation of the clinical impact of dietary n-3 fatty acids,
containing eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) conjugated to a
phospholipid vector. The primary objective is to evaluate the efficacy of a PUFA
supplementation (PS-Omega 3), after 12 weeks of treatment, on attention disorders in children
with epilepsy. Secondary objectives include:
- To evaluate the impact of a supplementation of PS-Omega 3 on quality of life.
- To evaluate the impact of a supplementation of PS-Omega 3 on serum and erythrocyte lipid
profiles.
- To assess the tolerance of a supplementation of PS-Omega 3.
- To assess the impact of a supplementation of PS-Omega 3 on the frequency of seizures.
- To describe the impact of a supplementation of PS-Omega 3, at 24 weeks,
1. on attention disorders in children with epilepsy,
2. on quality of life,
3. and on serum and erythrocyte lipid profiles. This study will recruit 272 subjects
aged 6- 16 years, suffering from epilepsy (any type) and attention deficit
hyperactivity disorder (ADHD) (inattentive or combined type) according to DSM V
criteria in 12 clinical sites in France.
n/a
| 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 |
NCT02952456 -
Phenomenological Approach of Epilepsy in Patients With Epilepsy
|
||
| Completed |
NCT02977208 -
Impact of Polymorphisms of OCT2 and OCTN1 on the Kinetic Disposition of Gabapentin in Patients Undergoing Chronic Use
|
Phase 4 | |
| 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 | |
| Completed |
NCT02491073 -
Study to Evaluate Serum Free Thyroxine (FT4) and Free Triiodothyronine (FT3) Measurements for Subjects Treated With Eslicarbazeine Acetate (ESL)
|
N/A | |
| Terminated |
NCT02757547 -
Transcranial Magnetic Stimulation for Epilepsy
|
N/A |