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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,
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PS-OMEGA 3, capsules twice daily | Active Comparator | Vayarin®, supplementation of n-3 PUFA: each capsule contains 8.5 mg of docosahexaenoic acid (DHA), 21.5 mg of eicosapentaenoic acid (EPA) and 75 mg of phosphatidylserine. |
|
| PLACEBO, capsules twice daily | Placebo Comparator | The placebo will be made of cellulose and a small amount of fish powder to maintain the double-blind in odor and taste. The supplementation in n-3 PUFA in the placebo group may be considered as negligible. Placebo will be administered as indistinguishable capsules, identical to the active product. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vayarin®, supplementation of n-3 PUFA | Drug | Two capsules will be swallowed twice daily, 20 to 30 minutes prior to breakfast and dinner, during 12 weeks, between visit 1 and visit 2. At the end of this period, active product will be continued, at the same dose, for a 12 week-open label period. All patients will be administered the active product. |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of the ADHD-rating scale IV inattentive subscore in subjects assigned to supplementation of PS-Omega 3 in comparison with the placebo group after 12 weeks of treatment. | The ADHD Rating Scale-IV quantifies each of the 18 symptoms of ADHD on a 0 to 3 scale, with a maximum score of 54 points. Nine of the 18 items score for inattention while the nine others assess hyperactivity with a maximum of 27 points each. The discriminative value of these two subscales was validated, allowing their individual use. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of the ADHD Rating Scale-IV total score in the PS-Omega 3 group compared with the placebo group after 12 weeks of treatment. | The ADHD Rating Scale-IV quantifies each of the 18 symptoms of ADHD on a 0 to 3 scale, with a maximum score of 54 points. | 12 weeks |
| Reduction of TOVA total score in the PS-Omega 3 group compared with the placebo group after 12 weeks of treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sylvain Rheims, MD | Hospices Civils de Lyon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Amiens | Amiens | France | ||||
| CHU d'Angers |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38173190 | Result | Rheims S, Herbillon V, Gaillard S, Mercier C, Villeuve N, Villega F, Cances C, Castelnau P, Napuri S, de Saint-Martin A, Auvin S, Nguyen The Tich S, Berquin P, de Bellecize J, Milh M, Roy P, Arzimanoglou A, Bodennec J, Bezin L, Kassai B; investigators of the AGPI study group. Phosphatidylserine enriched with polyunsaturated n-3 fatty acid supplementation for attention-deficit hyperactivity disorder in children and adolescents with epilepsy: A randomized placebo-controlled trial. Epilepsia Open. 2024 Apr;9(2):582-591. doi: 10.1002/epi4.12892. Epub 2024 Jan 25. | |
| 37058600 |
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|
| PLACEBO | Drug | Two capsules will be swallowed twice daily, 20 to 30 minutes prior to breakfast and dinner, during 12 weeks, between visit 1 and visit 2. |
|
The TOVA (Test of Variables of Attention) is a computerized tool assessing the capacity of attention and impulse control. This test has been validated as a diagnostic tool in ADHD. |
| 12 weeks |
| Proportion of subjects with a normalized TOVA score in the PS-Omega 3 group compared with the placebo group after 12 weeks of treatment. | The TOVA (Test of Variables of Attention) is a computerized tool assessing the capacity of attention and impulse control. This test has been validated as a diagnostic tool in ADHD. | 12 weeks |
| Change in quality of life score in the PS-Omega 3 group compared with the placebo group after 12 weeks of treatment. | Quality of life assessed by the EFIQUACEE questionnaire (Echelle Française d'Impact et de Qualité de Vie Chez l'Enfant atteint d'Epilepsie). The EFIQUACEE questionnaire is a unique quality of life scale for children suffering from epilepsy. It is validated in French language. | 12 weeks |
| Evolution of plasma lipid profiles in subjects assigned to supplementation of PS-Omega 3 in comparison with the placebo group after 12 weeks of treatment. | Plasma levels before and after 12 weeks of treatment: total lipid mass ; total phospholipids ; individual phospholipids including: lysophosphatidylcholin, phosphatidylcholin, sphingomyelin, phosphatidylserine, phosphatidylinositol, phosphatidylethanolamine, diphosphatidylglycerol, lysophosphatidylethanolamine ; total triglycerides ; fatty acids profiles in phospholipids; fatty acids profiles in triglycerides ; fatty acids profiles in cholesterol esters. | 12 weeks |
| Evolution of eythrocytes lipid profiles in subjects assigned to supplementation of PS-Omega 3 in comparison with the placebo group after 12 weeks of treatment. | Quantification of, in erythrocyte membrane, before and after 12 weeks of treatment: total lipid mass ; total phospholipids ; individual phospholipids including: lysophosphatidylcholin, phosphatidylcholin, sphingomyelin, phosphatidylserine, phosphatidylinositol, phosphatidylethanolamine, diphosphatidylglycerol, lysophosphatidylethanolamine ; total triglycerides ; fatty acids profiles in phospholipids; fatty acids profiles in triglycerides ; fatty acids profiles in cholesterol esters. | 12 weeks |
| Tolerance of a supplementation of PS-Omega 3. | Tolerance analysis of the supplementation of PS-Omega 3: interrogatoire, phone calls, clinical examinations, adverse events reported throughout the study. | 36 weeks |
| Number of subjects with a reduction in the frequency of seizures ≥ 50%, in the PS-Omega 3 group compared with the placebo group after 12 weeks of treatment. | 12 weeks |
| After 24 weeks of treatment, description of the total score of ADHD Rating Scale. | 24 weeks |
| After 24 weeks of treatment, description of the total score of TOVA. | 24 weeks |
| After 24 weeks of treatment, proportion of subjects with a normalized TOVA score. | 24 weeks |
| After 24 weeks of treatment, change in quality of life score (EFIQUACEE questionnaire). | 24 weeks |
| After 24 weeks of treatment, plasma lipid levels before and after treatment. | Plasma levels before and after 24 weeks of treatment: total lipid mass ; total phospholipids ; individual phospholipids including: lysophosphatidylcholin, phosphatidylcholin, sphingomyelin, phosphatidylserine, phosphatidylinositol, phosphatidylethanolamine, diphosphatidylglycerol, lysophosphatidylethanolamine ; total triglycerides ; fatty acids profiles in phospholipids; fatty acids profiles in triglycerides ; fatty acids profiles in cholesterol esters. | 24 weeks |
| After 24 weeks of treatment, erythrocyte lipid levels before and after treatment. | Quantification of, in erythrocyte membrane, before and after 24 weeks of treatment: total lipid mass ; total phospholipids ; individual phospholipids including: lysophosphatidylcholin, phosphatidylcholin, sphingomyelin, phosphatidylserine, phosphatidylinositol, phosphatidylethanolamine, diphosphatidylglycerol, lysophosphatidylethanolamine ; total triglycerides ; fatty acids profiles in phospholipids; fatty acids profiles in triglycerides ; fatty acids profiles in cholesterol esters. | 24 weeks |
| Angers |
| France |
| Hôpital des Enfants - Pellegrin | Bordeaux | France |
| CHRU Lille | Lille | France |
| Hospices Civils de Lyon | Lyon | France |
| Hôpital de la Timone | Marseille | France |
| Hôpital Necker-Enfants malades | Paris | France |
| Hôpital Robert-Debré | Paris | France |
| CHU de Rennes | Rennes | France |
| Hôpital de Hautepierre | Strasbourg | France |
| CHU de Toulouse | Toulouse | France |
| CHU de Tours | Tours | France |
| Hôpital Brabois - Rue du Morvan | Vandœuvre-lès-Nancy | France |
| Derived |
| Gillies D, Leach MJ, Perez Algorta G. Polyunsaturated fatty acids (PUFA) for attention deficit hyperactivity disorder (ADHD) in children and adolescents. Cochrane Database Syst Rev. 2023 Apr 14;4(4):CD007986. doi: 10.1002/14651858.CD007986.pub3. |
| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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