Ignite Creation Date:
2024-05-06 @ 7:03 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05881928
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-07-21
First Post:
2023-03-21
Brief Title:
Effect of Adding Lamotrigine to Sodium Valproate in Childhood Epilepsy Clinicolabratory Study
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
Effect of Adding Lamotrigine to Sodium Valproate in Childhood Epilepsy Clinicolabratory Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Epilepsy is one of the most common serious chronic brain disorders of childhood The causes of epilepsy include acquired brain damage altered metabolic states inborn brain malformations and genetic causes At present antiepileptic drugs AEDs are the first line therapy for resistant epilepsy RE and the second line is surgery and vagus nerve stimulation Sodium valproate SV is a first line anti epileptic drug that can be applied to various seizure types in children SV has anticonvulsant activity through regulation of neuronal pathways It has a molecular structure similar to neurotransmitter γ aminobutyric acid GABA resulting in GABA synergism A serious adverse effect of the valproic acid VPA is its effect on liver function with resultant drug-induced hepatotoxicity hyperammonemia Lamotrigine LTG is a second generation AED
LTG belongs to the sodium channel blocking class of antiseizure medications ASMs Lamortigine side effects include severe rash fever lymphadenopathy hepatic dysfunction blood disorderand disseminated intravascular coagulation and Stevens-Johnson syndrome SJS the aim Evaluation of the efficacy and safety of adding lamotrigine to sodium valproate in epileptic children not responding to SV alone for 6 months Moreover the investigators will evaluate the effects of this addition appearance of side effectslaboratory evaluation and EEG changes 50 epileptic patients receive SV for 6 months without complete remission for participants the investigators will add lamotrigine for 6 months
LTG belongs to the sodium channel blocking class of antiseizure medications ASMs Lamortigine side effects include severe rash fever lymphadenopathy hepatic dysfunction blood disorderand disseminated intravascular coagulation and Stevens-Johnson syndrome SJS the aim Evaluation of the efficacy and safety of adding lamotrigine to sodium valproate in epileptic children not responding to SV alone for 6 months Moreover the investigators will evaluate the effects of this addition appearance of side effectslaboratory evaluation and EEG changes 50 epileptic patients receive SV for 6 months without complete remission for participants the investigators will add lamotrigine for 6 months
Detailed Description:
Epilepsy is one of the most common serious chronic brain disorders of childhood It is characterized by recurrent seizures that can cause motor sensory cognitive psychic or autonomic disturbances It has a negative impact on 06 of the population in developed countries and 16 in developing countries The causes of epilepsy include acquired brain damage altered metabolic states inborn brain malformations and genetic causes At present antiepileptic drugs AEDs are the first line therapy for resistant epilepsy RE and the second line is surgery and vagus nerve stimulation Although the treatment for RE has been continuously updated the exploration of high efficacy AED combinations is still ongoing Sodium valproate SV is a first line anti epileptic drug that can be applied to various seizure types in children SV has anticonvulsant activity through regulation of neuronal pathways It has a molecular structure similar to neurotransmitter γ aminobutyric acid GABA resulting in GABA synergism A serious adverse effect of the valproic acid VPA is its effect on liver function with resultant drug-induced hepatotoxicity hyperammonemia Lamotrigine LTG is a second generation AED and also has the function of resisting depression and stabilizing mood It is applicable for children and adolescents with various seizure types and syndromes due to its good anticonvulsant tolerance broad spectrum activity and safety LTG belongs to the sodium channel blocking class of antiseizure medications ASMs Lamortigine side effects include severe rash fever lymphadenopathy hepatic dysfunction blood disorderand disseminated intravascular coagulation and Stevens-Johnson syndrome SJS has also been mentioned as a rare hypersensitivity reaction The aim Evaluation of the efficacy and safety of adding lamotrigine to sodium valproate in epileptic children not responding to SV alone for 6 months Moreover the investigators will evaluate the effects of this addition appearance of side effectslaboratory evaluation and EEG changes 50 epileptic patients receive SV for 6 months without complete remission for participants Investigators will add lamotrigine for 6 months Setting single -center study with outpatient from University Childrens Hospital Faculty of Medicine Assuit University Design of this study - Cross -sectional interventional Selected patient for this study will receive additional treatment of LTG with SV for 6 month
Doses of the drugs Sodium valproate 30 mg kg day maximum dose 1500mg day LTG will be initiated at a daily dose of 05 mgkg for 2 weeks in two divided doses followed by 10 mgkgday for an additional 2 weeksfollowed by 15mgkgday for additional 2weeks Thereafter doses will be increased in 05mgkgday increments every 2weeks until intolerable adverse effects occurred or a maximum dose of 3mgkgday will be reached
The outcome measures
The outcome measures will be 1Clinical measures -patient will be clinically examined For side effectsbody weight muscle weakness ataxia hair loss - The seizure frequency before and after adding lamotrigine the investigators will exclude patient with allergy to LTG after the first 2 weeks of treatment
2- Laboratory measures - -Serum concentration of lamotrigine at the end of study - The incidence of adverse reactions will be assessed by lab tests as 1 liver function tests 2serum ammonia 3 coagulation function 4 complete blood count 3-Neurophysological evaluation-EEG will be done at the beginning and end of the study
Inclusion criteria 1 Male or female ages 2 - 12years
2 50 epileptic children on sodium valproate for 6 months without complete remission
Exclusion Criteria
Subjects will be excluded if any of the following criteria are met-
1 Suspected other neurological disorders
2 Allergic to LTG
3 Liver dysfunction
4 kidney dysfunction
5 Not cooperating with this study
Doses of the drugs Sodium valproate 30 mg kg day maximum dose 1500mg day LTG will be initiated at a daily dose of 05 mgkg for 2 weeks in two divided doses followed by 10 mgkgday for an additional 2 weeksfollowed by 15mgkgday for additional 2weeks Thereafter doses will be increased in 05mgkgday increments every 2weeks until intolerable adverse effects occurred or a maximum dose of 3mgkgday will be reached
The outcome measures
The outcome measures will be 1Clinical measures -patient will be clinically examined For side effectsbody weight muscle weakness ataxia hair loss - The seizure frequency before and after adding lamotrigine the investigators will exclude patient with allergy to LTG after the first 2 weeks of treatment
2- Laboratory measures - -Serum concentration of lamotrigine at the end of study - The incidence of adverse reactions will be assessed by lab tests as 1 liver function tests 2serum ammonia 3 coagulation function 4 complete blood count 3-Neurophysological evaluation-EEG will be done at the beginning and end of the study
Inclusion criteria 1 Male or female ages 2 - 12years
2 50 epileptic children on sodium valproate for 6 months without complete remission
Exclusion Criteria
Subjects will be excluded if any of the following criteria are met-
1 Suspected other neurological disorders
2 Allergic to LTG
3 Liver dysfunction
4 kidney dysfunction
5 Not cooperating with this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None