EpilepsyPhase 4NCT05881928
Effect of Adding Lamotrigine to Sodium Valproate in Childhood Epilepsy: Clinicolabratory Study
A Phase 4 study testing Sodium Valproate 500 Mg Prolonged-Release Oral Tablet, Lamotrigine and E.E.G in people with Epilepsy and Lamotrigine, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Epilepsy, Lamotrigine, Sodium Valproate Adverse Reaction
- What is being tested?
- Sodium Valproate 500 Mg Prolonged-Release Oral Tablet, Lamotrigine and E.E.G
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 29 Jul 2024to Apr 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Male or female, ages 2 - 12years.
- 50 epileptic children on sodium valproate for 6 months without complete remission.
Who cannot join
- other neurological disorders .
- Allergic to LTG.
- Liver dysfunction.
- kidney dysfunction .
- Not cooperating with this study
Trial locations and contacts
No sites are listed yet.
About this study
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 disorder,and 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 effects,laboratory 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.
Read the 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 0.6% of the population in developed countries and 1.6% 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 disorder,and 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 effects,laboratory 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 Children's 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 0.5 mg/kg for 2 weeks in two divided doses, followed by 1.0 mg/kg/day for an additional 2 weeks,followed by 1.5mg/kg/day for additional 2weeks Thereafter, doses will be increased in 0.5mg/kg/day increments every 2weeks until intolerable adverse effects occurred, or a maximum dose of 3mg/kg/day will be reached .
The outcome measures :
The outcome measures will be . 1.Clinical measures: -patient will be clinically examined For side effects(body 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. 2.serum 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:-
- Suspected other neurological disorders .
- Allergic to LTG.
- Liver dysfunction.
- kidney dysfunction .
- Not cooperating with this study
- Conditions
- Epilepsy, Lamotrigine, Sodium Valproate Adverse Reaction
- Being tested
- Sodium Valproate 500 Mg Prolonged-Release Oral Tablet, Lamotrigine, E.E.G
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium Valproate 500 Mg Prolonged-Release Oral TabletDrug
sodium valproate tablet30 mg / kg / day , maximum 1500mg / day . LTG :
LamotrigineDrug
lamotrigine tablet 0.5 mg/kg for 2 weeks in two divided doses , increased in 0.5mg/kg/day increments every 2weeks .
E.E.GDevice
device recording of brain activity. During this painless test, small sensors are attached to the scalp to pick up the electrical signals produced by the brain. These signals are recorded by a machine and are looked at by a doctoris
| Study group | Role | What they receive |
|---|---|---|
| 50 epileptic patients receive SV for 6 months , for whom add lamotrigine for 6 month | Other | 50 epileptic patients receive SV for 6 months at dose 30 mg.kg.day, for whom add lamotrigine for 6 month at dose 0.5 mg.kg.day then add 0.5 mg.kg.day every 2 weeks Receives: Drug: Sodium Valproate 500 Mg Prolonged-Release Oral Tablet; Drug: Lamotrigine; Device: E.E.G |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
Weight in kilogramme will be measured in 50 participants
Measured: 6 months
Secondary outcomes (5)
liver function tests
blood tests that measure different enzymes, proteins, and other substances made by the liver.The liver function tests typically include alanine transaminase (ALT) and aspartate transaminase (AST), alkaline phosphatase (ALP), gamma-glutamyl transferase (GGT), serum bilirubin, prothrombin time (PT), the international normalized ratio (INR), total protein and albuminALT. 7 to 55 units per liter (U/L) AST. 8 to 48 U/L. ALP. 40 to 129 U/L. Albumin. 3.5 to 5.0 grams per deciliter (g/dL) Total protein. 6.3 to 7.9 g/dL. Bilirubin. 0.1 to 1.2 milligrams per deciliter (mg/dL) GGT. 8 to 61 U/L. LD. 122 to 222 U/L.
Measured: 6months
serum ammonia.
An ammonia test measures the amount of ammonia in the blood , Ammonia level normal range is usually :
170-340 mcg/dL in new-borns, 70-135 mcg/dL in children , Ammonia Colorimetric Assay Kit will be used for assessment of serum ammonia levels
Measured: 6months
complete blood count
complete blood count, or CBC, is a blood test that measures many different parts and features of blood, including red blood cells, white blood cells, and platelets
Measured: 6 months
E.E.G
E.E.G power in alpha band ,device recording of brain activity. During this painless test, small sensors are attached to the scalp to pick up the electrical signals produced by the brain. These signals are recorded by a machine and are looked at by a doctorisThe most commonly studied waveforms include delta (0.5 to 4Hz); theta (4 to 7Hz); alpha (8 to 12Hz); sigma (12 to 16Hz) and beta (13 to 30Hz). In addition, there are other waveforms such as infra slow oscillations (ISO) (less than 0.5Hz) and high-frequency oscillations (HFOs) (greater than 30Hz) which are outside the conventional bandwidth of clinical EEG but have recently found clinical importance with the adven
Measured: 6months
Serum concentration of LTG
The serum concentration should be interpreted in the context of the patient's clinical response and may provide useful information in patients showing poor response, noncompliance, or adverse effects, particularly when lamotrigine is coadministered with other epileptic drugs.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study start29 Jul 2024 (estimated)
- Primary completion30 Jul 2024
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mona Mohammed Abdellatief, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05881928
- Sponsor's protocol ID
- lamotrigine , sodium valproate
- Status last verified
- Jul 2024
- First submitted
- 21 Mar 2023
- Last updated
- 30 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Altunbasak S, Baytok V, Tasouji M, Herguner O, Burgut R, Kayrin L. Asymptomatic hyperammonemia in children treated with valproic acid. J Child Neurol. 1997 Oct;12(7):461-3. doi: 10.1177/088307389701200709. No abstract available.
PubMed 9373804Armeno M, Verini A, Del Pino M, Araujo MB, Mestre G, Reyes G, Caraballo RH. A Prospective Study on Changes in Nutritional Status and Growth Following Two Years of Ketogenic Diet (KD) Therapy in Children with Refractory Epilepsy. Nutrients. 2019 Jul 14;11(7):1596. doi: 10.3390/nu11071596.
PubMed 31337135Balagura G, Iapadre G, Verrotti A, Striano P. Moving beyond sodium valproate: choosing the right anti-epileptic drug in children. Expert Opin Pharmacother. 2019 Aug;20(12):1449-1456. doi: 10.1080/14656566.2019.1617850. Epub 2019 May 17.
PubMed 31099271Cavus I, Romanyshyn JC, Kennard JT, Farooque P, Williamson A, Eid T, Spencer SS, Duckrow R, Dziura J, Spencer DD. Elevated basal glutamate and unchanged glutamine and GABA in refractory epilepsy: Microdialysis study of 79 patients at the yale epilepsy surgery program. Ann Neurol. 2016 Jul;80(1):35-45. doi: 10.1002/ana.24673. Epub 2016 Jun 13.
PubMed 27129611Fassi G, Igoa A, Liste OA. [Valproate-induced hyperammonemic encephalopathy. Review of cases in the psychiatric setting]. Vertex. 2008 Nov-Dec;19(82):371-7. Spanish.
PubMed 19424520Deng J, Fu ZR, Wang L, Liu J, Chen CH, Fang F, Wang XL. Acute liver failure associated with lamotrigine in children with epilepsy: A report of two cases and thoughts on pharmacogenomics. Epilepsy Behav Rep. 2022 Oct 19;20:100568. doi: 10.1016/j.ebr.2022.100568. eCollection 2022.
PubMed 36345310Fu J, Peng L, Wang W, He H, Zeng S, Chen TC, Chen Y. Sodium Valproate Reduces Neuronal Apoptosis in Acute Pentylenetetrzole-Induced Seizures via Inhibiting ER Stress. Neurochem Res. 2019 Nov;44(11):2517-2526. doi: 10.1007/s11064-019-02870-w. Epub 2019 Sep 11.
PubMed 31512113Lheureux PE, Hantson P. Carnitine in the treatment of valproic acid-induced toxicity. Clin Toxicol (Phila). 2009 Feb;47(2):101-11. doi: 10.1080/15563650902752376.
PubMed 19280426Zhang D, Qiu L, Zhang Y, Sang Y, Zheng N, Liu X. Efficacy and safety of sodium valproate plus lamotrigine in children with refractory epilepsy. Exp Ther Med. 2020 Sep;20(3):2698-2704. doi: 10.3892/etm.2020.8984. Epub 2020 Jul 10.
PubMed 32765764Moosa ANV. Antiepileptic Drug Treatment of Epilepsy in Children. Continuum (Minneap Minn). 2019 Apr;25(2):381-407. doi: 10.1212/CON.0000000000000712.
PubMed 30921015
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Adding Lamotrigine to Sodium Valproate in Childhood Epilepsy: Clinicolabratory Study
- ClinicalTrials.gov ID
- NCT05881928
- Acronym / sponsor ID
- lamotrigine , sodium valproate
- Conditions
- Epilepsy, Lamotrigine, Sodium Valproate Adverse Reaction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 29 Jul 2024 (estimated)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- Apr 2025 (estimated)
- First posted
- 31 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 disorder,and 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 effects,laboratory 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 0.6% of the population in developed countries and 1.6% 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 disorder,and 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 effects,laboratory 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 Children's 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 0.5 mg/kg for 2 weeks in two divided doses, followed by 1.0 mg/kg/day for an additional 2 weeks,followed by 1.5mg/kg/day for additional 2weeks Thereafter, doses will be increased in 0.5mg/kg/day increments every 2weeks until intolerable adverse effects occurred, or a maximum dose of 3mg/kg/day will be reached .
The outcome measures :
The outcome measures will be . 1.Clinical measures: -patient will be clinically examined For side effects(body 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. 2.serum 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:-
- Suspected other neurological disorders .
- Allergic to LTG.
- Liver dysfunction.
- kidney dysfunction .
- Not cooperating with this study
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 50 epileptic patients receive SV for 6 months , for whom add lamotrigine for 6 month | Other | Drug: Sodium Valproate 500 Mg Prolonged-Release Oral Tablet, Drug: Lamotrigine, Device: E.E.G50 epileptic patients receive SV for 6 months at dose 30 mg.kg.day, for whom add lamotrigine for 6 month at dose 0.5 mg.kg.day then add 0.5 mg.kg.day every 2 weeks |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Male or female, ages 2 - 12years.
- 50 epileptic children on sodium valproate for 6 months without complete remission.
Key exclusion criteria (5 listed)
- other neurological disorders .
- Allergic to LTG.
- Liver dysfunction.
- kidney dysfunction .
- Not cooperating with this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium Valproate 500 Mg Prolonged-Release Oral Tabletsodium valproate tablet30 mg / kg / day , maximum 1500mg / day . LTG : | Drug | 50 epileptic patients receive SV for 6 months , for whom add lamotrigine for 6 month |
| Lamotriginelamotrigine tablet 0.5 mg/kg for 2 weeks in two divided doses , increased in 0.5mg/kg/day increments every 2weeks . | Drug | 50 epileptic patients receive SV for 6 months , for whom add lamotrigine for 6 month |
| E.E.Gdevice recording of brain activity. During this painless test, small sensors are attached to the scalp to pick up the electrical signals produced by the brain. These signals are recorded by a machine and are looked at by a doctoris | Device | 50 epileptic patients receive SV for 6 months , for whom add lamotrigine for 6 month |
Primary outcome
Weight
Time frame: 6 months
Weight in kilogramme will be measured in 50 participants
5 secondary outcomes
liver function tests
Time frame: 6months
serum ammonia.
Time frame: 6months
complete blood count
Time frame: 6 months
E.E.G
Time frame: 6months
Serum concentration of LTG
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Background: PubMed 9373804Altunbasak S, Baytok V, Tasouji M, Herguner O, Burgut R, Kayrin L. Asymptomatic hyperammonemia in children treated with valproic acid. J Child Neurol. 1997 Oct;12(7):461-3. doi: 10.1177/088307389701200709. No abstract available.
- Background: PubMed 31337135Armeno M, Verini A, Del Pino M, Araujo MB, Mestre G, Reyes G, Caraballo RH. A Prospective Study on Changes in Nutritional Status and Growth Following Two Years of Ketogenic Diet (KD) Therapy in Children with Refractory Epilepsy. Nutrients. 2019 Jul 14;11(7):1596. doi: 10.3390/nu11071596.
- Background: PubMed 31099271Balagura G, Iapadre G, Verrotti A, Striano P. Moving beyond sodium valproate: choosing the right anti-epileptic drug in children. Expert Opin Pharmacother. 2019 Aug;20(12):1449-1456. doi: 10.1080/14656566.2019.1617850. Epub 2019 May 17.
- Background: PubMed 27129611Cavus I, Romanyshyn JC, Kennard JT, Farooque P, Williamson A, Eid T, Spencer SS, Duckrow R, Dziura J, Spencer DD. Elevated basal glutamate and unchanged glutamine and GABA in refractory epilepsy: Microdialysis study of 79 patients at the yale epilepsy surgery program. Ann Neurol. 2016 Jul;80(1):35-45. doi: 10.1002/ana.24673. Epub 2016 Jun 13.
- Background: PubMed 19424520Fassi G, Igoa A, Liste OA. [Valproate-induced hyperammonemic encephalopathy. Review of cases in the psychiatric setting]. Vertex. 2008 Nov-Dec;19(82):371-7. Spanish.
- Background: PubMed 36345310Deng J, Fu ZR, Wang L, Liu J, Chen CH, Fang F, Wang XL. Acute liver failure associated with lamotrigine in children with epilepsy: A report of two cases and thoughts on pharmacogenomics. Epilepsy Behav Rep. 2022 Oct 19;20:100568. doi: 10.1016/j.ebr.2022.100568. eCollection 2022.
- Background: PubMed 31512113Fu J, Peng L, Wang W, He H, Zeng S, Chen TC, Chen Y. Sodium Valproate Reduces Neuronal Apoptosis in Acute Pentylenetetrzole-Induced Seizures via Inhibiting ER Stress. Neurochem Res. 2019 Nov;44(11):2517-2526. doi: 10.1007/s11064-019-02870-w. Epub 2019 Sep 11.
- Background: PubMed 19280426Lheureux PE, Hantson P. Carnitine in the treatment of valproic acid-induced toxicity. Clin Toxicol (Phila). 2009 Feb;47(2):101-11. doi: 10.1080/15563650902752376.
- Background: PubMed 32765764Zhang D, Qiu L, Zhang Y, Sang Y, Zheng N, Liu X. Efficacy and safety of sodium valproate plus lamotrigine in children with refractory epilepsy. Exp Ther Med. 2020 Sep;20(3):2698-2704. doi: 10.3892/etm.2020.8984. Epub 2020 Jul 10.
- Background: PubMed 30921015Moosa ANV. Antiepileptic Drug Treatment of Epilepsy in Children. Continuum (Minneap Minn). 2019 Apr;25(2):381-407. doi: 10.1212/CON.0000000000000712.
- Individual participant dataSharing planned: Undecided
Related trials for Epilepsy
Not yet recruiting
Clinical Trial of SEEG for Drug-resistant Epilepsy
Drug-Resistant Epilepsy
RecruitingPhase 3
Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults
Seizures, Lennox Gastaut Syndrome
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
Focal Seizure, Epilepsy
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
Focal Seizure, Epilepsy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sodium Valproate 500 Mg Prolonged-Release Oral Tablet, Lamotrigine and E.E.G in people with Epilepsy and Lamotrigine, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact mona M Abdellatief, M.B.B.CH (01124048288, mona.mohammed.@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05881928, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2024.