Drug Resistant EpilepsyPhase 4NCT05697614
The Benefit and Safety of Older Generation Anti-Epileptic Drugs (AEDs) in Drug-Resistant Epilepsy Children
A Phase 4 study testing Valproic acid, Carbamazepin and Phenytoin in people with Drug Resistant Epilepsy, run by Dr Cipto Mangunkusumo General Hospital at 3 sites in Indonesia.
Trial summary
The goal of this interventional study is to learn about the efficacy and safety of first line anti epileptic drugs (AEDs) as substitution therapy for children who are resistant to second-line AEDs. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Drug Resistant Epilepsy
- What is being tested?
- Valproic acid, Carbamazepin and Phenytoin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesIndonesia
- Study dates
- 1 Mar 2023to 30 Jun 2023
- 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 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children age at 1 - 18 years old
- Children diagnosed as drug-resistant epilepsy by pediatric neurologists, diagnosis was based on the ILAE 2017 criteria
- Children will have got at least 3 months of combination therapy that consists of levetiracetam of topiramate with optimal dosage but haven't got seizure reduction
Who cannot join
- Non-convulsive epilepsy
- Suffered from status epilepticus in the prior 3 months before the study begins Past medical history of idiosyncrasies or severe adverse drug reactions caused by the
- substitution therapy that will be given
Trial locations and contacts
3 sites in 1 country.
Indonesia3 sites, 3 recruiting
- Recruiting
Harapan Kita Hospital
Jakarta, 11420
R. Anna Tjandrajani, +628129114513
- Recruiting
Fatmawati Hospital
Jakarta, 12430
Deddy Ria, +628121050511
- Recruiting
Cipto Mangunkusumo Hospital
Jakarta Pusat, Jakarta Special Capital Region, 10430
Irawan Mangunatmadja, +6281314578483, Irawanma2802@gmail.com
About this study
Official title: The Efficacy and Safety of First-Line Anti-Epileptic Drugs (AEDs) as Substitution Therapy in Children Who Are Resistant to Second-Line AEDs
The goal of this interventional study is to learn about the efficacy and safety of first line anti epileptic drugs (AEDs) as substitution therapy for children who are resistant to second-line AEDs. The main question to answer it aims are :
how much the difference proportion of responders (responders are children who achieve the decrease of seizure frequencies by 50%) how much time it is needed to achieve the decrease of seizure frequencies by 50% The patients who are eligible for the study and have given their consent, will be enrolled, divided into 2 groups, the control and intervention.
The participant should follow the 14 weeks of intervention that consists of 6 phases : baseline, initial dose, titration dose, maintenance dose, tapering-off dose, and new combination maintenance dose.
Read the detailed description
Each phase of the study is described below
In baseline phase, data such as demographic, clinical characteristic including seizure frequency, seizure type, seizure onset, medication history, family history of seizure, and also developmental stages, will be recorded from electronic medical record. Besides, the CT-scan or MRI are also collected from the same source. After that, their quality of life will be assessed by QOLCE-55 validated questionnaire through self-guided report. Furthermore, the laboratory investigation and EEG will be performed.
The next phase is intervention phase, started from initial phase and ended by the maintenance of new combination therapy phase, takes with overall 12 weeks. Initially, the substitution drugs with each initial dose are consumed. The drugs consist of valproic acid for the generalized and carbamazepine for focal epilepsies.
On the other hand, the control group will take lamotrigine or clobazam for generalized and oxcarbazepine for focal ones. The phase continuous to titration dose, in which, the dose is raised gradually until it causes 50% of seizure reduction, and the next step is maintained the dose for about 2 weeks.
- The following is tapering-off and after that stopping the substituted drug, levetiracetam or topiramate, which is determined by considering individual condition. Yet, if the seizures increase more than one and a half time of the previous frequency during the phases, the intervention will be ended immediately. On the contrary, if the condition is better, then the children go to the maintenance of new combination, that is the substitution drug and the old drugs in which the seizures do not go up or even better keep going down.
- Conditions
- Drug Resistant Epilepsy
- Being tested
- Valproic acid, Carbamazepin, Phenytoin, Lamotrigine, Clobazam
- Keywords
- anti-epilepsy drug, children, epilepsy, resistant
- Medical subject headings
- Drug Resistant Epilepsy, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valproic acidDrug
Also called sodium divalproex, depaken
valproic acid is used for general epilepsy type, used in experimental group
CarbamazepinDrug
Also called tegretol, bamgetol
carbamazepine is used for focal type epilepsy, used in experimental group
PhenytoinDrug
Also called kutoine
phenytoin is used for both general or focal epilepsy in case valproic acid or carbamazepine is contraindicated, used in experimental group
LamotrigineDrug
Also called lamictal
lamotrigine is used for general epilepsy type, used in control group
ClobazamDrug
Also called frisium
clobazam is used for both general or focal epilepsy in case if lamotrigine or oxcarbazepine is not possible to be administered and is used particularly in myoclonic jerk , used in control group
OxcarbazepineDrug
Also called trileptal
oxcarbazepine is used for focal type epilepsy, used in control group
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | valproic acid 15 - 60 mg/kg body weight/day, divided into 2 dosages/day for 12 weeks ; carbamazepine 10 - 30 mg/kg body weight/day, divided into 2 dosages/day for 12 weeks ; phenytoin 5-7 mg/kg body weight/day, divided into 2 dosages/day for 12 weeks Receives: Drug: Valproic acid; Drug: Carbamazepin; Drug: Phenytoin |
| control | Active comparator | lamotrigine 0.2 mg/kg body weight/day, divided into 2 dosages/day for 12 weeks ; clobazam 0.1 - 0.8 body weight/day, divided into 2 dosages/day for 12 weeks ; oxcarbazepine10 - 30 mg/kg body weight/day, divided into 2 dosages/day for 12 weeks Receives: Drug: Lamotrigine; Drug: Clobazam; Drug: Oxcarbazepine |
What is being measured
The primary outcome is the main question the study is designed to answer.
the different proportion of responders between groups who get first-line anti-epileptic drugs (intervention) and second-line anti-epileptic drugs (control)
responders are children who get the reduction of seizure frequency by 50%
Measured: trough the study completion, about 14 weeks
Secondary outcomes (22)
time to achieve the reduction of seizure frequency by 50% or more among responders
time that is counted in week and is divided into 3 categories , 2-<4 weeks, 4-<8 weeks and 8-12 weeks
Measured: during intervention, about 12 weeks
the difference of quality of life between groups who get first-line anti-epileptic drugs (intervention) and second-line anti-epileptic drugs (control)
quality of life is assessed by validated instrument QOLCE-55. It has 55 questions including cognitive (22 items), emotional (17 items), social (7 items) and also physical (9 items) function. Items are rated on a five-point Likert scale, 0 = very often, 1 = fairly often, 2 = sometime, 3 = almost never, 5 = never. The composite score is the unweighted average of the four subscales, ranging from 1-100, higher score indicates better quality of life. b. Differences in quality of life: quality of life assessment using QOLCE-55 instrument. The average of each function (cognitive, emotional, social and physical functions) and the average of the total functions are assessed. This variable is categorized into:
- Different, if there is a difference in the average quality of life
- Not different, if there is no difference in the average quality of life
Measured: at baseline phase in the 1st week (before intervention) and after intervention in the 14th week
the difference of the electroencephalography (EEG) changing between groups who get first-line anti-epileptic drugs (intervention) and second-line anti-epileptic drugs (control)
The EEG examination is operated two times, at the baseline and post intervention phase, with high density machine (Caldwell Easy III) is done twice, pre- and post-intervention. The machine will operate for about 45 minutes including 5 minutes each for eye-open and eye-close in every subjects. Beginning with acquisition, EEG recordings use standard parameter to analyze brain activity at various frequencies to gain good quality and artefact-free result. The printed results of the EEG is available for about 4-7 days after the examination.
EEG recording results are categorized into:
- Normal : does not show of hypofunction/asymmetry/epileptiform waves
- Abnormal: shows a picture of hypofunction/asymmetry/epileptiform waves or a combination of 1 or more of these features The subjects who show changes in their EEG are later grouped into groups of abnormal to normal or abnormalities that showed improvement. Abnormalities that show improvement, for example are hypofunction (slowing down)
Measured: at baseline phase in the 1st week (before intervention) and after intervention in the 14th week
the description of age in percentage
the data is taken from electronic medical record, age is categorized into <5 years, 5-<10 years, and >/= 10 years
Measured: at baseline phase in the 1st week (before intervention)
the description of seizure onset in percentage
the data is taken from electronic medical record, seizure onset is categorized into <5 years, 5-<10 years, and >/= 10 years
Measured: at baseline phase in the 1st week (before intervention)
the description of gender in percentage
the data is taken from electronic medical record, gender is categorized into male and female
Measured: at baseline phase at 1st week (before intervention)
the description duration of anti epileptic drug medication
the data is taken from electronic medical record, the duration is categorized into <1 year , 1 - <2 year, 2 - 5 year, and > 5 year
Measured: at baseline phase at 1st week (before intervention)
The brain CT or brain MRI
The brain CT or brain MRI are taken from electronic medical record, categorized into normal and abnormal findings. it is categorized as normal if the brain, liquor cerebrospinal and skull is within normal range (no deformation of skull, no hydrocephalus, the brain volume is normal, and no signs of infection such as enhancement, no hemorrhage, no calcification)
Measured: at baseline phase at 1st week (before intervention)
The adverse drug reaction profile in percentage
The adverse drug reaction profile are taken from the diary card, it is categorized into neurology system, gastrointestinal system, musculocutaneous system, renal function, liver function and electrolyte
Measured: during intervention, about 12 weeks
seizure frequency
the frequency is how many times in a month, it is categorized into <5 times, 5-10 times, 10-20 times and > 20 times
Measured: during intervention, about 12 weeks
the history of developmental delayed
the data is taken from electronic medical record, categorized into yes or no. it is named as delayed if the development does not follow the milestone in one or more developmental sectors (language, gross motor skill, fine motor skill, personal social)
Measured: at baseline phase at 1st week (before intervention)
the number of anti-epileptic drug is consumed
the data is taken from electronic medical record, it is categorized into 2 , 3 , or >3 drugs
Measured: at baseline phase at 1st week (before intervention)
the history of seizure in the family
the data is taken from electronic medical record, it is categorized into yes or no
Measured: at baseline phase at 1st week (before intervention)
the association between age and seizure reduction
the age is categorized into <5 years, 5-<10 years, and >/= 10 years ; seizure reduction is categorized into responder and non-responder
Measured: after intervention in the 14th week
the association between seizure onset and seizure reduction
seizure onset is categorized into <5 years, 5-<10 years, and >/= 10 years ; seizure reduction is categorized into responder and non-responder
Measured: after intervention in the 14th week
the association between gender and seizure reduction
gender is categorized into male and female ; seizure reduction is categorized into responder and non-responder
Measured: after intervention in the 14th week
the association between duration of anti epileptic drug medication and seizure reduction
he duration is categorized into <1 year , 1 - <2 year, 2 - 5 year, and > 5 year ; seizure reduction is categorized into responder and non-responder
Measured: after intervention in the 14th week
the association of the brain CT or brain MRI and seizure reduction
the brain CT or brain MRI categorized into normal and abnormal findings. it is categorized as normal if the brain, liquor cerebrospinal and skull is within normal range (no deformation of skull, no hydrocephalus, the brain volume is normal, and no signs of infection such as enhancement, no hemorrhage, no calcification). Seizure reduction is categorized into responder and non-responder
Measured: after intervention in the 14th week
the association of seizure frequency and seizure reduction
the frequency is how many times in a month, it is categorized into <5 times, 5-10 times, 10-20 times and > 20 times. Seizure reduction is categorized into responder and non-responder
Measured: after intervention in the 14th week
the association between the history of developmental delayed and seizure reduction
the history of developmental delayed is categorized into yes or no. it is named as delayed if the development does not follow the milestone in one or more developmental sectors (language, gross motor skill, fine motor skill, personal social). Seizure reduction is categorized into responder and non-responder
Measured: after intervention in the 14th week
the association of the number of anti-epileptic drug is consumed and seizure reduction
number of anti-epileptic drug consumed is categorized into 2 , 3 , or >3 drugs. Seizure reduction is categorized into responder and non-responder
Measured: after intervention in the 14th week
the association between the history of seizure in the family and seizure reduction
the history of seizure in the family is categorized into yes or no. Seizure reduction is categorized into responder and non-responder
Measured: after intervention in the 14th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start1 Mar 2023 (estimated)
- Primary completion30 May 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Drug Resistant EpilepsyStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The subjects will be randomized into 2 groups : intervention and control. The subjects will be recruited by consecutive sampling technique
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr Cipto Mangunkusumo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roro Rukmi Windi Perdani, Dr Cipto Mangunkusumo General Hospital
- Investigators
- Roro Rukmi Windi Perdani Pediatrician, Principal investigator, Cipto Mangunkusumo Hopsital - Medical Faculty of Indonesia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05697614
- Sponsor's protocol ID
- 22-09-1097
- Status last verified
- Jan 2023
- First submitted
- 28 Nov 2022
- Last updated
- 26 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Perdani RRW, Arozal W, Mangunatmadja I, Kaswandani N, Handryastuti S, Medise BE, Hardi H, Thandavarayan RA, Oswari H. The efficacy and safety of first-line anti-seizure medications as substitution therapy for children with drug-resistant epilepsy: a randomized controlled trial protocol. Front Neurol. 2023 Aug 7;14:1237183. doi: 10.3389/fneur.2023.1237183. eCollection 2023.
PubMed 37609651
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of First-Line Anti-Epileptic Drugs (AEDs) as Substitution Therapy in Children Who Are Resistant to Second-Line AEDs
- ClinicalTrials.gov ID
- NCT05697614
- Acronym / sponsor ID
- 22-09-1097
- Conditions
- Drug Resistant Epilepsy
- Keywords
- anti-epilepsy drug, children, epilepsy, resistant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Dr Cipto Mangunkusumo General HospitalUniversity, hospital or other
- Study start
- 1 Mar 2023 (estimated)
- Primary completion
- 30 May 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 26 Jan 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.
The goal of this interventional study is to learn about the efficacy and safety of first line anti epileptic drugs (AEDs) as substitution therapy for children who are resistant to second-line AEDs. The main question to answer it aims are :
how much the difference proportion of responders (responders are children who achieve the decrease of seizure frequencies by 50%) how much time it is needed to achieve the decrease of seizure frequencies by 50% The patients who are eligible for the study and have given their consent, will be enrolled, divided into 2 groups, the control and intervention.
The participant should follow the 14 weeks of intervention that consists of 6 phases : baseline, initial dose, titration dose, maintenance dose, tapering-off dose, and new combination maintenance dose.
Detailed description
Each phase of the study is described below
In baseline phase, data such as demographic, clinical characteristic including seizure frequency, seizure type, seizure onset, medication history, family history of seizure, and also developmental stages, will be recorded from electronic medical record. Besides, the CT-scan or MRI are also collected from the same source. After that, their quality of life will be assessed by QOLCE-55 validated questionnaire through self-guided report. Furthermore, the laboratory investigation and EEG will be performed.
The next phase is intervention phase, started from initial phase and ended by the maintenance of new combination therapy phase, takes with overall 12 weeks. Initially, the substitution drugs with each initial dose are consumed. The drugs consist of valproic acid for the generalized and carbamazepine for focal epilepsies.
On the other hand, the control group will take lamotrigine or clobazam for generalized and oxcarbazepine for focal ones. The phase continuous to titration dose, in which, the dose is raised gradually until it causes 50% of seizure reduction, and the next step is maintained the dose for about 2 weeks.
- The following is tapering-off and after that stopping the substituted drug, levetiracetam or topiramate, which is determined by considering individual condition. Yet, if the seizures increase more than one and a half time of the previous frequency during the phases, the intervention will be ended immediately. On the contrary, if the condition is better, then the children go to the maintenance of new combination, that is the substitution drug and the old drugs in which the seizures do not go up or even better keep going down.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The subjects will be randomized into 2 groups : intervention and control. The subjects will be recruited by consecutive sampling technique
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Drug: Valproic acid, Drug: Carbamazepin, Drug: Phenytoinvalproic acid 15 - 60 mg/kg body weight/day, divided into 2 dosages/day for 12 weeks ; carbamazepine 10 - 30 mg/kg body weight/day, divided into 2 dosages/day for 12 weeks ; phenytoin 5-7 mg/kg body weight/day, divided into 2 dosages/day for 12 weeks |
| control | Active comparator | Drug: Lamotrigine, Drug: Clobazam, Drug: Oxcarbazepinelamotrigine 0.2 mg/kg body weight/day, divided into 2 dosages/day for 12 weeks ; clobazam 0.1 - 0.8 body weight/day, divided into 2 dosages/day for 12 weeks ; oxcarbazepine10 - 30 mg/kg body weight/day, divided into 2 dosages/day for 12 weeks |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Children age at 1 - 18 years old
- Children diagnosed as drug-resistant epilepsy by pediatric neurologists, diagnosis was based on the ILAE 2017 criteria
- Children will have got at least 3 months of combination therapy that consists of levetiracetam of topiramate with optimal dosage but haven't got seizure reduction
Key exclusion criteria (3 listed)
- Non-convulsive epilepsy
- Suffered from status epilepticus in the prior 3 months before the study begins Past medical history of idiosyncrasies or severe adverse drug reactions caused by the
- substitution therapy that will be given
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 |
|---|---|---|
| Valproic acidAlso: sodium divalproex, depakenvalproic acid is used for general epilepsy type, used in experimental group | Drug | intervention |
| CarbamazepinAlso: tegretol, bamgetolcarbamazepine is used for focal type epilepsy, used in experimental group | Drug | intervention |
| PhenytoinAlso: kutoinephenytoin is used for both general or focal epilepsy in case valproic acid or carbamazepine is contraindicated, used in experimental group | Drug | intervention |
| LamotrigineAlso: lamictallamotrigine is used for general epilepsy type, used in control group | Drug | control |
| ClobazamAlso: frisiumclobazam is used for both general or focal epilepsy in case if lamotrigine or oxcarbazepine is not possible to be administered and is used particularly in myoclonic jerk , used in control group | Drug | control |
| OxcarbazepineAlso: trileptaloxcarbazepine is used for focal type epilepsy, used in control group | Drug | control |
Primary outcome
the different proportion of responders between groups who get first-line anti-epileptic drugs (intervention) and second-line anti-epileptic drugs (control)
Time frame: trough the study completion, about 14 weeks
responders are children who get the reduction of seizure frequency by 50%
22 secondary outcomes
time to achieve the reduction of seizure frequency by 50% or more among responders
Time frame: during intervention, about 12 weeks
the difference of quality of life between groups who get first-line anti-epileptic drugs (intervention) and second-line anti-epileptic drugs (control)
Time frame: at baseline phase in the 1st week (before intervention) and after intervention in the 14th week
the difference of the electroencephalography (EEG) changing between groups who get first-line anti-epileptic drugs (intervention) and second-line anti-epileptic drugs (control)
Time frame: at baseline phase in the 1st week (before intervention) and after intervention in the 14th week
the description of age in percentage
Time frame: at baseline phase in the 1st week (before intervention)
the description of seizure onset in percentage
Time frame: at baseline phase in the 1st week (before intervention)
the description of gender in percentage
Time frame: at baseline phase at 1st week (before intervention)
the description duration of anti epileptic drug medication
Time frame: at baseline phase at 1st week (before intervention)
The brain CT or brain MRI
Time frame: at baseline phase at 1st week (before intervention)
The adverse drug reaction profile in percentage
Time frame: during intervention, about 12 weeks
seizure frequency
Time frame: during intervention, about 12 weeks
the history of developmental delayed
Time frame: at baseline phase at 1st week (before intervention)
the number of anti-epileptic drug is consumed
Time frame: at baseline phase at 1st week (before intervention)
the history of seizure in the family
Time frame: at baseline phase at 1st week (before intervention)
the association between age and seizure reduction
Time frame: after intervention in the 14th week
the association between seizure onset and seizure reduction
Time frame: after intervention in the 14th week
the association between gender and seizure reduction
Time frame: after intervention in the 14th week
the association between duration of anti epileptic drug medication and seizure reduction
Time frame: after intervention in the 14th week
the association of the brain CT or brain MRI and seizure reduction
Time frame: after intervention in the 14th week
the association of seizure frequency and seizure reduction
Time frame: after intervention in the 14th week
the association between the history of developmental delayed and seizure reduction
Time frame: after intervention in the 14th week
the association of the number of anti-epileptic drug is consumed and seizure reduction
Time frame: after intervention in the 14th week
the association between the history of seizure in the family and seizure reduction
Time frame: after intervention in the 14th week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
- Derived from this study: PubMed 37609651Perdani RRW, Arozal W, Mangunatmadja I, Kaswandani N, Handryastuti S, Medise BE, Hardi H, Thandavarayan RA, Oswari H. The efficacy and safety of first-line anti-seizure medications as substitution therapy for children with drug-resistant epilepsy: a randomized controlled trial protocol. Front Neurol. 2023 Aug 7;14:1237183. doi: 10.3389/fneur.2023.1237183. eCollection 2023.
- Individual participant dataSharing planned: No
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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.
Roro Rukmi Windi Perdani Pediatrician principal investigator
Cipto Mangunkusumo Hopsital - Medical Faculty of Indonesia University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Valproic acid, Carbamazepin and Phenytoin in people with Drug Resistant Epilepsy, run by Dr Cipto Mangunkusumo General Hospital at 3 sites in Indonesia.
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 3 inclusion and 3 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 26 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Roro Rukmi Windi Perdani Pediatrician (+6281373679940, rororwp@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the different proportion of responders between groups who get first-line anti-epileptic drugs (intervention) and second-line anti-epileptic drugs (control) (time frame: trough the study completion, about 14 weeks). 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 NCT05697614, which also lists 1 linked publication.
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 26 Jan 2023.