Epilepsy (Treatment Refractory)NCT06832020
Determinants of Adaptive Behavior Through the Vineland Scale in Pediatric Patients With Severe and Drug-resistant Epilepsy
An observational study of Epilepsy (Treatment Refractory), run by Ana Valeria Duarte Oliveira at 1 site in Brazil.
Trial summary
Our interest in studying how pediatric patients develop after epilepsy surgery stems from the fact that difficult-to-control epilepsy causes changes in the brain's formation or functioning, leading some patients to experience slower development compared to others. Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Epilepsy (Treatment Refractory)
- How many people
- 369 participants
- Where
- 1 siteBrazil
- Study dates
- 7 Jul 2021to 11 Jul 2023
- Phase
- Observational
- 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 0 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: This study was classified as an observational retrospective cohort analysis. A total of 369 patients with chronological age ranging from 0 to 18 years and severe epilepsy that was unresponsive to drug therapy (defined as uncontrolled epilepsy despite the use of one or two combined drugs) were referred to the study. The patients were divided into two groups: a control group consisting of 204 patients without an established epileptogenic focus, and a clinical group comprising 165 patients with a diagnosed epilepsy, both groups, treated at the Ribeirão Preto Epilepsy Surgery Program (CIREP) of the Clinical Hospital of Ribeirão Preto - University of São Paulo (HCFMRP-USP) between 1996 and 2019.
Who may be able to join
- Chronological age ranging from 0 to 18 years
- Severe epilepsy that was unresponsive to drug therapy (defined as uncontrolled epilepsy despite the use of one or two combined drugs) were referred to the study.
Who cannot join
- Involved patients whose parents or responsible relatives had psychiatric disorders
- Patients who were unable to complete the neuropsychological assessment questionnaire.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Center for Pediatric Epilepsy Surgery, University Hospital, Ribeirão Preto Medical School, University of São Paulo, Brazil.
Ribeirão Preto, São Paulo, 14.048-900
About this study
Official title: Avaliação do Desenvolvimento Adaptativo a Longo Prazo após a Cirurgia de Epilepsia em crianças e Adolescentes Farmacorresistentes
Our interest in studying how pediatric patients develop after epilepsy surgery stems from the fact that difficult-to-control epilepsy causes changes in the brain's formation or functioning, leading some patients to experience slower development compared to others. By gaining a better understanding of how pediatrics patients fare after epilepsy surgery, specifically regarding their independence in daily activities (such as bathing or making the bed), their relationships with family and friends, their mobility, and their speech (whether it is understandable) we can learn more about patient recovery. The goal of this research is to determine whether, 4 years after epilepsy surgery, pediatrics patients show improvements in development. This study is important because it investigates what happens to the development of children who have undergone epilepsy surgery after a long period has passed since the procedure. Research focusing on long-term post-surgical outcomes is necessary, especially in pediatrics, as a brain is not fully developed and requires time to recover after surgery.
Read the detailed description
Participation in the study was voluntary, and refusal to participate or withdrawal of consent at any of the three phases of the research did not result in any penalties. We are committed to maintaining the confidentiality of your child's data, and they were not identified. The data related to the clinical information for the purposes of this research were processed and stored in a database at the Epilepsy Surgery Center (CIREP) of the Hospital das Clínicas de Ribeirão Preto, where only the researchers had access via password. These data will be used for research purposes to assist in the planning of therapeutic intervention.
Once the inclusion in this study was identified and confirmed, the data of all patients were analyzed through a review of electronic medical records and the SAME (Medical and Statistical Archive Service) of HCFMRP-USP. The information obtained was stored in an SPSS database and subsequently analyzed. The following variables were collected: sex, age, age at pre- and postoperative neuropsychological assessment, Engel classification, type of surgery, resection, pathology, seizure frequency, dates of assessments, MRI reports, and findings from the Vineland scale related to communication, socialization, daily living skills, motor skills, and conclusions. Only the principal investigator was authorized to handle the database, in accordance with the data protection and confidentiality standards for the information collected from the patients' electronic medical records included in the study.
This study was classified as an observational retrospective cohort analysis. A total of 369 patients with chronological age ranging from 0 to 18 years and severe epilepsy that was unresponsive to drug therapy (defined as uncontrolled epilepsy despite the use of one or two combined drugs) were referred to the study. The patients were divided into two groups: a control group consisting of 204 patients without an established epileptogenic focus, and a clinical group comprising 165 patients with a diagnosed epilepsy, both groups, treated at the Ribeirão Preto Epilepsy Surgery Program (CIREP) of the Clinical Hospital of Ribeirão Preto - University of São Paulo (HCFMRP-USP) between 1996 and 2019.
The statistical analyses were conducted using the IBM SPSS 23.0 for Windows software (Statistical Package for Social Sciences, SPSS Inc., 1989-2004, Chicago, IL, USA). The variables were assessed for normality using the Kolmogorov-Smirnov test. Categorical variables were summarized using frequency counts, relative frequencies, and valid percentages. Continuous variables were presented as means and standard deviations, along with minimum and maximum values, median, and interquartile range. Univariate analysis was undertaken using post hoc Tukey to examine potential etiological differences between-subjects. Statistical analyses were performed using Pearson's correlation test, and multiple linear regression were conducted to identify neurologic predictors of adaptive function. A significance level of 0.05 or less was considered as the threshold for statistical significance.
The sample size was calculated using the G*Power 3.1.9.7 for Windows program (2020). We used Fisher's exact test, where the test power was set to 0.8, and the error probability was set to 0.05, indicating that the ideal total sample size would be 88 patients, distributed in two equally sized groups. We chose to conduct the study with all patients in the CIREP database, resulting in a sample composed of 369 pediatric patients.
- Conditions
- Epilepsy (Treatment Refractory)
- Keywords
- Epilepsy Drug-resistant. Epilepsy Surgery. Vineland. Pediatrics patients
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control group consisting of 204 patients and clinical group comprising 165 patients. | The patients were divided into two groups: a control group consisting of 204 patients without an established epileptogenic focus, and a clinical group comprising 165 patients with a diagnosed epilepsy, both groups, treated at the Ribeirão Preto Epilepsy Surgery Program (CIREP) of the Clinical Hospital of Ribeirão Preto - University of São Paulo (HCFMRP-USP) between 1996 and 2019. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determinants of Changes in Adaptive Scores through the Vineland Scale in Pediatric Patients with Drug-Resistant Epilepsy
Measured: "From enrollment to the end of treatment at 48 months"
Determinants of Changes in Adaptive Scores through the Vineland Scale in Pediatric Patients with Drug-Resistant Epilepsy
In a retrospective study, our objective was to assess the clinical condition of the patients through data such as Vineland Adaptive Behavior Scales (VABS) in pediatric patients with severe, difficult-to-control epilepsy. The VABS assesses various domains, including communication, daily living skills, socialization, and motor skills. The assessments were conducted in a blinded manner to avoid contaminating the data collection and results with any information obtained prior to the completion of the questionnaire.
Regarding the performance of a given activity, a score of 2 indicates "yes, normally," 1 "sometimes or partially," and 0 "no, never." The 'N' scores indicate that the individual "has no opportunity" to perform the activity, and 'D' indicates "unknown," meaning the caregiver or responsible person does not know whether the patient performs the activity. The higher the score, the better the adaptive outcome the patients.
Measured: "From enrollment to the end of treatment at 48 months"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study start7 Jul 2021
- Primary completion18 Jan 2023
- Study completion11 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Epilepsy (Treatment Refractory)Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 369 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ana Valeria Duarte Oliveira
- Sponsor type
- University, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Responsible party
- Sponsor-investigator, Ana Valeria Duarte Oliveira, University of Sao Paulo
- Investigators
- Tonicarlo R Velasco, Doctor, Study director, Center for Pediatric Epilepsy Surgery, University Hospital, Ribeirão Preto Medical School, University of São Paulo, Brazil.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06832020
- Sponsor's protocol ID
- 4.829.087
- Status last verified
- Dec 2024
- First submitted
- 19 Dec 2024
- Last updated
- 18 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A description of the complete protocol study will be provided so that the fases can be fully interpreted.
Publications
Vendrame M, Alexopoulos AV, Boyer K, Gregas M, Haut J, Lineweaver T, Wyllie E, Loddenkemper T. Longer duration of epilepsy and earlier age at epilepsy onset correlate with impaired cognitive development in infancy. Epilepsy Behav. 2009 Nov;16(3):431-5. doi: 10.1016/j.yebeh.2009.08.008. Epub 2009 Sep 19.
PubMed 19767243Nolan MA, Redoblado MA, Lah S, Sabaz M, Lawson JA, Cunningham AM, Bleasel AF, Bye AM. Intelligence in childhood epilepsy syndromes. Epilepsy Res. 2003 Feb;53(1-2):139-50. doi: 10.1016/s0920-1211(02)00261-9.
PubMed 12576175Loring DW, Meador KJ. Cognitive side effects of antiepileptic drugs in children. Neurology. 2004 Mar 23;62(6):872-7. doi: 10.1212/01.wnl.0000115653.82763.07.
PubMed 15037684Pulsifer MB, Brandt J, Salorio CF, Vining EP, Carson BS, Freeman JM. The cognitive outcome of hemispherectomy in 71 children. Epilepsia. 2004 Mar;45(3):243-54. doi: 10.1111/j.0013-9580.2004.15303.x.
PubMed 15009226Howell KB, Harvey AS, Archer JS. Epileptic encephalopathy: Use and misuse of a clinically and conceptually important concept. Epilepsia. 2016 Mar;57(3):343-7. doi: 10.1111/epi.13306. Epub 2016 Jan 18.
PubMed 26778176Fisher RS, Cross JH, D'Souza C, French JA, Haut SR, Higurashi N, Hirsch E, Jansen FE, Lagae L, Moshe SL, Peltola J, Roulet Perez E, Scheffer IE, Schulze-Bonhage A, Somerville E, Sperling M, Yacubian EM, Zuberi SM. Instruction manual for the ILAE 2017 operational classification of seizure types. Epilepsia. 2017 Apr;58(4):531-542. doi: 10.1111/epi.13671. Epub 2017 Mar 8.
PubMed 28276064Gaillard WD, Chiron C, Cross JH, Harvey AS, Kuzniecky R, Hertz-Pannier L, Vezina LG; ILAE, Committee for Neuroimaging, Subcommittee for Pediatric. Guidelines for imaging infants and children with recent-onset epilepsy. Epilepsia. 2009 Sep;50(9):2147-53. doi: 10.1111/j.1528-1167.2009.02075.x. Epub 2009 Apr 6.
PubMed 19389145D'Argenzio L, Colonnelli MC, Harrison S, Jacques TS, Harkness W, Vargha-Khadem F, Scott RC, Cross JH. Cognitive outcome after extratemporal epilepsy surgery in childhood. Epilepsia. 2011 Nov;52(11):1966-72. doi: 10.1111/j.1528-1167.2011.03272.x.
PubMed 22032791
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Avaliação do Desenvolvimento Adaptativo a Longo Prazo após a Cirurgia de Epilepsia em crianças e Adolescentes Farmacorresistentes
- ClinicalTrials.gov ID
- NCT06832020
- Acronym / sponsor ID
- 4.829.087
- Conditions
- Epilepsy (Treatment Refractory)
- Keywords
- Epilepsy Drug-resistant. Epilepsy Surgery. Vineland. Pediatrics patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 369 participants (actual)
- Lead sponsor
- Ana Valeria Duarte OliveiraUniversity, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Study start
- 7 Jul 2021 (actual)
- Primary completion
- 18 Jan 2023 (actual)
- Study completion
- 11 Jul 2023 (actual)
- First posted
- 18 Feb 2025 (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.
Our interest in studying how pediatric patients develop after epilepsy surgery stems from the fact that difficult-to-control epilepsy causes changes in the brain's formation or functioning, leading some patients to experience slower development compared to others. By gaining a better understanding of how pediatrics patients fare after epilepsy surgery, specifically regarding their independence in daily activities (such as bathing or making the bed), their relationships with family and friends, their mobility, and their speech (whether it is understandable) we can learn more about patient recovery. The goal of this research is to determine whether, 4 years after epilepsy surgery, pediatrics patients show improvements in development. This study is important because it investigates what happens to the development of children who have undergone epilepsy surgery after a long period has passed since the procedure. Research focusing on long-term post-surgical outcomes is necessary, especially in pediatrics, as a brain is not fully developed and requires time to recover after surgery.
Detailed description
Participation in the study was voluntary, and refusal to participate or withdrawal of consent at any of the three phases of the research did not result in any penalties. We are committed to maintaining the confidentiality of your child's data, and they were not identified. The data related to the clinical information for the purposes of this research were processed and stored in a database at the Epilepsy Surgery Center (CIREP) of the Hospital das Clínicas de Ribeirão Preto, where only the researchers had access via password. These data will be used for research purposes to assist in the planning of therapeutic intervention.
Once the inclusion in this study was identified and confirmed, the data of all patients were analyzed through a review of electronic medical records and the SAME (Medical and Statistical Archive Service) of HCFMRP-USP. The information obtained was stored in an SPSS database and subsequently analyzed. The following variables were collected: sex, age, age at pre- and postoperative neuropsychological assessment, Engel classification, type of surgery, resection, pathology, seizure frequency, dates of assessments, MRI reports, and findings from the Vineland scale related to communication, socialization, daily living skills, motor skills, and conclusions. Only the principal investigator was authorized to handle the database, in accordance with the data protection and confidentiality standards for the information collected from the patients' electronic medical records included in the study.
This study was classified as an observational retrospective cohort analysis. A total of 369 patients with chronological age ranging from 0 to 18 years and severe epilepsy that was unresponsive to drug therapy (defined as uncontrolled epilepsy despite the use of one or two combined drugs) were referred to the study. The patients were divided into two groups: a control group consisting of 204 patients without an established epileptogenic focus, and a clinical group comprising 165 patients with a diagnosed epilepsy, both groups, treated at the Ribeirão Preto Epilepsy Surgery Program (CIREP) of the Clinical Hospital of Ribeirão Preto - University of São Paulo (HCFMRP-USP) between 1996 and 2019.
The statistical analyses were conducted using the IBM SPSS 23.0 for Windows software (Statistical Package for Social Sciences, SPSS Inc., 1989-2004, Chicago, IL, USA). The variables were assessed for normality using the Kolmogorov-Smirnov test. Categorical variables were summarized using frequency counts, relative frequencies, and valid percentages. Continuous variables were presented as means and standard deviations, along with minimum and maximum values, median, and interquartile range. Univariate analysis was undertaken using post hoc Tukey to examine potential etiological differences between-subjects. Statistical analyses were performed using Pearson's correlation test, and multiple linear regression were conducted to identify neurologic predictors of adaptive function. A significance level of 0.05 or less was considered as the threshold for statistical significance.
The sample size was calculated using the G*Power 3.1.9.7 for Windows program (2020). We used Fisher's exact test, where the test power was set to 0.8, and the error probability was set to 0.05, indicating that the ideal total sample size would be 88 patients, distributed in two equally sized groups. We chose to conduct the study with all patients in the CIREP database, resulting in a sample composed of 369 pediatric patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Control group consisting of 204 patients and clinical group comprising 165 patients. | – | –The patients were divided into two groups: a control group consisting of 204 patients without an established epileptogenic focus, and a clinical group comprising 165 patients with a diagnosed epilepsy, both groups, treated at the Ribeirão Preto Epilepsy Surgery Program (CIREP) of the Clinical Hospital of Ribeirão Preto - University of São Paulo (HCFMRP-USP) between 1996 and 2019. |
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- This study was classified as an observational retrospective cohort analysis. A total of 369 patients with chronological age ranging from 0 to 18 years and severe epilepsy that was unresponsive to drug therapy (defined as uncontrolled epilepsy despite the use of one or two combined drugs) were referred to the study. The patients were divided into two groups: a control group consisting of 204 patients without an established epileptogenic focus, and a clinical group comprising 165 patients with a diagnosed epilepsy, both groups, treated at the Ribeirão Preto Epilepsy Surgery Program (CIREP) of the Clinical Hospital of Ribeirão Preto - University of São Paulo (HCFMRP-USP) between 1996 and 2019.
Key inclusion criteria (2 listed)
- Chronological age ranging from 0 to 18 years
- Severe epilepsy that was unresponsive to drug therapy (defined as uncontrolled epilepsy despite the use of one or two combined drugs) were referred to the study.
Key exclusion criteria (2 listed)
- Involved patients whose parents or responsible relatives had psychiatric disorders
- Patients who were unable to complete the neuropsychological assessment questionnaire.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Determinants of Changes in Adaptive Scores through the Vineland Scale in Pediatric Patients with Drug-Resistant Epilepsy
Time frame: "From enrollment to the end of treatment at 48 months"
Determinants of Changes in Adaptive Scores through the Vineland Scale in Pediatric Patients with Drug-Resistant Epilepsy
Time frame: "From enrollment to the end of treatment at 48 months"
In a retrospective study, our objective was to assess the clinical condition of the patients through data such as Vineland Adaptive Behavior Scales (VABS) in pediatric patients with severe, difficult-to-control epilepsy. The VABS assesses various domains, including communication, daily living skills, socialization, and motor skills. The assessments were conducted in a blinded manner to avoid contaminating the data collection and results with any information obtained prior to the completion of the questionnaire. Regarding the performance of a given activity, a score of 2 indicates "yes, normally," 1 "sometimes or partially," and 0 "no, never." The 'N' scores indicate that the individual "has no opportunity" to perform the activity, and 'D' indicates "unknown," meaning the caregiver or responsible person does not know whether the patient performs the activity. The higher the score, the better the adaptive outcome the patients.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2025.
- Results publication: PubMed 19767243Vendrame M, Alexopoulos AV, Boyer K, Gregas M, Haut J, Lineweaver T, Wyllie E, Loddenkemper T. Longer duration of epilepsy and earlier age at epilepsy onset correlate with impaired cognitive development in infancy. Epilepsy Behav. 2009 Nov;16(3):431-5. doi: 10.1016/j.yebeh.2009.08.008. Epub 2009 Sep 19.
- Results publication: PubMed 12576175Nolan MA, Redoblado MA, Lah S, Sabaz M, Lawson JA, Cunningham AM, Bleasel AF, Bye AM. Intelligence in childhood epilepsy syndromes. Epilepsy Res. 2003 Feb;53(1-2):139-50. doi: 10.1016/s0920-1211(02)00261-9.
- Results publication: PubMed 15037684Loring DW, Meador KJ. Cognitive side effects of antiepileptic drugs in children. Neurology. 2004 Mar 23;62(6):872-7. doi: 10.1212/01.wnl.0000115653.82763.07.
- Results publication: PubMed 15009226Pulsifer MB, Brandt J, Salorio CF, Vining EP, Carson BS, Freeman JM. The cognitive outcome of hemispherectomy in 71 children. Epilepsia. 2004 Mar;45(3):243-54. doi: 10.1111/j.0013-9580.2004.15303.x.
- Results publication: PubMed 26778176Howell KB, Harvey AS, Archer JS. Epileptic encephalopathy: Use and misuse of a clinically and conceptually important concept. Epilepsia. 2016 Mar;57(3):343-7. doi: 10.1111/epi.13306. Epub 2016 Jan 18.
- Results publication: PubMed 28276064Fisher RS, Cross JH, D'Souza C, French JA, Haut SR, Higurashi N, Hirsch E, Jansen FE, Lagae L, Moshe SL, Peltola J, Roulet Perez E, Scheffer IE, Schulze-Bonhage A, Somerville E, Sperling M, Yacubian EM, Zuberi SM. Instruction manual for the ILAE 2017 operational classification of seizure types. Epilepsia. 2017 Apr;58(4):531-542. doi: 10.1111/epi.13671. Epub 2017 Mar 8.
- Results publication: PubMed 19389145Gaillard WD, Chiron C, Cross JH, Harvey AS, Kuzniecky R, Hertz-Pannier L, Vezina LG; ILAE, Committee for Neuroimaging, Subcommittee for Pediatric. Guidelines for imaging infants and children with recent-onset epilepsy. Epilepsia. 2009 Sep;50(9):2147-53. doi: 10.1111/j.1528-1167.2009.02075.x. Epub 2009 Apr 6.
- Results publication: PubMed 22032791D'Argenzio L, Colonnelli MC, Harrison S, Jacques TS, Harkness W, Vargha-Khadem F, Scott RC, Cross JH. Cognitive outcome after extratemporal epilepsy surgery in childhood. Epilepsia. 2011 Nov;52(11):1966-72. doi: 10.1111/j.1528-1167.2011.03272.x.
- Individual participant dataSharing planned: Yes. A description of the complete protocol study will be provided so that the fases can be fully interpreted.
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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.
Tonicarlo R Velasco, Doctor study director
Center for Pediatric Epilepsy Surgery, University Hospital, Ribeirão Preto Medical School, University of São Paulo, Brazil.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy (Treatment Refractory), run by Ana Valeria Duarte Oliveira at 1 site in Brazil.
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 2 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: finished, as of the sponsor's last update on 18 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determinants of Changes in Adaptive Scores through the Vineland Scale in Pediatric Patients with Drug-Resistant Epilepsy (time frame: "From enrollment to the end of treatment at 48 months"). The study lists 2 primary outcomes in all. 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 NCT06832020, which also lists 8 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 18 Feb 2025.