Attention-Deficit Hyperactivity DisorderNCT03806946
Impact of Relationship of Epilepsy and Attention Deficit Hyperactive Disorder
An observational study of Attention-Deficit Hyperactivity Disorder and Epilepsy, run by Assiut University at 1 site in Egypt.
Trial summary
The most common neuropsychiatric disorder in early childhood is attention deficit/hyperactivity disorder (ADHD) with evidence of abnormality in structure and function of brain. Epilepsy is one of the commonest comorbidity associated with ADHD with negative outcome on childrens' quality of life, and is considered to be… Read more about this study
- Who is it for?
- Ages 6 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention-Deficit Hyperactivity Disorder, Epilepsy
- What is being tested?
- electroencephalography, psychometric scales to diagnosis psychiatric disorders and psychometric scales for assesment socioeconomic and behaviour problems
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Feb 2019to 1 Mar 2020
- 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 6 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: childern and adolescent attending psychiatric outpatients clinic of Assiut university who had diagnosis of attention deficit hyperactivity disorder or epilepsy or both and with age (6y-11y)
Who may be able to join
- Both males and females were included.
- Age range from 6- 11 years.
- Diagnosis of ADHD and/or epilepsy was verified and confirmed either on a clinical basis or by using reliable psychometric tests.
- In epilepsy groups: only Idiopathic type was included.
- Willing of the parents or the caregivers to participate in the study.
Who cannot join
- Children whom caretakers refused to give informed consent.
- Children with intelligence quotient below 70.
- Children with history or current substance use.
- Children with medical or other neurological conditions.
Trial locations and contacts
1 site in 1 country.
About this study
The most common neuropsychiatric disorder in early childhood is attention deficit/hyperactivity disorder (ADHD) with evidence of abnormality in structure and function of brain. Epilepsy is one of the commonest comorbidity associated with ADHD with negative outcome on childrens' quality of life, and is considered to be a risk for academic underachievement. These two disorders are highly associated, with more possibility to be a bidirectional relationship. The mechanisms of this comorbidity are unknown. In this association, a difficult challenge is presented since antiepileptic therapy and drugs used to treat ADHD may aggravate the clinical picture of each other. The main objectives are to evaluate this overlap of those disorders, find their complications on child and his family, and to suggest possible solutions to improve the outcome of those children.
Read the detailed description
The commonest childhood disorder is attention deficit hyperactivity disorder(ADHD) which continues into adulthood.The main two symptoms are inattention and hyperactivity.
As epilepsy is one of the commonest comorbidity with ADHD to about (40%), there are many overlap symptoms between both disorders for example:
- Behavioral features which are shared in both frontal lobe epilepsy with ADHD such as impulsivity, disinhibition, and irritability
- The electroencephalogram: there is an increase in the rate of spikes in children with ADHD with no epileptic symptoms, which supports the theory of presence similar mechanism about central nervous system dysfunction.
These reasons lead to increase obstacles for diagnosis, assessment, and treatment for both disorders.
As this comorbidity duplicates the complications (i.e. drop the school, financial cost, stress on families, negative effect on academic, vocational, social relations and self-esteem ) so there is a great need to study this comorbidity to give a proper care for these patients.
In this study, all participants will be enrolled over a period of 12 months from Assiut outpatients clinic .All participants will be assessed in the psychiatric interview by using prepared child and adolescent psychiatric sheet include (psychiatric and neurology history, physical examination and mental state examination). After that electroencephalogram(EEG) will be done to diagnoses epilepsy and identify different types of seizures.
All participants will be categorizing into 4 groups ( ADHD, epilepsy, ADHD,and epilepsy, healthy) according to EEG and the psychiatric sheet. Each group will be assessed by different psychometrics scales to evaluate cognitive, social, economic and behavioral outcome. The results of all groups will be analysed by using Stata version 15 to evaluate the effect of ADHD and epilepsy in children and adolescent and identify the possible risk factors to improve outcome
- Conditions
- Attention-Deficit Hyperactivity Disorder, Epilepsy
- Being tested
- electroencephalography, psychometric scales to diagnosis psychiatric disorders, psychometric scales for assesment socioeconomic and behaviour problems
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electroencephalographyDiagnostic test
Also called EEG
diagnosis epileptic discharge
psychometric scales to diagnosis psychiatric disordersDiagnostic test
Also called WISC III (Wechsler Intelligence Scale for Children),conners 3rd Edition,(cbcl)The Child Behavior Checklis,Epilepsy interview,The Childhood Autism Spectrum Test (CAST)
to diagnosis intellectual disability, attention deficit hyperactivity disorder ,epilepsy,autism and other mental illness.
psychometric scales for assesment socioeconomic and behaviour problemsOther
Also called socioeconomic class, pediatric quality of life inventory, The Strengths and Difficulties Questionnaire (SDQ),The Mood and Feelings Questionnaire (MFQ),
to assessment other behavioural comorbidity as aggression ,mood changes,etc and help in identify function impairment, social and economic burden
| Study group | Role | What they receive |
|---|---|---|
| group1 | ADHD with normal EEG Receives: Diagnostic Test: electroencephalography; Diagnostic Test: psychometric scales to diagnosis psychiatric disorders; Other: psychometric scales for assesment socioeconomic and behaviour problems | |
| group 2 | ADHD with abnormal EEG Receives: Diagnostic Test: electroencephalography; Diagnostic Test: psychometric scales to diagnosis psychiatric disorders; Other: psychometric scales for assesment socioeconomic and behaviour problems | |
| group 3 | Epilepsy Receives: Diagnostic Test: electroencephalography; Diagnostic Test: psychometric scales to diagnosis psychiatric disorders; Other: psychometric scales for assesment socioeconomic and behaviour problems | |
| group 4 | Healthy control group Receives: Diagnostic Test: electroencephalography; Diagnostic Test: psychometric scales to diagnosis psychiatric disorders; Other: psychometric scales for assesment socioeconomic and behaviour problems | |
| group 5 | ADHD and epilepsy Receives: Diagnostic Test: electroencephalography; Diagnostic Test: psychometric scales to diagnosis psychiatric disorders; Other: psychometric scales for assesment socioeconomic and behaviour problems |
What is being measured
The primary outcome is the main question the study is designed to answer.
measure intellectual equations for children with epilepsy and ADHD
WISC-III provided scores for Verbal IQ (VIQ), Performance IQ (PIQ), and Full-Scale IQ (FSIQ).
The child's verbal IQ score was derived from scores on six of the subtests: information, digit span, vocabulary, arithmetic, comprehension, and similarities.
The child's performance IQ was derived from scores on the remaining seven subtests: picture completion, picture arrangement, block design, object assembly, coding, mazes, and symbol search.
The overall intelligence quotient, called the full scale IQ, as well as a verbal IQ and a performance IQ. The three IQ scores are standardized in such a way that a score of 100 is considered average and serves as a benchmark for higher and lower scores.
Measured: baseline
measure socioeconomic class for families and children with comorbid epilepsy and ADHD
It will be measure by Socioeconomic class scale which consist of It contain four main variables 1-the educational level of the father and mother 2-the occupation of the father and mother 3-total family income 4-life style of the family. The total score of the scale equal the sum of scores in each level, the scores 36-42 mean the high socioeconomic class, the scores 21-26 mean the low socioeconomic class, and scores between them mean the middle class.
Measured: baseline
measure mood and feeling changes in children with comorbid epilepsy and ADHD.
It will be measure by Mood and Feelings Questionnaire (MFQ) arent Report is a 13-item measure assessing recent depressive and describe feelings and mood,more than 26 is consider for evaluation of depression
Measured: baseline
measure quality of life for children with comorbid epilepsy and ADHD
It is composed of 23 items that assessment function in the following four areas: physical (eight items), emotional (five items), social (five items), and school (five items). Patients report their function using a 5-point Likert scale ranging from 0 to 4. These responses are reverse scored and linearly transformed to a 0 to 100 scale, with a higher score indicating a higher QOL.
The Psychosocial Health Summary score is a computed mean of the emotional, social, and school functioning subscales of the PedsQL. The physical functioning scale is the same as the Physical Summary score. In addition, the computed mean of the Emotional, Social, School functioning, and Physical scales are used to generate a Total Summary score. PedsQL scales are composed of parallel child self-report and parent-proxy report formats.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2019
- Study start15 Feb 2019
- Primary completion30 Dec 2019
- Study completion1 Mar 2020
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 Attention-Deficit Hyperactivity DisorderStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gellan Karamalllah Ramadan Ahmed, Assiut University
- Investigators
- Alaa El-Din Darweesh, PhD, Study director, Assiut UniversityHossamEddin Ahmad, PhD, Study chair, Assiut UniversityPatrick Bolton, PhD, Study chair, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03806946
- Sponsor's protocol ID
- Impact of ADHD and epilepsy
- Status last verified
- Apr 2020
- First submitted
- 9 May 2018
- Last updated
- 14 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dunn DW, Austin JK, Huster GA. Behaviour problems in children with new-onset epilepsy. Seizure. 1997 Aug;6(4):283-7.
PubMed 9304719Kanner AM. The use of psychotropic drugs in epilepsy: what every neurologist should know. Semin Neurol. 2008 Jul;28(3):379-88. doi: 10.1055/s-2008-1079342. Epub 2008 Jul 24.
PubMed 18777484Chou IC, Chang YT, Chin ZN, Muo CH, Sung FC, Kuo HT, Tsai CH, Kao CH. Correlation between epilepsy and attention deficit hyperactivity disorder: a population-based cohort study. PLoS One. 2013;8(3):e57926. doi: 10.1371/journal.pone.0057926. Epub 2013 Mar 6.
PubMed 23483944Sherman EM, Slick DJ, Connolly MB, Eyrl KL. ADHD, neurological correlates and health-related quality of life in severe pediatric epilepsy. Epilepsia. 2007 Jun;48(6):1083-91. doi: 10.1111/j.1528-1167.2007.01028.x. Epub 2007 Mar 22.
PubMed 17381442Kaufmann R, Goldberg-Stern H, Shuper A. Attention-deficit disorders and epilepsy in childhood: incidence, causative relations and treatment possibilities. J Child Neurol. 2009 Jun;24(6):727-33. doi: 10.1177/0883073808330165.
PubMed 19491115Kirov R, Kinkelbur J, Banaschewski T, Rothenberger A. Sleep patterns in children with attention-deficit/hyperactivity disorder, tic disorder, and comorbidity. J Child Psychol Psychiatry. 2007 Jun;48(6):561-70. doi: 10.1111/j.1469-7610.2007.01729.x.
PubMed 17537072Dickstein, L.J., Roba, M.B. and Oldham, J.M.(1997): Review of psychiatry. AmericanPsychiatric Press. Washington, DC. London,England.
Ahmed GK, Darwish AM, Khalifa H, Khashbah MA. Evaluation of psychiatric comorbidity in attention-deficit hyperactivity disorder with epilepsy: A case-control study. Epilepsy Res. 2021 Jan;169:106505. doi: 10.1016/j.eplepsyres.2020.106505. Epub 2020 Nov 21.
PubMed 33302225
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Relationship of Epilepsy and Attention Deficit Hyperactive Disorder
- ClinicalTrials.gov ID
- NCT03806946
- Acronym / sponsor ID
- Impact of ADHD and epilepsy
- Conditions
- Attention-Deficit Hyperactivity Disorder, Epilepsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Feb 2019 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 16 Jan 2019 (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 most common neuropsychiatric disorder in early childhood is attention deficit/hyperactivity disorder (ADHD) with evidence of abnormality in structure and function of brain. Epilepsy is one of the commonest comorbidity associated with ADHD with negative outcome on childrens' quality of life, and is considered to be a risk for academic underachievement. These two disorders are highly associated, with more possibility to be a bidirectional relationship. The mechanisms of this comorbidity are unknown. In this association, a difficult challenge is presented since antiepileptic therapy and drugs used to treat ADHD may aggravate the clinical picture of each other. The main objectives are to evaluate this overlap of those disorders, find their complications on child and his family, and to suggest possible solutions to improve the outcome of those children.
Detailed description
The commonest childhood disorder is attention deficit hyperactivity disorder(ADHD) which continues into adulthood.The main two symptoms are inattention and hyperactivity.
As epilepsy is one of the commonest comorbidity with ADHD to about (40%), there are many overlap symptoms between both disorders for example:
- Behavioral features which are shared in both frontal lobe epilepsy with ADHD such as impulsivity, disinhibition, and irritability
- The electroencephalogram: there is an increase in the rate of spikes in children with ADHD with no epileptic symptoms, which supports the theory of presence similar mechanism about central nervous system dysfunction.
These reasons lead to increase obstacles for diagnosis, assessment, and treatment for both disorders.
As this comorbidity duplicates the complications (i.e. drop the school, financial cost, stress on families, negative effect on academic, vocational, social relations and self-esteem ) so there is a great need to study this comorbidity to give a proper care for these patients.
In this study, all participants will be enrolled over a period of 12 months from Assiut outpatients clinic .All participants will be assessed in the psychiatric interview by using prepared child and adolescent psychiatric sheet include (psychiatric and neurology history, physical examination and mental state examination). After that electroencephalogram(EEG) will be done to diagnoses epilepsy and identify different types of seizures.
All participants will be categorizing into 4 groups ( ADHD, epilepsy, ADHD,and epilepsy, healthy) according to EEG and the psychiatric sheet. Each group will be assessed by different psychometrics scales to evaluate cognitive, social, economic and behavioral outcome. The results of all groups will be analysed by using Stata version 15 to evaluate the effect of ADHD and epilepsy in children and adolescent and identify the possible risk factors to improve outcome
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| group1 | – | Diagnostic Test: electroencephalography, Diagnostic Test: psychometric scales to diagnosis psychiatric disorders, Other: psychometric scales for assesment socioeconomic and behaviour problemsADHD with normal EEG |
| group 2 | – | Diagnostic Test: electroencephalography, Diagnostic Test: psychometric scales to diagnosis psychiatric disorders, Other: psychometric scales for assesment socioeconomic and behaviour problemsADHD with abnormal EEG |
| group 3 | – | Diagnostic Test: electroencephalography, Diagnostic Test: psychometric scales to diagnosis psychiatric disorders, Other: psychometric scales for assesment socioeconomic and behaviour problemsEpilepsy |
| group 4 | – | Diagnostic Test: electroencephalography, Diagnostic Test: psychometric scales to diagnosis psychiatric disorders, Other: psychometric scales for assesment socioeconomic and behaviour problemsHealthy control group |
| group 5 | – | Diagnostic Test: electroencephalography, Diagnostic Test: psychometric scales to diagnosis psychiatric disorders, Other: psychometric scales for assesment socioeconomic and behaviour problemsADHD and epilepsy |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- childern and adolescent attending psychiatric outpatients clinic of Assiut university who had diagnosis of attention deficit hyperactivity disorder or epilepsy or both and with age (6y-11y)
Key inclusion criteria (5 listed)
- Both males and females were included.
- Age range from 6- 11 years.
- Diagnosis of ADHD and/or epilepsy was verified and confirmed either on a clinical basis or by using reliable psychometric tests.
- In epilepsy groups: only Idiopathic type was included.
- Willing of the parents or the caregivers to participate in the study.
Key exclusion criteria (4 listed)
- Children whom caretakers refused to give informed consent.
- Children with intelligence quotient below 70.
- Children with history or current substance use.
- Children with medical or other neurological conditions.
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 |
|---|---|---|
| electroencephalographyAlso: EEGdiagnosis epileptic discharge | Diagnostic test | group 2, group 3, group 4, group 5, group1 |
| psychometric scales to diagnosis psychiatric disordersAlso: WISC III (Wechsler Intelligence Scale for Children),conners 3rd Edition,(cbcl)The Child Behavior Checklis,Epilepsy interview,The Childhood Autism Spectrum Test (CAST)to diagnosis intellectual disability, attention deficit hyperactivity disorder ,epilepsy,autism and other mental illness. | Diagnostic test | group 2, group 3, group 4, group 5, group1 |
| psychometric scales for assesment socioeconomic and behaviour problemsAlso: socioeconomic class, pediatric quality of life inventory, The Strengths and Difficulties Questionnaire (SDQ),The Mood and Feelings Questionnaire (MFQ),to assessment other behavioural comorbidity as aggression ,mood changes,etc and help in identify function impairment, social and economic burden | Other | group 2, group 3, group 4, group 5, group1 |
Primary outcome
measure intellectual equations for children with epilepsy and ADHD
Time frame: baseline
WISC-III provided scores for Verbal IQ (VIQ), Performance IQ (PIQ), and Full-Scale IQ (FSIQ). The child's verbal IQ score was derived from scores on six of the subtests: information, digit span, vocabulary, arithmetic, comprehension, and similarities. The child's performance IQ was derived from scores on the remaining seven subtests: picture completion, picture arrangement, block design, object assembly, coding, mazes, and symbol search. The overall intelligence quotient, called the full scale IQ, as well as a verbal IQ and a performance IQ. The three IQ scores are standardized in such a way that a score of 100 is considered average and serves as a benchmark for higher and lower scores.
measure socioeconomic class for families and children with comorbid epilepsy and ADHD
Time frame: baseline
It will be measure by Socioeconomic class scale which consist of It contain four main variables 1-the educational level of the father and mother 2-the occupation of the father and mother 3-total family income 4-life style of the family. The total score of the scale equal the sum of scores in each level, the scores 36-42 mean the high socioeconomic class, the scores 21-26 mean the low socioeconomic class, and scores between them mean the middle class.
measure mood and feeling changes in children with comorbid epilepsy and ADHD.
Time frame: baseline
It will be measure by Mood and Feelings Questionnaire (MFQ) arent Report is a 13-item measure assessing recent depressive and describe feelings and mood,more than 26 is consider for evaluation of depression
measure quality of life for children with comorbid epilepsy and ADHD
Time frame: baseline
It is composed of 23 items that assessment function in the following four areas: physical (eight items), emotional (five items), social (five items), and school (five items). Patients report their function using a 5-point Likert scale ranging from 0 to 4. These responses are reverse scored and linearly transformed to a 0 to 100 scale, with a higher score indicating a higher QOL. The Psychosocial Health Summary score is a computed mean of the emotional, social, and school functioning subscales of the PedsQL. The physical functioning scale is the same as the Physical Summary score. In addition, the computed mean of the Emotional, Social, School functioning, and Physical scales are used to generate a Total Summary score. PedsQL scales are composed of parallel child self-report and parent-proxy report formats.
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 14 Apr 2020.
- Results publication: PubMed 9304719Dunn DW, Austin JK, Huster GA. Behaviour problems in children with new-onset epilepsy. Seizure. 1997 Aug;6(4):283-7.
- Results publication: PubMed 18777484Kanner AM. The use of psychotropic drugs in epilepsy: what every neurologist should know. Semin Neurol. 2008 Jul;28(3):379-88. doi: 10.1055/s-2008-1079342. Epub 2008 Jul 24.
- Results publication: PubMed 23483944Chou IC, Chang YT, Chin ZN, Muo CH, Sung FC, Kuo HT, Tsai CH, Kao CH. Correlation between epilepsy and attention deficit hyperactivity disorder: a population-based cohort study. PLoS One. 2013;8(3):e57926. doi: 10.1371/journal.pone.0057926. Epub 2013 Mar 6.
- Results publication: PubMed 17381442Sherman EM, Slick DJ, Connolly MB, Eyrl KL. ADHD, neurological correlates and health-related quality of life in severe pediatric epilepsy. Epilepsia. 2007 Jun;48(6):1083-91. doi: 10.1111/j.1528-1167.2007.01028.x. Epub 2007 Mar 22.
- Results publication: PubMed 19491115Kaufmann R, Goldberg-Stern H, Shuper A. Attention-deficit disorders and epilepsy in childhood: incidence, causative relations and treatment possibilities. J Child Neurol. 2009 Jun;24(6):727-33. doi: 10.1177/0883073808330165.
- Results publication: PubMed 17537072Kirov R, Kinkelbur J, Banaschewski T, Rothenberger A. Sleep patterns in children with attention-deficit/hyperactivity disorder, tic disorder, and comorbidity. J Child Psychol Psychiatry. 2007 Jun;48(6):561-70. doi: 10.1111/j.1469-7610.2007.01729.x.
- Results publicationDickstein, L.J., Roba, M.B. and Oldham, J.M.(1997): Review of psychiatry. AmericanPsychiatric Press. Washington, DC. London,England.
- Derived from this study: PubMed 33302225Ahmed GK, Darwish AM, Khalifa H, Khashbah MA. Evaluation of psychiatric comorbidity in attention-deficit hyperactivity disorder with epilepsy: A case-control study. Epilepsy Res. 2021 Jan;169:106505. doi: 10.1016/j.eplepsyres.2020.106505. Epub 2020 Nov 21.
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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.
Alaa El-Din Darweesh, PhD study director
Assiut University
HossamEddin Ahmad, PhD study chair
Assiut University
Patrick Bolton, PhD study chair
King's College London
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 Attention-Deficit Hyperactivity Disorder and Epilepsy, run by Assiut University at 1 site in Egypt.
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 5 inclusion and 4 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 14 Apr 2020. 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 Egypt. 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?
measure intellectual equations for children with epilepsy and ADHD (time frame: baseline). The study lists 4 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 NCT03806946, 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 14 Apr 2020.