ADHDNCT07205211
Prevalence of ADHD in Children With Epilepsy
An observational study of ADHD and Epilepsy, run by Assiut University.
Trial summary
To Determine the prevalence of ADHD symptoms in children with epilepsy, And find out the possible risk factors of ADHD in such patients and it's effect on prognosis of the disease Read more about this study
- Who is it for?
- Ages 3 to 18 years
- How many people
- 185 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 1 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The study population will consists of children above 3 years with epilepsy and develop symptoms of ADHD or even have ADHD before diagnosis of epilepsy And compared with those with epilepsy but don't develop ADHD to determine the prevalence,risk factor And the prognosis. participants will be recruited from pediatric neurology unit \& neurology outpatiend clinic in Assuit University Children's Hospital
Who may be able to join
- All children above the age of 3 years who have any type of epilepsy and are seen in the neurology unit in Assiut University Children's Hospital.
Who cannot join
- Children below 3 years of age. Children with ADHD who do not have epilepsy.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Menna alllah Abdelrazek Ali Gad, Principal investigator contact
About this study
Official title: Attention Deficit Hyperactivity Disorder (ADHD) Symptoms in Children With Epilepsy
To Determine the prevalence of ADHD symptoms in children with epilepsy, And find out the possible risk factors of ADHD in such patients and it's effect on prognosis of the disease
Read the detailed description
Epilepsy may be defined as the recurrence of apparently spontaneous seizures and can be a pervasive condition in which the seizures are just one expression Epileptic seizures are transient clinical events resulting from atypical and excessive activity of more or less widespread population of cerebral neurons Epilepsy is a heterogeneous disorder that consists of clinical syndromes, characterized by different types of seizures, and underlying aetiologies . It is the most common pediatric neurological disorder with prevalence estimates of 0.5-1% of all children from birth to 16 years .
Attention deficit/hyperactivity disorder (ADHD) is a common brain disorder with onset in early childhood,due to structural and functional abnormalities in widespread, but specific areas of the brain . ADHD is a frequent co morbidity experienced by children with epilepsy, has a negative impact on their quality of life,and represents a significant risk factor for academic underachievement.
ADHD has been reported in epilepsy since the Fifties of the 20th century .More recently a high association between the two disorders, with an increasing evidence of a bidirectional relationship, has been postulated . Several factors may contribute to this comorbidity, including the underlying brain pathology, the chronic effects of seizures and of the epileptiform EEG discharges, and the effects of antiepileptic drugs. Symptoms of ADHD are more common in some specific types of epilepsies, such as frontal lobe epilepsy, childhood absence epilepsy and Rolandic epilepsy, and may antedate seizure onset in a significant proportion of cases.
Attention problems are frequently reported in children with intractable symptomatic epilepsy, as well as in idiopathic epilepsies . Patients who have generalized epilepsies are more frequently reported to have attentional difficulties than patients suffering from partial seizures. Furthermore, certain epilepsy syndromes may predispose to ADHD-like behavior .ADHD is a prevalent co morbidity of new onset idiopathic epilepsy, associated with a series of cognitive and behavioral complications that antedate epilepsy onset in a significant proportion of cases, and appear related to neurodevelopmental abnormalities in brain structures . The presence of ADHD symptoms at the time of epilepsy onset is a major marker of abnormal cognitive development The mechanisms underlying attention deficits are still unknown and appear to be different between focal and generalized epilepsies. In the clinical practice, this association may represent a challenge for child neurologists since antiepileptic therapy and drugs used to treat ADHD may aggravate the clinical picture of each other .-Treatment with psychotropic drugs can be initiated safely in most children with epilepsy and ADHD symptoms.
Previous studies show that Children with epilepsy have more attention problems as compared with healthy controls. ADHD in childhood epilepsy is associated with male sex, younger age, early first onset age, high frequency of epileptic seizures, and multiple AEDs
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Epilepsy
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in ADHD Symptom Total Score (ADHD-SC4)
The primary outcome will be the change from baseline in the total symptom score, as measured by the ADHD Symptom Checklist-4 Scale (ADHD-SC4), a validated parent-completed rating scale. Efficacy will be determined by a statistically significant reduction in the total score from baseline to the final 12-week assessment compared to control.
Measured: 12 weeks
Secondary outcomes (1)
Change from Baseline in Quality of Life Total Score (PedsQL™ 4.0 Generic Core Scales)
The change from baseline to the final 12-week assessment in the overall Total Score from the Pediatric Quality of Life Inventory™ 4.0 Generic Core Scales (PedsQL). The PedsQL is a validated, patient- and parent-reported scale that assesses daily functioning, social relationships, and emotional health. The total score will be used as the primary QoL metric.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study start1 Jan 2026 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for ADHDStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 185 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Menna Allah Abdelrazek Ali Gad Kassab, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07205211
- Sponsor's protocol ID
- ADHD in pediatric epilepsy
- Status last verified
- Sep 2025
- First submitted
- 13 Sep 2025
- Last updated
- 3 Oct 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kanner 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 18777484Caplan R, Siddarth P, Stahl L, Lanphier E, Vona P, Gurbani S, Koh S, Sankar R, Shields WD. Childhood absence epilepsy: behavioral, cognitive, and linguistic comorbidities. Epilepsia. 2008 Nov;49(11):1838-46. doi: 10.1111/j.1528-1167.2008.01680.x. Epub 2008 Jun 13.
PubMed 18557780Steer CR. Managing attention deficit/hyperactivity disorder: unmet needs and future directions. Arch Dis Child. 2005 Feb;90 Suppl 1(Suppl 1):i19-25. doi: 10.1136/adc.2004.059352.
PubMed 15665152OUNSTED C. The hyperkinetic syndrome in epileptic children. Lancet. 1955 Aug 13;269(6885):303-11. doi: 10.1016/s0140-6736(55)92304-7. No abstract available.
PubMed 13243723Davies S, Heyman I, Goodman R. A population survey of mental health problems in children with epilepsy. Dev Med Child Neurol. 2003 May;45(5):292-5. doi: 10.1017/s0012162203000550.
PubMed 12729141Hermann B, Jones J, Dabbs K, Allen CA, Sheth R, Fine J, McMillan A, Seidenberg M. The frequency, complications and aetiology of ADHD in new onset paediatric epilepsy. Brain. 2007 Dec;130(Pt 12):3135-48. doi: 10.1093/brain/awm227. Epub 2007 Oct 18.
PubMed 17947336Schubert R. Attention deficit disorder and epilepsy. Pediatr Neurol. 2005 Jan;32(1):1-10. doi: 10.1016/j.pediatrneurol.2004.06.007.
PubMed 15607597Dunn DW, Kronenberger WG. Childhood epilepsy, attention problems, and ADHD: review and practical considerations. Semin Pediatr Neurol. 2005 Dec;12(4):222-8. doi: 10.1016/j.spen.2005.12.004.
PubMed 16780293Torres AR, Whitney J, Gonzalez-Heydrich J. Attention-deficit/hyperactivity disorder in pediatric patients with epilepsy: review of pharmacological treatment. Epilepsy Behav. 2008 Feb;12(2):217-33. doi: 10.1016/j.yebeh.2007.08.001. Epub 2007 Dec 11.
PubMed 18065271
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Attention Deficit Hyperactivity Disorder (ADHD) Symptoms in Children With Epilepsy
- ClinicalTrials.gov ID
- NCT07205211
- Acronym / sponsor ID
- ADHD in pediatric epilepsy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 185 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 3 Oct 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.
To Determine the prevalence of ADHD symptoms in children with epilepsy, And find out the possible risk factors of ADHD in such patients and it's effect on prognosis of the disease
Detailed description
Epilepsy may be defined as the recurrence of apparently spontaneous seizures and can be a pervasive condition in which the seizures are just one expression Epileptic seizures are transient clinical events resulting from atypical and excessive activity of more or less widespread population of cerebral neurons Epilepsy is a heterogeneous disorder that consists of clinical syndromes, characterized by different types of seizures, and underlying aetiologies . It is the most common pediatric neurological disorder with prevalence estimates of 0.5-1% of all children from birth to 16 years .
Attention deficit/hyperactivity disorder (ADHD) is a common brain disorder with onset in early childhood,due to structural and functional abnormalities in widespread, but specific areas of the brain . ADHD is a frequent co morbidity experienced by children with epilepsy, has a negative impact on their quality of life,and represents a significant risk factor for academic underachievement.
ADHD has been reported in epilepsy since the Fifties of the 20th century .More recently a high association between the two disorders, with an increasing evidence of a bidirectional relationship, has been postulated . Several factors may contribute to this comorbidity, including the underlying brain pathology, the chronic effects of seizures and of the epileptiform EEG discharges, and the effects of antiepileptic drugs. Symptoms of ADHD are more common in some specific types of epilepsies, such as frontal lobe epilepsy, childhood absence epilepsy and Rolandic epilepsy, and may antedate seizure onset in a significant proportion of cases.
Attention problems are frequently reported in children with intractable symptomatic epilepsy, as well as in idiopathic epilepsies . Patients who have generalized epilepsies are more frequently reported to have attentional difficulties than patients suffering from partial seizures. Furthermore, certain epilepsy syndromes may predispose to ADHD-like behavior .ADHD is a prevalent co morbidity of new onset idiopathic epilepsy, associated with a series of cognitive and behavioral complications that antedate epilepsy onset in a significant proportion of cases, and appear related to neurodevelopmental abnormalities in brain structures . The presence of ADHD symptoms at the time of epilepsy onset is a major marker of abnormal cognitive development The mechanisms underlying attention deficits are still unknown and appear to be different between focal and generalized epilepsies. In the clinical practice, this association may represent a challenge for child neurologists since antiepileptic therapy and drugs used to treat ADHD may aggravate the clinical picture of each other .-Treatment with psychotropic drugs can be initiated safely in most children with epilepsy and ADHD symptoms.
Previous studies show that Children with epilepsy have more attention problems as compared with healthy controls. ADHD in childhood epilepsy is associated with male sex, younger age, early first onset age, high frequency of epileptic seizures, and multiple AEDs
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The study population will consists of children above 3 years with epilepsy and develop symptoms of ADHD or even have ADHD before diagnosis of epilepsy And compared with those with epilepsy but don't develop ADHD to determine the prevalence,risk factor And the prognosis. participants will be recruited from pediatric neurology unit \& neurology outpatiend clinic in Assuit University Children's Hospital
Key inclusion criteria (1 listed)
- All children above the age of 3 years who have any type of epilepsy and are seen in the neurology unit in Assiut University Children's Hospital.
Key exclusion criteria (1 listed)
- Children below 3 years of age. Children with ADHD who do not have epilepsy.
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
Change from Baseline in ADHD Symptom Total Score (ADHD-SC4)
Time frame: 12 weeks
The primary outcome will be the change from baseline in the total symptom score, as measured by the ADHD Symptom Checklist-4 Scale (ADHD-SC4), a validated parent-completed rating scale. Efficacy will be determined by a statistically significant reduction in the total score from baseline to the final 12-week assessment compared to control.
1 secondary outcome
Change from Baseline in Quality of Life Total Score (PedsQL™ 4.0 Generic Core Scales)
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- 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 18557780Caplan R, Siddarth P, Stahl L, Lanphier E, Vona P, Gurbani S, Koh S, Sankar R, Shields WD. Childhood absence epilepsy: behavioral, cognitive, and linguistic comorbidities. Epilepsia. 2008 Nov;49(11):1838-46. doi: 10.1111/j.1528-1167.2008.01680.x. Epub 2008 Jun 13.
- Results publication: PubMed 15665152Steer CR. Managing attention deficit/hyperactivity disorder: unmet needs and future directions. Arch Dis Child. 2005 Feb;90 Suppl 1(Suppl 1):i19-25. doi: 10.1136/adc.2004.059352.
- Results publication: PubMed 13243723OUNSTED C. The hyperkinetic syndrome in epileptic children. Lancet. 1955 Aug 13;269(6885):303-11. doi: 10.1016/s0140-6736(55)92304-7. No abstract available.
- Results publication: PubMed 12729141Davies S, Heyman I, Goodman R. A population survey of mental health problems in children with epilepsy. Dev Med Child Neurol. 2003 May;45(5):292-5. doi: 10.1017/s0012162203000550.
- Results publication: PubMed 17947336Hermann B, Jones J, Dabbs K, Allen CA, Sheth R, Fine J, McMillan A, Seidenberg M. The frequency, complications and aetiology of ADHD in new onset paediatric epilepsy. Brain. 2007 Dec;130(Pt 12):3135-48. doi: 10.1093/brain/awm227. Epub 2007 Oct 18.
- Results publication: PubMed 15607597Schubert R. Attention deficit disorder and epilepsy. Pediatr Neurol. 2005 Jan;32(1):1-10. doi: 10.1016/j.pediatrneurol.2004.06.007.
- Results publication: PubMed 16780293Dunn DW, Kronenberger WG. Childhood epilepsy, attention problems, and ADHD: review and practical considerations. Semin Pediatr Neurol. 2005 Dec;12(4):222-8. doi: 10.1016/j.spen.2005.12.004.
- Results publication: PubMed 18065271Torres AR, Whitney J, Gonzalez-Heydrich J. Attention-deficit/hyperactivity disorder in pediatric patients with epilepsy: review of pharmacological treatment. Epilepsy Behav. 2008 Feb;12(2):217-33. doi: 10.1016/j.yebeh.2007.08.001. Epub 2007 Dec 11.
- Individual participant dataSharing planned: Undecided
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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.
Menna alllah Abdelrazek Ali Gad, Principal investigator contact
Questions about this trial
What is this clinical trial studying?
An observational study of ADHD and Epilepsy, 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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 3 Oct 2025. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Menna alllah Abdelrazek Ali Gad, Principal investigator (+201029070369, Menna.17289507@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in ADHD Symptom Total Score (ADHD-SC4) (time frame: 12 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 NCT07205211, which also lists 9 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 3 Oct 2025; AzTrials last refreshed its copy on 7 Nov 2026.