NCT07205211

Brief 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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
185

participants targeted

Target at P50-P75 for all trials

Timeline
10mo left

Started Jan 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress30%
Jan 2026Mar 2027

First Submitted

Initial submission to the registry

September 13, 2025

Completed
20 days until next milestone

First Posted

Study publicly available on registry

October 3, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

October 3, 2025

Status Verified

September 1, 2025

Enrollment Period

1 year

First QC Date

September 13, 2025

Last Update Submit

October 2, 2025

Conditions

ADHDEpilepsy

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 weeks

Secondary Outcomes (1)

  • Change from Baseline in Quality of Life Total Score (PedsQL™ 4.0 Generic Core Scales)

    12 weeks

Eligibility Criteria

Age3 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
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

You may qualify if:

  • 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.

You may not qualify if:

  • Children below 3 years of age. Children with ADHD who do not have epilepsy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (9)

  • 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.

    PMID: 18777484RESULT

  • Caplan 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.

    PMID: 18557780RESULT

  • Steer 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.

    PMID: 15665152RESULT

  • OUNSTED 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.

    PMID: 13243723RESULT

  • Davies 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.

    PMID: 12729141RESULT

  • Hermann 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.

    PMID: 17947336RESULT

  • Schubert R. Attention deficit disorder and epilepsy. Pediatr Neurol. 2005 Jan;32(1):1-10. doi: 10.1016/j.pediatrneurol.2004.06.007.

    PMID: 15607597RESULT

  • Dunn 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.

    PMID: 16780293RESULT

  • Torres 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.

    PMID: 18065271RESULT

MeSH Terms

Conditions

Attention Deficit Disorder with HyperactivityEpilepsy

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Central Study Contacts

Menna alllah Abdelrazek Ali Gad, Principal investigator

CONTACT

+201029070369Menna.17289507@med.aun.edu.eg

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

September 13, 2025

First Posted

October 3, 2025

Study Start

January 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

October 3, 2025

Record last verified: 2025-09