Evaluation of Levetiracetam's Effectiveness and Tolerabil... | NCT07422233

Studies
Evaluation of Levetiracetam's Effectiveness and Tolerability for Treating Epilepsy in Older Adults

NCT07422233

Sponsor

Nasim Tabrizi

Status

Completed

Last Update Posted

Feb 19, 2026Actual

Enrollment

137Actual

Phase

Phase 4

Conditions

Epilepsy
Elderly

Interventions

Oral levetiracetam

Countries

Iran

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 13, 2023Actual

Primary Completion Date

Dec 31, 2025Actual

Completion Date

Jan 20, 2026Actual

First Submitted Date

Feb 5, 2026

First Submission Date that Met QC Criteria

Feb 12, 2026

First Posted Date

Feb 19, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 12, 2026

Last Update Posted Date

Feb 19, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Nasim Tabrizi, Associate professor of neurology, Mazandaran University of Medical SciencesSponsor-Investigator

Lead Sponsor

Nasim TabriziOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This prospective interventional study was conducted between 2023 and 2025 at the Department of Neurology of Bouali Sina Hospital. Consecutive elderly patients presenting with epilepsy were screened for eligibility. The diagnosis of epilepsy was confirmed by the treating neurologist. The patients underwent treatment with levetiracetam. Primary and secondary outcomes were investigated as was explained before.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

137Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Levetiracetam	Other	Elderly patients with epilepsy who have received levetiracetam	Drug: Oral levetiracetam

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Oral levetiracetam	Drug	Treatment with levetiracetam tablets	Levetiracetam

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Seizure free rate	The rate of patients who stayed seizure-free after drug initiation	12 months
Retention rate	The rate of patients who continue taking drug	12 months
Time to first seizure	The interval between starting drug and recurrence of seizure	at occurrence of first seizure
Time to withdrawal	The interval between starting drug and stoping its use	the day that the patient stops taking drug

Secondary Outcomes

Measure	Description	Time Frame
Tolerability rate	the rate of patients that forfeit participation in the study due to adverse effects	12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age ≥60 years
Diagnosis of epilepsy

Exclusion Criteria:

Chronic kidney disease requiring dialysis
History of psychotic disorders or current use of anxiolytic, antidepressant, or antipsychotic medications
Current use of antiseizure medications for any reason

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mazandaran University of medical sciences		Sari	Mazandaran	4815733971	Iran

IPD Sharing Statement Module

Plan to Share IPD

Description

If requested in certain circumstances.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D004827	Epilepsy

Ancestor Terms

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077287	Levetiracetam

Ancestor Terms

ID	Term
D000081	Acetamides
D000577	Amides
D009930	Organic Chemicals
D000085	Acetates
D000144

Browse Leaves

Not provided

Browse Branches

Not provided