EpilepsyPhase 4LEVELNCT07422233
Evaluation of Levetiracetam's Effectiveness and Tolerability for Treating Epilepsy in Older Adults
A Phase 4 study testing Oral levetiracetam in people with Epilepsy and Elderly, run by Nasim Tabrizi at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- What is being tested?
- Oral levetiracetam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 137 participants
- Where
- 1 siteIran
- Study dates
- 13 Sep 2023to 20 Jan 2026
- Phase
- Phase 4
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥60 years
- Diagnosis of epilepsy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Iran1 site
Mazandaran University of medical sciences
Sari, Mazandaran, 4815733971
About this study
Official title: Investigation of Efficacy and Tolerability of Levetiracetam for Epilepsy in Elderly
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.
- Being tested
- Oral levetiracetam
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral levetiracetamDrug
Treatment with levetiracetam tablets
| Study group | Role | What they receive |
|---|---|---|
| Levetiracetam | Other | Elderly patients with epilepsy who have received levetiracetam Receives: Drug: Oral levetiracetam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seizure free rate
The rate of patients who stayed seizure-free after drug initiation
Measured: 12 months
Retention rate
The rate of patients who continue taking drug
Measured: 12 months
Time to first seizure
The interval between starting drug and recurrence of seizure
Measured: at occurrence of first seizure
Time to withdrawal
The interval between starting drug and stoping its use
Measured: the day that the patient stops taking drug
Secondary outcomes (1)
Tolerability rate
the rate of patients that forfeit participation in the study due to adverse effects
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start13 Sep 2023
- Primary completion31 Dec 2025
- Study completion20 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nasim Tabrizi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nasim Tabrizi, Mazandaran University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07422233
- Sponsor's protocol ID
- 11402
- Acronym
- LEVEL
- Status last verified
- Feb 2026
- First submitted
- 5 Feb 2026
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: If requested in certain circumstances.
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Efficacy and Tolerability of Levetiracetam for Epilepsy in Elderly
- ClinicalTrials.gov ID
- NCT07422233
- Acronym / sponsor ID
- LEVEL / 11402
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Nasim TabriziUniversity, hospital or other
- Study start
- 13 Sep 2023 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 20 Jan 2026 (actual)
- First posted
- 19 Feb 2026 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Levetiracetam | Other | Drug: Oral levetiracetamElderly patients with epilepsy who have received levetiracetam |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥60 years
- Diagnosis of epilepsy
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Oral levetiracetamTreatment with levetiracetam tablets | Drug | Levetiracetam |
Primary outcome
Seizure free rate
Time frame: 12 months
The rate of patients who stayed seizure-free after drug initiation
Retention rate
Time frame: 12 months
The rate of patients who continue taking drug
Time to first seizure
Time frame: at occurrence of first seizure
The interval between starting drug and recurrence of seizure
Time to withdrawal
Time frame: the day that the patient stops taking drug
The interval between starting drug and stoping its use
1 secondary outcome
Tolerability rate
Time frame: 12 months
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 19 Feb 2026.
- Individual participant dataSharing planned: No. If requested in certain circumstances.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oral levetiracetam in people with Epilepsy and Elderly, run by Nasim Tabrizi at 1 site in Iran.
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 3 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 19 Feb 2026. 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 Iran. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Seizure free rate (time frame: 12 months). 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?
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 19 Feb 2026.