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CompletedNCT06393309LEVAGEUpdated May 2, 2024

Levetiracetam Versus Valproate in Idiopathic Generalized Epilepsy

An observational study in Treatment of Idiopathic Generalized Epilepsy, sponsored by Mazandaran University of Medical Sciences. Completed at 1 site in Iran, Islamic Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-02.

Sponsored by Mazandaran University of Medical Sciences · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
169
Ages
18 Years and older
Sex
All
01

Study summary

This study aimed to compare the long-term efficacy and safety of levetiracetam and valproate in treatment of idiopathic generalized epilepsy.

02

Conditions studied

  • Treatment of Idiopathic Generalized Epilepsy

Keywords

  • Levetiracetam
  • Valproate
  • Idiopathic generalized epilepsy
03

In context

Epilepsy, Idiopathic Generalized

35 studies on the registry are indexed under Epilepsy, Idiopathic Generalized; 4 are open to participants now.

Browse Epilepsy, Idiopathic Generalized studies →

Lead sponsor

Mazandaran University of Medical Sciences is the lead sponsor of 22 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Adult patients with idiopathic generalized epilepsy (juvenile myoclonic epilepsy or generalized tonic-clonic seizure alone) who are on monotherapy with levetiracetam or sodium valproate

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Diagnosis of juvenile myoclonic epilepsy or generalized tonic-clonic seizure alone
  • Regular monotherapy with levetiracetam or sodium valproate

Exclusion criteria

Exclusion Criteria:

  • Poor drug adherence
  • Pregnancy
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
169 participants (actual)
Patient registry
No

Groups and cohorts

  • Levetiracetam

    Patients with idiopathic generalized epilepsy who were under treatment with levetiracetam

    Drug: Levetiracetam

  • Sodium valproate

    Patients with idiopathic generalized epilepsy who were under treatment with valproate

    Drug: Sodium valproate

Interventions

  • DrugLevetiracetam

    Patients with idiopathic generalized epilepsy who were under treatment with levetiracetam

  • DrugSodium valproate

    Patients with idiopathic generalized epilepsy who were under treatment with valproate

06

What researchers measure

Primary outcomes

  1. Seizure free rate

    The percent of patients who remained seizure free on treatment

    Time frame: 1 to 5 years

  2. Time to first seizure

    The interval between start of treatment and recurrence of seizure

    Time frame: 1 to 5 years

Secondary outcomes

  1. Retention rate

    The percent of patients who remained on treatment with levetiracetam or valproate

    Time frame: 1 to 5 years

  2. Time to withdrawal

    The interval between start and withdrawal of treatment

    Time frame: 1 to 5 years

07

Study locations

1 site
  • Bu Ali Sina Hospital
    Sari, Mazandaran 4815837477, Iran, Islamic Republic of
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Sep 2022 to primary completion in Mar 2024, 18 months.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 26, 2024
First posted
May 1, 2024
StartActual
Sep 3, 2022
Primary completionActual
Mar 19, 2024
CompletionActual
Mar 19, 2024
Last update
May 2, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 2, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06393309
Lead sponsor
Mazandaran University of Medical Sciences
Responsible party
Nasim Tabrizi (Associate professor of neurology, Mazandaran University of Medical Sciences) — Principal investigator
First posted
May 1, 2024
Start date
Sep 3, 2022
Primary completion
Mar 19, 2024
Completion
Mar 19, 2024
Last update
May 2, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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