NCT06393309

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
169

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

September 3, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 19, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 19, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 26, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 1, 2024

Completed
Last Updated

May 2, 2024

Status Verified

April 1, 2024

Enrollment Period

1.5 years

First QC Date

April 26, 2024

Last Update Submit

April 30, 2024

Conditions

Treatment of Idiopathic Generalized Epilepsy

Keywords

LevetiracetamValproateIdiopathic generalized epilepsy

Outcome Measures

Primary Outcomes (2)

  • Seizure free rate

    The percent of patients who remained seizure free on treatment

    1 to 5 years

  • Time to first seizure

    The interval between start of treatment and recurrence of seizure

    1 to 5 years

Secondary Outcomes (2)

  • Retention rate

    1 to 5 years

  • Time to withdrawal

    1 to 5 years

Study Arms (2)

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

LevetiracetamDRUG

Patients with idiopathic generalized epilepsy who were under treatment with levetiracetam

Levetiracetam
Sodium valproateDRUG

Patients with idiopathic generalized epilepsy who were under treatment with valproate

Sodium valproate

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

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

You may not qualify if:

  • Poor drug adherence
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bu Ali Sina Hospital

Sari, Mazandaran, 4815837477, Iran

Location

MeSH Terms

Conditions

Epilepsy, Idiopathic Generalized

Interventions

LevetiracetamValproic Acid

Intervention Hierarchy (Ancestors)

AcetamidesAmidesOrganic ChemicalsAcetatesAcids, AcyclicCarboxylic AcidsPyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPentanoic AcidsValeratesFatty Acids, VolatileFatty AcidsLipids

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor of neurology

Study Record Dates

First Submitted

April 26, 2024

First Posted

May 1, 2024

Study Start

September 3, 2022

Primary Completion

March 19, 2024

Study Completion

March 19, 2024

Last Updated

May 2, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

IR(1)