Treatment of Idiopathic Generalized EpilepsyLEVAGENCT06393309
Levetiracetam Versus Valproate in Idiopathic Generalized Epilepsy
An observational study of Treatment of Idiopathic Generalized Epilepsy, run by Mazandaran University of Medical Sciences at 1 site in Iran.
Trial summary
This study aimed to compare the long-term efficacy and safety of levetiracetam and valproate in treatment of idiopathic generalized epilepsy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Treatment of Idiopathic Generalized Epilepsy
- What is being tested?
- Levetiracetam and Sodium valproate
- How many people
- 169 participants
- Where
- 1 siteIran
- Study dates
- 3 Sep 2022to 19 Mar 2024
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Diagnosis of juvenile myoclonic epilepsy or generalized tonic-clonic seizure alone
- Regular monotherapy with levetiracetam or sodium valproate
Who cannot join
- Poor drug adherence
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of Long-term Outcome of Levetiracetam and Valproate in Treatment of Idiopathic Generalized Epilepsy
This study aimed to compare the long-term efficacy and safety of levetiracetam and valproate in treatment of idiopathic generalized epilepsy.
- Being tested
- Levetiracetam, Sodium valproate
- Keywords
- Levetiracetam, Valproate, Idiopathic generalized epilepsy
- Medical subject headings
- Epilepsy, Idiopathic Generalized
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevetiracetamDrug
Patients with idiopathic generalized epilepsy who were under treatment with levetiracetam
Sodium valproateDrug
Patients with idiopathic generalized epilepsy who were under treatment with valproate
| Study group | Role | What they receive |
|---|---|---|
| Levetiracetam | Patients with idiopathic generalized epilepsy who were under treatment with levetiracetam Receives: Drug: Levetiracetam | |
| Sodium valproate | Patients with idiopathic generalized epilepsy who were under treatment with valproate Receives: Drug: Sodium valproate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seizure free rate
The percent of patients who remained seizure free on treatment
Measured: 1 to 5 years
Time to first seizure
The interval between start of treatment and recurrence of seizure
Measured: 1 to 5 years
Secondary outcomes (2)
Retention rate
The percent of patients who remained on treatment with levetiracetam or valproate
Measured: 1 to 5 years
Time to withdrawal
The interval between start and withdrawal of treatment
Measured: 1 to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study start3 Sep 2022
- Primary completion19 Mar 2024
- Study completion19 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment of Idiopathic Generalized 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 169 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mazandaran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nasim Tabrizi, Mazandaran University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06393309
- Sponsor's protocol ID
- 14751
- Acronym
- LEVAGE
- Status last verified
- Apr 2024
- First submitted
- 26 Apr 2024
- Last updated
- 2 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Long-term Outcome of Levetiracetam and Valproate in Treatment of Idiopathic Generalized Epilepsy
- ClinicalTrials.gov ID
- NCT06393309
- Acronym / sponsor ID
- LEVAGE / 14751
- Keywords
- Levetiracetam, Valproate, Idiopathic generalized epilepsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 169 participants (actual)
- Lead sponsor
- Mazandaran University of Medical SciencesUniversity, hospital or other
- Study start
- 3 Sep 2022 (actual)
- Primary completion
- 19 Mar 2024 (actual)
- Study completion
- 19 Mar 2024 (actual)
- First posted
- 1 May 2024 (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 study aimed to compare the long-term efficacy and safety of levetiracetam and valproate in treatment of idiopathic generalized epilepsy.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levetiracetam | – | Drug: LevetiracetamPatients with idiopathic generalized epilepsy who were under treatment with levetiracetam |
| Sodium valproate | – | Drug: Sodium valproatePatients with idiopathic generalized epilepsy who were under treatment with valproate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- Diagnosis of juvenile myoclonic epilepsy or generalized tonic-clonic seizure alone
- Regular monotherapy with levetiracetam or sodium valproate
Key exclusion criteria (2 listed)
- Poor drug adherence
- Pregnancy
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 |
|---|---|---|
| LevetiracetamPatients with idiopathic generalized epilepsy who were under treatment with levetiracetam | Drug | Levetiracetam |
| Sodium valproatePatients with idiopathic generalized epilepsy who were under treatment with valproate | Drug | Sodium valproate |
Primary outcome
Seizure free rate
Time frame: 1 to 5 years
The percent of patients who remained seizure free on treatment
Time to first seizure
Time frame: 1 to 5 years
The interval between start of treatment and recurrence of seizure
2 secondary outcomes
Retention rate
Time frame: 1 to 5 years
Time to withdrawal
Time frame: 1 to 5 years
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 2 May 2024.
- Individual participant dataSharing planned: No
Related trials for Treatment of Idiopathic Generalized Epilepsy
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High-Intensity Focused Ultrasonic Ablation of the Centromedian Thalamic Nucleus for Treatment of Medically Refractory Generalized Epilepsy in Patients Ages 18 Years to 89 Years
Idiopathic Generalized Epilepsy
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?
An observational study of Treatment of Idiopathic Generalized Epilepsy, run by Mazandaran University of Medical Sciences 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 2 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 2 May 2024. 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.
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: 1 to 5 years). The study lists 2 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 2 May 2024.