Epilepsy, Idiopathic GeneralizedPhase 4NCT03940326

Levetiracetam Versus Valproate in Idiopathic Generalized Tonic-clonic Seizures

A Phase 4 study testing Levetiracetam and Valproate in people with Epilepsy, Idiopathic Generalized, run by Mazandaran University of Medical Sciences at 1 site in Iran.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This study is an open-label, active-controlled,non-inferiority trial comparing efficacy and safety of levetiracetam versus valproate in idiopathic generalized tonic-clonic epilepsy. Read more about this study

Who is it for?: Ages 16 years and older
Conditions the study is for: Epilepsy, Idiopathic Generalized
What is being tested?: Levetiracetam and Valproate
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 103 participants
Where: 1 siteIran
Study dates: 1 Apr 2018to 1 Dec 2019
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 16 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Age≥16
At least 2 unprovoked generalized tonic-clonic seizures in last 2 years with at least one in last 6 months
Normal brain MRI or MRI without epileptogenic lesion
Normal electroencephalography(EEG) or existence of generalized epileptiform discharges without any focal epileptiform discharges.
Signing consent form

Who cannot join

History of treatment by sodium valproate or levetiracetam
History of treatment by any anti-epileptic drug in last 6 months
Plan for pregnancy
Using no certain contraceptive method
History of past or current hepatic disease
History of past or current renal disease

Show all 9Show fewer

History of past or current hematologic disease
History of known psychiatric disease
History of status epilepticus

Trial locations and contacts

1 site in 1 country.

Iran1 site

Bu Ali Sina Hospital
Sari, Mazandaran, 4815837477

Other trials in Iran

About this study

Official title: Comparison Study of Efficacy and Safety of Levetiracetam Versus Valproate in Treatment of Idiopathic Generalized Tonic-clonic Seizures

This study is an open-label, active-controlled,non-inferiority trial comparing efficacy and safety of levetiracetam versus valproate in idiopathic generalized tonic-clonic epilepsy.

Conditions: Epilepsy, Idiopathic Generalized
Being tested: Levetiracetam, Valproate
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
Also called Levebel
Levetiracetam with initial dose of 500 mg per 12 hours which will be increased 500 mg/week to target dose of 2000 mg/day and the dose could be increased to 3000 mg/day if seizures recurred
ValproateDrug
Sodium valproate with initial dose of 500 mg/day which will be increased 500 mg/week to target dose of 1500 mg/day and the dose could be increased to 2000 mg/d if seizures recurred.

Study groups in NCT03940326
Study group	Role	What they receive
Levetiracetam	Experimental	Not described Receives: Drug: Levetiracetam
Valproate	Active comparator	Not described Receives: Drug: Valproate

What is being measured

The primary outcome is the main question the study is designed to answer.

Time to First Seizure
The time interval from the beginning of the study to occurrence of the first seizure
Measured: 6 months
Seizure Freedom Rate
Measured: 6 months

Secondary outcomes (2)

Withdrawal Rate
Measured: 6 months
Time to Withdrawal
Measured: 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Apr 20181 Dec 2019

First posted7 May 2019
Study start1 Apr 2018
Primary completion1 Oct 2019
Study completion1 Dec 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Epilepsy, Idiopathic GeneralizedStudies 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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 103 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03940326
Sponsor's protocol ID: LEVIGS
Status last verified: Dec 2021
First submitted: 30 Apr 2019
Last updated: 17 Feb 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruiting
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
RecruitingObservational study
Idiopathic Generalized Epilepsy Syndromes
Epilepsy, Epilepsy, Idiopathic Generalized
RecruitingPhase 2
An Open Label Trial to Evaluate the Efficacy and Safety of PRAX-628 in Adults With Focal Onset or Tonic-Clonic Seizures
Focal Onset Seizure, Primary Generalized Epilepsy
RecruitingObservational study
Idiopathic Generalized Epilepsy Cognitive and Emotional Profile
Epilepsy, Quality of Life

All Epilepsy, Idiopathic Generalized trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison Study of Efficacy and Safety of Levetiracetam Versus Valproate in Treatment of Idiopathic Generalized Tonic-clonic Seizures
ClinicalTrials.gov ID: NCT03940326
Acronym / sponsor ID: LEVIGS
Conditions: Epilepsy, Idiopathic Generalized
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 103 participants (actual)
Lead sponsor: Mazandaran University of Medical SciencesUniversity, hospital or other
Study start: 1 Apr 2018 (actual)
Primary completion: 1 Oct 2019 (actual)
Study completion: 1 Dec 2019 (actual)
First posted: 7 May 2019 (actual)
Results: Posted 17 Feb 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study is an open-label, active-controlled,non-inferiority trial comparing efficacy and safety of levetiracetam versus valproate in idiopathic generalized tonic-clonic epilepsy.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Levetiracetam	Experimental	Drug: Levetiracetam
Valproate	Active comparator	Drug: Valproate

Who may qualify

Ages: 16 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (5 listed)

Age≥16
At least 2 unprovoked generalized tonic-clonic seizures in last 2 years with at least one in last 6 months
Normal brain MRI or MRI without epileptogenic lesion
Normal electroencephalography(EEG) or existence of generalized epileptiform discharges without any focal epileptiform discharges.
Signing consent form

Key exclusion criteria (9 listed)

History of treatment by sodium valproate or levetiracetam
History of treatment by any anti-epileptic drug in last 6 months
Plan for pregnancy
Using no certain contraceptive method
History of past or current hepatic disease

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
LevetiracetamAlso: LevebelLevetiracetam with initial dose of 500 mg per 12 hours which will be increased 500 mg/week to target dose of 2000 mg/day and the dose could be increased to 3000 mg/day if seizures recurred	Drug	Levetiracetam
ValproateSodium valproate with initial dose of 500 mg/day which will be increased 500 mg/week to target dose of 1500 mg/day and the dose could be increased to 2000 mg/d if seizures recurred.	Drug	Valproate

Primary outcome

Time to First Seizure
Time frame: 6 months
The time interval from the beginning of the study to occurrence of the first seizure
Seizure Freedom Rate
Time frame: 6 months

2 secondary outcomes

Withdrawal Rate
Time frame: 6 months
Time to Withdrawal
Time frame: 9 months

Results and safety

Results posted to the registry on 17 Feb 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Levetiracetam	45	45
Valproate	58	58

Primary outcome: Time to First Seizure

Time frame: 6 months. Mean (Standard Deviation). Unit: Days

Measure	Levetiracetam n = 45	Valproate n = 58
Value	169 (6.1)	178 (2.2)

Primary outcome: Seizure Freedom Rate

Time frame: 6 months. Count of participants. Unit: Participants

Measure	Levetiracetam n = 45	Valproate n = 58
Value	40	50

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Levetiracetam	0 of 45 (0%)	17 of 45 (37.8%)	0 of 45
Valproate	2 of 58 (3.4%)	30 of 58 (51.7%)	0 of 58

Limitations and caveats (from the sponsor): 1. The decision to choose between two arms of the study was made based on clinicians' judgment and we could not randomized or blind the study. 2. The current results are based on a 6-month follow up of patients and the results in longer follow up periods might be different. 3. The low number of patients might decrease the power of this study.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Epilepsy, Idiopathic Generalized

RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruiting
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
RecruitingObservational study
Idiopathic Generalized Epilepsy Syndromes
Epilepsy, Epilepsy, Idiopathic Generalized
RecruitingPhase 2
An Open Label Trial to Evaluate the Efficacy and Safety of PRAX-628 in Adults With Focal Onset or Tonic-Clonic Seizures
Focal Onset Seizure, Primary Generalized Epilepsy
RecruitingObservational study
Idiopathic Generalized Epilepsy Cognitive and Emotional Profile
Epilepsy, Quality of Life

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.

Nasim Tabrizi, MD principal investigator

Neurology department, Mazandaran University of Medical Sciences, Sari, Iran.

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 Levetiracetam and Valproate in people with Epilepsy, Idiopathic Generalized, 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 5 inclusion and 9 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 17 Feb 2022. 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?

Yes. Results are posted in the registry (first posted 17 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Time to First Seizure (time frame: 6 months). 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?

On the ClinicalTrials.gov record for NCT03940326.

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 17 Feb 2022.